Anxiety Disorders, Depression, Pain, Post-traumatic Stress Disorder, Substance Related Disorders, Suicide, Traumatic Brain Injury
Conditions
Keywords
Mental health, Veterans health
Brief summary
In this proposal, the investigators extend their previous SPiRE feasibility and preliminary effectiveness study to examine STEP-Home efficacy in a RCT design. This novel therapy will target the specific needs of a broad range of underserved post-9/11 Veterans. It is designed to foster reintegration by facilitating meaningful improvement in the functional skills most central to community participation: emotional regulation (ER), problem solving (PS), and attention functioning (AT). The skills trained in the STEP-Home workshop are novel in their collective use and have not been systematically applied to a Veteran population prior to the investigators' SPiRE study. STEP-Home will equip Veterans with skills to improve daily function, reduce anger and irritability, and assist reintegration to civilian life through return to work, family, and community, while simultaneously providing psychoeducation to promote future engagement in VA care. The innovative nature of the STEP-Home intervention is founded in the fact that it is: (a) an adaptation of an established and efficacious intervention, now applied to post-9/11 Veterans; (b) nonstigmatizing (not therapy but a skills workshop to boost acceptance, adherence and retention); (c) transdiagnostic (open to all post-9/11 Veterans with self-reported reintegration difficulties; Veterans often have multiple mental health diagnoses, but it is not required for enrollment); (d) integrative (focus on the whole person rather than specific and often stigmatizing mental and physical health conditions); (e) comprised of Veteran-specific content to teach participants cognitive behavioral skills needed for successful reintegration (which led to greater acceptability in feasibility study); (f) targets anger and irritability, particularly during interactions with civilians; (g) emphasizes psychoeducation (including other available treatment options for common mental health conditions); and (h) challenges beliefs/barriers to mental health care to increase openness to future treatment and greater mental health treatment utilization. Many Veterans who participated in the development phases of this workshop have gone on to trauma or other focused therapies, or taken on vocational (work/school/volunteer) roles after STEP-Home. The investigators have demonstrated that the STEP-Home workshop is feasible and results in pre-post change in core skill acquisition that the investigators demonstrated to be directly associated with post-workshop improvement in reintegration status in their SPiRE study. Given the many comorbidities of this cohort, the innovative treatment addresses multiple aspects of mental health, cognitive, and emotional function simultaneously and bolsters reintegration in a short-term group to maximize cost-effectiveness while maintaining quality of care.
Detailed description
Post-9/11 Veterans who served in OEF/OIF face many challenges as they re-enter civilian life after structured military careers. Yet, underutilization and resistance to mental health treatment remains a significant problem. Recent investigations of community reintegration problems among returning Veterans found that half of combat Veterans who use Veterans Administration (VA) services reported difficulty in readjusting to civilian life, including difficulty in social functioning, productivity in work and school settings, community involvement, and self-care domains. High rates of marital, family, and cohabitation discord were reported, with 75% reporting a family conflict in the last week. At least one-third reported divorce, dangerous driving and risky behaviors, increased substance use, and impulsivity and anger control problems since deployment. Almost all Veterans expressed interest in receiving services to help readjust to civilian life, and receiving reintegration services at a VA facility was reported as the preferred way to receive help. Mental health and anger problems are often cited as driving Veterans' difficulties readjusting to civilian life. Anger is becoming more widely recognized for its involvement in the psychological adjustment problems of post-9/11 Veterans. Research has shown that anger directly influences treatment outcome. In fact, history of untreated PTSD and aggression have been demonstrated to be pervasive among post-9/11 Veterans who die by suicide in the months before death. Veterans with probable PTSD report more reintegration and anger problems, and greater interest in services than Veterans without. Reintegration and anger problems continue for years post-combat and may not resolve without intervention. Research on TBI in post-9/11 Veterans underscores the need for programs that utilize an interdisciplinary approach to reintegration. Programs designed to address challenges of Veterans as they reintegrate in vocational environments, particularly integrative approaches, are greatly needed. The STEP-Home intervention provides such a program. STEP-Home includes focused cognitive and emotional regulation skills training and is informed by the most recent research with returning Veterans and available programs focused on reintegration in VA and military settings (e.g., Battlemind training). Phase 1: Years 1 and 2 The investigators will initiate the study at the Boston VAMC and develop Standard Operating Procedures for the addition of site 2 in Phase 2. Phase 2: Years 3 and 4 The investigators will initiate the study at the second site, the Houston VAMC, in Year 3. The investigators will apply in Year 2 for IRB approval to initiate site 2. Hypotheses & Aims Primary Aim 1. Examine treatment effects of STEP-Home on primary outcomes relative to Present Centered Group Therapy (PCGT): Hypothesis 1A. Participants randomized into the STEP-Home intervention will show improvement on reintegration, readjustment, and anger post-intervention (expressed by lower scores; less difficulty). Military to Civilian Questionnaire (M2CQ), Post-Deployment Readjustment Inventory (PDRI), and State-Trait Anger Expression Inventory (STAXI-2) scores post-intervention (T4) \< baseline (T1) Hypothesis 1B. Participants randomized into STEP-Home will show greater improvement in primary outcomes as compared to PCGT. Change scores baseline (T1) to post-intervention (T4) STEP-Home \> PCGT change scores Post-intervention (T4) primary outcome scores STEP-Home \< PCGT primary outcome scores (T4) Primary Aim 2. Examine maintenance of treatment effects on primary outcomes: Hypothesis 2: Treatment effects will be maintained at follow up in both groups. Differential treatment effect of STEP-Home over PCGT post-intervention (T4) will be maintained at follow up (T5). Exploratory Aim 1. Explore treatment effects of STEP-Home on measures of mental health, functional and vocational status and cognitive secondary outcomes targeted indirectly in the workshop. Exploratory Hypothesis 1. Acquisition of core skills (problem solving, emotional regulation, attention training) will mediate the effect of treatment on primary outcomes post-intervention and at follow up. The successful completion of the aims proposed has the potential to significantly improve skills to foster civilian reintegration in post-9/11Veterans. Furthermore, the STEP-Home SPiRE feasibility study demonstrated that the workshop also serves as a gateway for Veterans who are hesitant to participate in traditional mental health treatments to promote openness and engagement in additional, critically needed, VA services. Given the high rate of treatment resistance in this cohort, developing acceptable interventions that promote treatment engagement and retention, and open the door to future VA care, is necessary to improve functional status and to reduce long-term healthcare costs of untreated mental health illnesses.
Interventions
BEHAVIORALSTEP-Home
This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
BEHAVIORALPCGT
The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Assessments are all self-report, therefore, blinded assessors are not required.
Intervention model description
Participants will be randomly assigned to one of the two group interventions: STEP-Home or Present Centered Group Therapy (PCGT). Each cohort will include a minimum of 8 and a maximum of 20 participants who will be randomized to either STEP-Home (n = 4-10 Veterans) or PCGT (n = 4-10 Veterans). After inclusion and exclusion criteria are verified and a cohort of 8 to 20 is available, randomization into STEP-Home or PCGT occurs and participation in the study begins (i.e., Time 1; T1: Pre), during which the investigators will consent, administer the baseline assessments, randomly assign to the STEP-Home or PCGT arm, and schedule the treatment sessions. All participants will be assessed at the following outcome points: Screening, at randomization (T1), during treatment 4-week skills check (T2), during treatment 8-week skills check (T3), post-intervention (T4), and at 3-months follow up (T5).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Post-9/11 Veterans who report some reintegration, readjustment, or anger difficulty * i.e., Veterans who report some difficulty (Likert rating) on at least one of the primary measures: M2CQ; PDRI; STAXI-2 * 18-75 years old (to avoid outcomes being affected by aging) * English-speaking (sessions will be conducted in English) * Agreeing to participate * i.e., completion of ICF/HIPAA
Exclusion criteria
* schizophreniform disorder/active psychosis * bipolar disorder * active suicidality/homicidality requiring crisis intervention * other severe psychiatric disorders prohibiting appropriate group participation * neurological diagnosis prohibiting appropriate group participation (excluding TBI) * current substance dependence * current participation in any other form of active behavioral therapy at the time of enrollment * e.g., Cognitive Processing Therapy, cognitive rehabilitation for mTBI, or other psychotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Military to Civilian Questionnaire | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A 16-item measure of post-deployment community reintegration in post-9/11 Veterans. Higher scores indicate greater reintegration and functional difficulties. Min: 0, Max: 64 |
| Post-deployment Readjustment Inventory (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A 36-item measure of readjustment in post-9/11 Veterans with six subscales (career challenges, social difficulties, intimate relationship problems, health concerns, concerns about deployment, and PTSD symptoms). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score is calculated by adding the value of all items in all subscales. Career: Min: 5, Max: 25 Health: Min: 5, Max: 25 Intimate Relationship: Min: 5, Max: 25 Social readjustment: Min: 7, Max: 35 Concerns about deployment: Min: 6, Max: 30 PTSD symptoms: Min: 8, Max: 40 TOTAL score: Min: 36, Max: 180 |
| State-Trait Anger Expression Inventory (STAXI-2) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A 57-item widely used measure to assess state anger, trait anger, and anger expression with three subscales (state anger, trait anger, and anger expression). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better. How I Feel Right Now (State Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale How I Generally Feel (Trait Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale When Angry or Furious (Anger expression index): Min: 24, Max: 96, Calculated by summing anger control scores for each item (12 items) and subtracting that from sum of anger expression scores for each item (12 items) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | Measure to assess multiple aspects of emotion dysregulation. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Nonacceptance of emotional responses: Min: 6, Max: 30 Difficulty engaging in goal-directed behavior: Min: 6, Max: 25 Impulse control difficulties: Min: 6, Max: 30 Lack of emotional awareness: Min: 6, Max: 30 Limited access to emotion regulation strategies: Min: 8, Max: 40 Lack of emotional clarity: Min: 5, Max: 25 TOTAL score: Min: 36, Max: 180, Total score calculated by adding the scores of all items (reverse scoring awareness items). |
| PTSD Checklist for DSM-5 (PCL-5) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A 20-item measure of PTSD updated for DSM-5. Min: 0, Max: 80 (lower scores are better) |
| Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A 22-item measure of current post-concussive symptoms. Total score Min: 0, Max: 88 (lower scores are better), calculated by adding the scores of all of the subscales. Vestibular Min: 0, Max: 12 (3 items) Somatosensory Min: 0, Max: 20 (5 items) Affective Min: 0, Max: 24 (6 items) Cognitive Min: 0, Max: 32 (8 items) |
| World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | Measures functional states in six domains (understanding and communicating, getting around, self care, getting along with people, life activities (work/school), and participation in society). Possible raw min and max scores are below. For all subscales and total score, data is presented as a computed score in a range from 0-100. This is calculated by taking the raw score for each subscale and total score, dividing it by number of possible points for the relevant questions, and multiplying it by 100. Lower scores are better. Understanding and Communicating: Min: 0, Max: 24 Getting Around: Min: 0, Max: 20 Self Care: Min: 0, Max: 16 Getting Along with People: Min: 0, Max: 20 Life Activities: Min: 0, Max: 16 Work-School: Min: 0, Max: 16 Participation: Min: 0, Max: 32 Total Aggregate: Min: 0, Max: 144 |
| Attention-Related Cognitive Errors Scale (ARCES) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | Measure of everyday performance failures arising from brief failures of sustained attention. Min: 12, Max: 60 (lower scores are better) |
| Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | Assesses engagement in school, work, and life activities. Participants self reported engagement in each category at each time point. Categories are not mutually exclusive, but rather indicate how many participants endorsed participating in each category at each time point. A scale is not used in this measure. |
| Barriers to Employment Success Inventory (BESI) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A measure of obstacles to employment in five areas (Personal/Financial, Emotional/Physical, Career Decision-Making and Planning, Job-Seeking Knowledge, and Training/Education). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Only total score analyzed, subscales not reported. Personal and Financial: Min: 10, Max: 40 Emotional and Physical: Min: 10, Max: 40 Career Decision-Making and Planning: Min: 10, Max: 40 Job-Seeking Knowledge: Min: 10, Max: 40 Training and Education: Min: 10, Max: 40 TOTAL score: Min: 50, Max: 200 |
| Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | Change in average number of hours worked per month over time. Participants self-reported average number of hours worked in the month before STEP-Home (baseline), in each month of the intervention/PCGT (measured at post-treatment), and post-treatment monitoring (follow-up). A scale is not used in this measure. Each row indicates the number of participants that worked the indicated number of hours at each time point. Rows are mutually exclusive. |
| Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | Measures apathy, disinhibition, and executive dysfunction. Min and max possible scores for subscales and total score are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Subscale scores calculated by adding the scores of the items in each subscale. Apathy Min: 14, Max: 70 Disinhibition Min: 15, Max: 75 Executive Dysfunction Min: 17, Max: 85 Total Score Min: 46, Max: 230 |
| Satisfaction With Life Scale (SWLS) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A 5-item measure of satisfaction with life. Min: 5, Max: 35 (higher scores are better) |
| Problem Solving Inventory (PSI) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | Measure of problem solving confidence, approach-avoidance style, and personal control. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Problem-Solving Confidence: Min: 11, Max: 66 Approach-Avoidance Style: Min: 16, Max: 96 Personal Control: Min: 5, Max: 30 TOTAL score: Min: 32, Max: 192 |
| Depression Anxiety and Stress Scale (DASS-21) (Change) | Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up) | A 21-item measure of current depression, anxiety, and stress. Each subscale Min: 7, Max: 28 (lower scores are better) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from VA clinical services, community partners (e.g., schools, Vet Centers, Veteran organizations), advertisements on social media (e.g., Facebook, Instagram), and the Veterans Affairs/Department of Defense Identity Repository.
Pre-assignment details
195 (138M/57F) post-9/11 U.S. military Veterans were randomized to either 12 sessions of SH or PCGT. Assessments were conducted at baseline, 12 and 24 weeks. Analyses were based on intention to treat.
Participants by arm
| Arm | Count |
|---|---|
| STEP-Home The STEP-Home Arm involves a skills-based intervention focused on Emotional Regulation, Problem Solving, and Attention Training strategies.
STEP-Home: This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions. | 93 |
| PCGT The Present Center Group Therapy (PCGT) Arm involves a nonspecific, supportive intervention, focused on identifying and discussing current life stressors.
PCGT: The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health. | 91 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-Up Assessment | Lost to Follow-up | 9 | 12 |
| Intervention & Post-Treatment Assessment | Did not start treatment | 18 | 16 |
| Intervention & Post-Treatment Assessment | Lost to Follow-up | 3 | 1 |
| Intervention & Post-Treatment Assessment | Physician Decision | 1 | 4 |
| Intervention & Post-Treatment Assessment | Withdrawal by Subject | 25 | 17 |
Baseline characteristics
| Characteristic | Total | PCGT | STEP-Home |
|---|---|---|---|
| Age, Continuous | 39.1 Years STANDARD_DEVIATION 10.4 | 39.8 Years STANDARD_DEVIATION 10.5 | 38.2 Years STANDARD_DEVIATION 10.3 |
| Branch of Service Air Force | 14 Participants | 9 Participants | 5 Participants |
| Branch of Service Army | 98 Participants | 43 Participants | 55 Participants |
| Branch of Service Coast Guard | 3 Participants | 0 Participants | 3 Participants |
| Branch of Service Marines | 21 Participants | 10 Participants | 11 Participants |
| Branch of Service Missing Data | 15 Participants | 9 Participants | 6 Participants |
| Branch of Service Multiple Branches | 11 Participants | 8 Participants | 3 Participants |
| Branch of Service Navy | 22 Participants | 12 Participants | 10 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 8 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 40 Participants | 21 Participants | 19 Participants |
| Race/Ethnicity, Customized Hispanic | 45 Participants | 22 Participants | 23 Participants |
| Race/Ethnicity, Customized Other | 22 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 122 Participants | 60 Participants | 62 Participants |
| Sex: Female, Male Female | 45 Participants | 20 Participants | 25 Participants |
| Sex: Female, Male Male | 139 Participants | 71 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 95 |
| other Total, other adverse events | 0 / 100 | 0 / 95 |
| serious Total, serious adverse events | 0 / 100 | 0 / 95 |
Outcome results
Primary
Military to Civilian Questionnaire
A 16-item measure of post-deployment community reintegration in post-9/11 Veterans. Higher scores indicate greater reintegration and functional difficulties. Min: 0, Max: 64
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Military to Civilian Questionnaire | Baseline | 33.8 score on a scale | Standard Deviation 13.2 |
| STEP-Home | Military to Civilian Questionnaire | Post-Intervention | 25.5 score on a scale | Standard Deviation 15.3 |
| STEP-Home | Military to Civilian Questionnaire | Follow-Up | 24.4 score on a scale | Standard Deviation 15.5 |
| PCGT | Military to Civilian Questionnaire | Baseline | 34.7 score on a scale | Standard Deviation 11.5 |
| PCGT | Military to Civilian Questionnaire | Post-Intervention | 27.1 score on a scale | Standard Deviation 11.2 |
| PCGT | Military to Civilian Questionnaire | Follow-Up | 27.7 score on a scale | Standard Deviation 11 |
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: <0.0001t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: <0.0001t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: <0.0001t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: <0.0001t-test, 2 sided
Primary
Post-deployment Readjustment Inventory (Change)
A 36-item measure of readjustment in post-9/11 Veterans with six subscales (career challenges, social difficulties, intimate relationship problems, health concerns, concerns about deployment, and PTSD symptoms). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score is calculated by adding the value of all items in all subscales. Career: Min: 5, Max: 25 Health: Min: 5, Max: 25 Intimate Relationship: Min: 5, Max: 25 Social readjustment: Min: 7, Max: 35 Concerns about deployment: Min: 6, Max: 30 PTSD symptoms: Min: 8, Max: 40 TOTAL score: Min: 36, Max: 180
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Baseline Career Challenges | 15.5 score on a scale | Standard Deviation 5.7 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Post-Treatment Total Score | 107.8 score on a scale | Standard Deviation 35.8 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Follow-Up Total Score | 100.0 score on a scale | Standard Deviation 37.9 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Post-Treatment Career Challenges | 13.9 score on a scale | Standard Deviation 5.2 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Follow-Up Career Challenges | 12.8 score on a scale | Standard Deviation 5.8 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Baseline Health Concerns | 17.0 score on a scale | Standard Deviation 5.7 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Post-Treatment Health Concerns | 15.7 score on a scale | Standard Deviation 5.6 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Follow-Up Health Concerns | 14.4 score on a scale | Standard Deviation 5.7 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Baseline Intimate Relationship Problems | 15.3 score on a scale | Standard Deviation 5.6 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Post-Treatment Intimate Relationship Problems | 14.2 score on a scale | Standard Deviation 5.6 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Follow-Up Intimate Relationship Problems | 13.3 score on a scale | Standard Deviation 5.6 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Baseline Social Readjustment | 23.5 score on a scale | Standard Deviation 7.3 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Post-Treatment Social Readjustment | 22.0 score on a scale | Standard Deviation 7.5 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Follow-Up Social Readjustment | 20.8 score on a scale | Standard Deviation 8.1 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Baseline Total Score | 117.1 score on a scale | Standard Deviation 32.6 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Baseline Concerns About Deployment | 16.8 score on a scale | Standard Deviation 6.2 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Post-Treatment Concerns About Deployment | 15.8 score on a scale | Standard Deviation 6.4 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Follow-Up Concerns About Deployment | 14.5 score on a scale | Standard Deviation 6.2 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Baseline PTSD Symptoms | 28.3 score on a scale | Standard Deviation 8.3 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Post-Treatment PTSD Symptoms | 26.2 score on a scale | Standard Deviation 9 |
| STEP-Home | Post-deployment Readjustment Inventory (Change) | Follow-Up PTSD Symptoms | 24.3 score on a scale | Standard Deviation 9.4 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Follow-Up Intimate Relationship Problems | 13.8 score on a scale | Standard Deviation 4.5 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Baseline Total Score | 121.0 score on a scale | Standard Deviation 26.9 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Follow-Up Concerns About Deployment | 15.6 score on a scale | Standard Deviation 5.5 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Post-Treatment Total Score | 116.2 score on a scale | Standard Deviation 27.4 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Baseline Social Readjustment | 24.5 score on a scale | Standard Deviation 5.9 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Baseline Career Challenges | 16.6 score on a scale | Standard Deviation 4.5 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Post-Treatment PTSD Symptoms | 28.1 score on a scale | Standard Deviation 6.5 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Post-Treatment Career Challenges | 15.5 score on a scale | Standard Deviation 4.7 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Post-Treatment Social Readjustment | 23.8 score on a scale | Standard Deviation 5.9 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Follow-Up Career Challenges | 14.8 score on a scale | Standard Deviation 4.4 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Post-Treatment Concerns About Deployment | 16.6 score on a scale | Standard Deviation 5.3 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Baseline Health Concerns | 18.0 score on a scale | Standard Deviation 4.7 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Follow-Up Social Readjustment | 21.8 score on a scale | Standard Deviation 6 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Post-Treatment Health Concerns | 17.3 score on a scale | Standard Deviation 4.9 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Baseline Concerns About Deployment | 17.5 score on a scale | Standard Deviation 5.8 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Follow-Up Health Concerns | 17.4 score on a scale | Standard Deviation 5 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Follow-Up PTSD Symptoms | 27.7 score on a scale | Standard Deviation 6.8 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Baseline Intimate Relationship Problems | 16.0 score on a scale | Standard Deviation 5.1 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Follow-Up Total Score | 111.1 score on a scale | Standard Deviation 27.5 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Post-Treatment Intimate Relationship Problems | 14.8 score on a scale | Standard Deviation 4.6 |
| PCGT | Post-deployment Readjustment Inventory (Change) | Baseline PTSD Symptoms | 30.0 score on a scale | Standard Deviation 6.6 |
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only.p-value: 0.0044t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only.p-value: <0.0001t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only.p-value: 0.0162t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only.p-value: 0.0009t-test, 2 sided
Primary
State-Trait Anger Expression Inventory (STAXI-2) (Change)
A 57-item widely used measure to assess state anger, trait anger, and anger expression with three subscales (state anger, trait anger, and anger expression). Min and max scores for the subscales, and the total score, are below. For all, lower scores are better. How I Feel Right Now (State Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale How I Generally Feel (Trait Anger): Min: 10, Max: 40, Calculated by summing 15 items in scale When Angry or Furious (Anger expression index): Min: 24, Max: 96, Calculated by summing anger control scores for each item (12 items) and subtracting that from sum of anger expression scores for each item (12 items)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Baseline State Anger | 25.8 score on a scale | Standard Deviation 11.2 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Post-Treatment State Anger | 22.8 score on a scale | Standard Deviation 9 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Post-Treatment Trait Anger | 19.9 score on a scale | Standard Deviation 7.1 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Post-Treatment Anger Index | 40.2 score on a scale | Standard Deviation 13 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Follow-Up State Anger | 21.7 score on a scale | Standard Deviation 10 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Baseline Trait Anger | 21.9 score on a scale | Standard Deviation 6.7 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Baseline Anger Index | 43.1 score on a scale | Standard Deviation 14.4 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Follow-Up Trait Anger | 19.3 score on a scale | Standard Deviation 6.1 |
| STEP-Home | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Follow-Up Anger Index | 37.7 score on a scale | Standard Deviation 12.9 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Post-Treatment Trait Anger | 20.6 score on a scale | Standard Deviation 7 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Baseline State Anger | 26.2 score on a scale | Standard Deviation 9.2 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Baseline Trait Anger | 21.6 score on a scale | Standard Deviation 6.2 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Baseline Anger Index | 42.0 score on a scale | Standard Deviation 12.9 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Follow-Up State Anger | 21.9 score on a scale | Standard Deviation 7.3 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Post-Treatment State Anger | 21.4 score on a scale | Standard Deviation 7.3 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Follow-Up Anger Index | 39.2 score on a scale | Standard Deviation 14.5 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Follow-Up Trait Anger | 18.5 score on a scale | Standard Deviation 6.7 |
| PCGT | State-Trait Anger Expression Inventory (STAXI-2) (Change) | Post-Treatment Anger Index | 41.9 score on a scale | Standard Deviation 14.7 |
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.014t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.1548t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.0302t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.0158t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.0034t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.8776t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.0002t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.0198t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.0013t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: <0.0001t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.0345t-test, 2 sided
Comparison: Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groupsp-value: 0.5918t-test, 2 sided
Secondary
Attention-Related Cognitive Errors Scale (ARCES) (Change)
Measure of everyday performance failures arising from brief failures of sustained attention. Min: 12, Max: 60 (lower scores are better)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Attention-Related Cognitive Errors Scale (ARCES) (Change) | Baseline | 41.9 score on a scale | Standard Deviation 12.4 |
| STEP-Home | Attention-Related Cognitive Errors Scale (ARCES) (Change) | Follow-Up | 37.7 score on a scale | Standard Deviation 14.1 |
| STEP-Home | Attention-Related Cognitive Errors Scale (ARCES) (Change) | Post-Treatment | 38.2 score on a scale | Standard Deviation 12.7 |
| PCGT | Attention-Related Cognitive Errors Scale (ARCES) (Change) | Baseline | 42.7 score on a scale | Standard Deviation 9.9 |
| PCGT | Attention-Related Cognitive Errors Scale (ARCES) (Change) | Follow-Up | 39.0 score on a scale | Standard Deviation 11.7 |
| PCGT | Attention-Related Cognitive Errors Scale (ARCES) (Change) | Post-Treatment | 39.6 score on a scale | Standard Deviation 12.9 |
Secondary
Barriers to Employment Success Inventory (BESI) (Change)
A measure of obstacles to employment in five areas (Personal/Financial, Emotional/Physical, Career Decision-Making and Planning, Job-Seeking Knowledge, and Training/Education). Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Only total score analyzed, subscales not reported. Personal and Financial: Min: 10, Max: 40 Emotional and Physical: Min: 10, Max: 40 Career Decision-Making and Planning: Min: 10, Max: 40 Job-Seeking Knowledge: Min: 10, Max: 40 Training and Education: Min: 10, Max: 40 TOTAL score: Min: 50, Max: 200
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Barriers to Employment Success Inventory (BESI) (Change) | Baseline Total Score | 103.5 score on a scale | Standard Deviation 33.9 |
| STEP-Home | Barriers to Employment Success Inventory (BESI) (Change) | Post-Treatment Total Score | 90.7 score on a scale | Standard Deviation 33.9 |
| STEP-Home | Barriers to Employment Success Inventory (BESI) (Change) | Follow-Up Total Score | 89.0 score on a scale | Standard Deviation 35.9 |
| PCGT | Barriers to Employment Success Inventory (BESI) (Change) | Baseline Total Score | 101.8 score on a scale | Standard Deviation 32.9 |
| PCGT | Barriers to Employment Success Inventory (BESI) (Change) | Post-Treatment Total Score | 96.3 score on a scale | Standard Deviation 32.1 |
| PCGT | Barriers to Employment Success Inventory (BESI) (Change) | Follow-Up Total Score | 88.3 score on a scale | Standard Deviation 32.6 |
Secondary
Depression Anxiety and Stress Scale (DASS-21) (Change)
A 21-item measure of current depression, anxiety, and stress. Each subscale Min: 7, Max: 28 (lower scores are better)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Follow-Up Anxiety | 11.1 score on a scale | Standard Deviation 10.6 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Follow-Up Stress | 15.6 score on a scale | Standard Deviation 10.4 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Post-Intervention Depression | 16.0 score on a scale | Standard Deviation 13.1 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Baseline Anxiety | 15.4 score on a scale | Standard Deviation 11.6 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Post-Intervention Anxiety | 12.7 score on a scale | Standard Deviation 11.2 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Baseline Depression | 18.7 score on a scale | Standard Deviation 12.3 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Post-Intervention Stress | 17.1 score on a scale | Standard Deviation 11.6 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Follow-Up Depression | 12.7 score on a scale | Standard Deviation 11.4 |
| STEP-Home | Depression Anxiety and Stress Scale (DASS-21) (Change) | Baseline Stress | 20.7 score on a scale | Standard Deviation 10.9 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Follow-Up Depression | 16.3 score on a scale | Standard Deviation 10 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Baseline Stress | 20.9 score on a scale | Standard Deviation 9 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Post-Intervention Anxiety | 12.8 score on a scale | Standard Deviation 9.6 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Post-Intervention Depression | 15.7 score on a scale | Standard Deviation 10.6 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Post-Intervention Stress | 18.9 score on a scale | Standard Deviation 9.4 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Follow-Up Stress | 18.8 score on a scale | Standard Deviation 8.8 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Baseline Anxiety | 14.6 score on a scale | Standard Deviation 10 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Follow-Up Anxiety | 12.8 score on a scale | Standard Deviation 10.2 |
| PCGT | Depression Anxiety and Stress Scale (DASS-21) (Change) | Baseline Depression | 19.0 score on a scale | Standard Deviation 10.5 |
Secondary
Difficulties in Emotion Regulation Scale (DERS) (Change)
Measure to assess multiple aspects of emotion dysregulation. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Nonacceptance of emotional responses: Min: 6, Max: 30 Difficulty engaging in goal-directed behavior: Min: 6, Max: 25 Impulse control difficulties: Min: 6, Max: 30 Lack of emotional awareness: Min: 6, Max: 30 Limited access to emotion regulation strategies: Min: 8, Max: 40 Lack of emotional clarity: Min: 5, Max: 25 TOTAL score: Min: 36, Max: 180, Total score calculated by adding the scores of all items (reverse scoring awareness items).
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Clarity | 12.0 score on a scale | Standard Deviation 5.1 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Clarity | 12.1 score on a scale | Standard Deviation 4.7 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Total Score | 90.8 score on a scale | Standard Deviation 26.1 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Total Score | 89.2 score on a scale | Standard Deviation 30 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Non-Acceptance | 14.7 score on a scale | Standard Deviation 7.4 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Goals | 17.4 score on a scale | Standard Deviation 4.9 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Goals | 15.5 score on a scale | Standard Deviation 5.6 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Goals | 14.7 score on a scale | Standard Deviation 6.1 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Impulse | 15.3 score on a scale | Standard Deviation 5.1 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Strategies | 19.0 score on a scale | Standard Deviation 8.5 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Clarity | 13.7 score on a scale | Standard Deviation 4.7 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Total Score | 104.2 score on a scale | Standard Deviation 26 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Non-Acceptance | 16.1 score on a scale | Standard Deviation 7.4 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Non-Acceptance | 15.0 score on a scale | Standard Deviation 6.6 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Impulse | 13.1 score on a scale | Standard Deviation 4.4 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Impulse | 12.2 score on a scale | Standard Deviation 5 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Awareness | 17.2 score on a scale | Standard Deviation 5.6 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Awareness | 16.2 score on a scale | Standard Deviation 5.8 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Awareness | 16.5 score on a scale | Standard Deviation 6.5 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Strategies | 23.3 score on a scale | Standard Deviation 8.4 |
| STEP-Home | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Strategies | 19.0 score on a scale | Standard Deviation 8 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Non-Acceptance | 18.0 score on a scale | Standard Deviation 6.5 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Strategies | 19.5 score on a scale | Standard Deviation 7.4 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Clarity | 13.0 score on a scale | Standard Deviation 4.3 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Total Score | 106.9 score on a scale | Standard Deviation 24.3 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Non-Acceptance | 16.2 score on a scale | Standard Deviation 5.9 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Goals | 15.9 score on a scale | Standard Deviation 5.2 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Impulse | 15.0 score on a scale | Standard Deviation 6.3 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Non-Acceptance | 16.1 score on a scale | Standard Deviation 7.4 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Awareness | 17.4 score on a scale | Standard Deviation 5.6 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Goals | 17.7 score on a scale | Standard Deviation 5.4 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Impulse | 13.5 score on a scale | Standard Deviation 5.7 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Goals | 16.6 score on a scale | Standard Deviation 5.6 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Clarity | 14.8 score on a scale | Standard Deviation 3.5 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Impulse | 12.5 score on a scale | Standard Deviation 4.8 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Strategies | 20.2 score on a scale | Standard Deviation 7.4 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Strategies | 22.6 score on a scale | Standard Deviation 7.4 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Baseline Awareness | 19.0 score on a scale | Standard Deviation 4.9 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Clarity | 13.4 score on a scale | Standard Deviation 4 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Total Score | 97.6 score on a scale | Standard Deviation 25.8 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Follow-Up Total Score | 94.0 score on a scale | Standard Deviation 26.4 |
| PCGT | Difficulties in Emotion Regulation Scale (DERS) (Change) | Post-Treatment Awareness | 17.8 score on a scale | Standard Deviation 5.7 |
Secondary
Frontal Systems Behavior Scale (FrSBe) (Change)
Measures apathy, disinhibition, and executive dysfunction. Min and max possible scores for subscales and total score are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Subscale scores calculated by adding the scores of the items in each subscale. Apathy Min: 14, Max: 70 Disinhibition Min: 15, Max: 75 Executive Dysfunction Min: 17, Max: 85 Total Score Min: 46, Max: 230
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Total Score | 109.2 score on a scale | Standard Deviation 23.7 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Disinhibition | 33.2 score on a scale | Standard Deviation 9.6 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Apathy | 36.2 score on a scale | Standard Deviation 9.8 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Disinhibition | 32.3 score on a scale | Standard Deviation 9.6 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Total Score | 111.8 score on a scale | Standard Deviation 25.6 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Executive Dysfunction | 45.6 score on a scale | Standard Deviation 9 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Apathy | 35.8 score on a scale | Standard Deviation 8.8 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Executive Dysfunction | 42.4 score on a scale | Standard Deviation 8.7 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Apathy | 41.1 score on a scale | Standard Deviation 9.8 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Executive Dysfunction | 41.1 score on a scale | Standard Deviation 7.8 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Disinhibition | 37.6 score on a scale | Standard Deviation 10.4 |
| STEP-Home | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Total Score | 124.8 score on a scale | Standard Deviation 25.9 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Total Score | 124.9 score on a scale | Standard Deviation 25.8 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Total Score | 111.9 score on a scale | Standard Deviation 25 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Total Score | 110.2 score on a scale | Standard Deviation 26.1 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Apathy | 43.2 score on a scale | Standard Deviation 9.4 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Apathy | 38.3 score on a scale | Standard Deviation 10.2 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Apathy | 41.8 score on a scale | Standard Deviation 9.3 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Disinhibition | 37.0 score on a scale | Standard Deviation 8.4 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Disinhibition | 31.8 score on a scale | Standard Deviation 9.6 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Disinhibition | 31.1 score on a scale | Standard Deviation 10.3 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Baseline Executive Dysfunction | 46.5 score on a scale | Standard Deviation 8.1 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Post-Treatment Executive Dysfunction | 41.8 score on a scale | Standard Deviation 9.3 |
| PCGT | Frontal Systems Behavior Scale (FrSBe) (Change) | Follow-Up Executive Dysfunction | 41.8 score on a scale | Standard Deviation 9.3 |
Secondary
Neurobehavioral Symptoms Inventory (NSI) (Change)
A 22-item measure of current post-concussive symptoms. Total score Min: 0, Max: 88 (lower scores are better), calculated by adding the scores of all of the subscales. Vestibular Min: 0, Max: 12 (3 items) Somatosensory Min: 0, Max: 20 (5 items) Affective Min: 0, Max: 24 (6 items) Cognitive Min: 0, Max: 32 (8 items)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Total Score | 39.2 score on a scale | Standard Deviation 19.7 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Intervention Total Score | 30.5 score on a scale | Standard Deviation 19.5 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Total Score | 27.9 score on a scale | Standard Deviation 19.1 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Vestibular | 2.7 score on a scale | Standard Deviation 2.9 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Somatic | 8.1 score on a scale | Standard Deviation 6.6 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Somatic | 6.6 score on a scale | Standard Deviation 6.1 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Somatic | 7.0 score on a scale | Standard Deviation 6.3 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Cognitive | 9.0 score on a scale | Standard Deviation 4 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Cognitive | 7.6 score on a scale | Standard Deviation 4.9 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Affective | 14.2 score on a scale | Standard Deviation 6.3 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Affective | 11.5 score on a scale | Standard Deviation 6.8 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Affective | 9.4 score on a scale | Standard Deviation 6.1 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Vestibular | 3.3 score on a scale | Standard Deviation 3.2 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Vestibular | 2.5 score on a scale | Standard Deviation 2.6 |
| STEP-Home | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Cognitive | 6.6 score on a scale | Standard Deviation 4.2 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Affective | 13.4 score on a scale | Standard Deviation 5.3 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Total Score | 39.0 score on a scale | Standard Deviation 16.7 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Cognitive | 9.4 score on a scale | Standard Deviation 4.2 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Intervention Total Score | 35.0 score on a scale | Standard Deviation 17.9 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Affective | 12.2 score on a scale | Standard Deviation 5.7 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Total Score | 36.3 score on a scale | Standard Deviation 17.4 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Vestibular | 3.3 score on a scale | Standard Deviation 2.8 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Cognitive | 7.7 score on a scale | Standard Deviation 4.2 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Vestibular | 4.2 score on a scale | Standard Deviation 3.2 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Cognitive | 8.0 score on a scale | Standard Deviation 4.8 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Somatic | 9.0 score on a scale | Standard Deviation 5.5 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Baseline Vestibular | 3.3 score on a scale | Standard Deviation 2.9 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Somatic | 8.4 score on a scale | Standard Deviation 5.6 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Post-Treatment Affective | 12.3 score on a scale | Standard Deviation 5.6 |
| PCGT | Neurobehavioral Symptoms Inventory (NSI) (Change) | Follow-Up Somatic | 9.2 score on a scale | Standard Deviation 5.7 |
Secondary
Number of Participants Differing in Activity Engagement Over Time (Change)
Assesses engagement in school, work, and life activities. Participants self reported engagement in each category at each time point. Categories are not mutually exclusive, but rather indicate how many participants endorsed participating in each category at each time point. A scale is not used in this measure.
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Work | 42 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline School/Training Programs | 18 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Volunteer Activities | 15 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Veteran-Oriented Programs | 29 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Community Activities | 17 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Socializing | 50 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Work | 22 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention School/Training Programs | 14 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Volunteer Activities | 17 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Veteran-Oriented Programs | 27 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Community Activities | 12 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Socializing | 34 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Work | 18 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up School/Training Programs | 8 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Volunteer Activities | 11 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Veteran-Oriented Programs | 15 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Community Activities | 14 Participants |
| STEP-Home | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Socializing | 26 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up School/Training Programs | 16 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Work | 37 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Veteran-Oriented Programs | 20 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline School/Training Programs | 26 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Socializing | 25 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Volunteer Activities | 19 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Community Activities | 13 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Veteran-Oriented Programs | 17 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Volunteer Activities | 11 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Community Activities | 12 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Socializing | 37 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Baseline Socializing | 46 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Community Activities | 8 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Work | 20 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Work | 22 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention School/Training Programs | 19 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Follow-Up Veteran-Oriented Programs | 11 Participants |
| PCGT | Number of Participants Differing in Activity Engagement Over Time (Change) | Post-Intervention Volunteer Activities | 14 Participants |
Secondary
Number of Participants Differing in Average Number of Hours Worked (Change)
Change in average number of hours worked per month over time. Participants self-reported average number of hours worked in the month before STEP-Home (baseline), in each month of the intervention/PCGT (measured at post-treatment), and post-treatment monitoring (follow-up). A scale is not used in this measure. Each row indicates the number of participants that worked the indicated number of hours at each time point. Rows are mutually exclusive.
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline >40 hours/week | 20 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 31-40 hours/week | 5 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 21-30 hours/week | 5 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention >40 hours/week | 15 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention <1 hour/week | 33 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up <1 hour/week | 26 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 11-20 hours/week | 3 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 1-10 hours/week | 2 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 1-10 hours/week | 0 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 11-20 hours/week | 2 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 31-40 hours/week | 9 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 21-30 hours/week | 0 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 11-20 hours/week | 0 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 1-10 hours/week | 4 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up >40 hours/week | 9 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 21-30 hours/week | 2 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline <1 hour | 53 Participants |
| STEP-Home | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 31-40 hours/week | 5 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 21-30 hours/week | 2 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 1-10 hours/week | 4 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 11-20 hours/week | 6 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 21-30 hours/week | 3 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline 31-40 hours/week | 10 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline >40 hours/week | 10 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention <1 hour/week | 37 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 1-10 hours/week | 3 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 11-20 hours/week | 4 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Baseline <1 hour | 55 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention 31-40 hours/week | 6 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Post-Intervention >40 hours/week | 5 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up <1 hour/week | 23 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 1-10 hours/week | 2 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 11-20 hours/week | 5 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 21-30 hours/week | 2 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up 31-40 hours/week | 8 Participants |
| PCGT | Number of Participants Differing in Average Number of Hours Worked (Change) | Follow-Up >40 hours/week | 5 Participants |
Secondary
Problem Solving Inventory (PSI) (Change)
Measure of problem solving confidence, approach-avoidance style, and personal control. Min and max scores for all the subscales, and the total score, are below. For all, lower scores are better. Total score calculated by adding the scores of all items. Problem-Solving Confidence: Min: 11, Max: 66 Approach-Avoidance Style: Min: 16, Max: 96 Personal Control: Min: 5, Max: 30 TOTAL score: Min: 32, Max: 192
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Baseline Total Score | 100.6 score on a scale | Standard Deviation 21.9 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Follow-Up Total Score | 94.3 score on a scale | Standard Deviation 24 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Baseline Problem Solving | 31.7 score on a scale | Standard Deviation 8.5 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Post-Treatment Problem Solving | 27.3 score on a scale | Standard Deviation 9 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Baseline Approach Avoidance | 49.4 score on a scale | Standard Deviation 13.4 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Follow-Up Approach Avoidance | 47.2 score on a scale | Standard Deviation 11.7 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Baseline Personal Control | 20.3 score on a scale | Standard Deviation 5.6 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Post-Treatment Total Score | 93.1 score on a scale | Standard Deviation 22 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Follow-Up Problem Solving | 28.2 score on a scale | Standard Deviation 10.6 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Post-Treatment Approach Avoidance | 47.4 score on a scale | Standard Deviation 11.2 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Post-Treatment Personal Control | 18.4 score on a scale | Standard Deviation 4.8 |
| STEP-Home | Problem Solving Inventory (PSI) (Change) | Follow-Up Personal Control | 19.0 score on a scale | Standard Deviation 5 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Baseline Approach Avoidance | 51.8 score on a scale | Standard Deviation 13.3 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Baseline Personal Control | 21.2 score on a scale | Standard Deviation 4.8 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Follow-Up Total Score | 95.3 score on a scale | Standard Deviation 24.2 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Baseline Total Score | 102.6 score on a scale | Standard Deviation 21.7 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Baseline Problem Solving | 31.5 score on a scale | Standard Deviation 9.1 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Post-Treatment Personal Control | 18.6 score on a scale | Standard Deviation 5.6 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Post-Treatment Problem Solving | 31.5 score on a scale | Standard Deviation 9.1 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Follow-Up Problem Solving | 28.8 score on a scale | Standard Deviation 9.6 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Post-Treatment Total Score | 94.1 score on a scale | Standard Deviation 26.7 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Post-Treatment Approach Avoidance | 47.6 score on a scale | Standard Deviation 15.5 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Follow-Up Personal Control | 19.0 score on a scale | Standard Deviation 4.4 |
| PCGT | Problem Solving Inventory (PSI) (Change) | Follow-Up Approach Avoidance | 47.6 score on a scale | Standard Deviation 14.2 |
Secondary
PTSD Checklist for DSM-5 (PCL-5) (Change)
A 20-item measure of PTSD updated for DSM-5. Min: 0, Max: 80 (lower scores are better)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | PTSD Checklist for DSM-5 (PCL-5) (Change) | Baseline | 43.5 score on a scale | Standard Deviation 20.1 |
| STEP-Home | PTSD Checklist for DSM-5 (PCL-5) (Change) | Post-Intervention | 36.3 score on a scale | Standard Deviation 20.7 |
| STEP-Home | PTSD Checklist for DSM-5 (PCL-5) (Change) | Follow-Up | 34.9 score on a scale | Standard Deviation 21.6 |
| PCGT | PTSD Checklist for DSM-5 (PCL-5) (Change) | Baseline | 44.9 score on a scale | Standard Deviation 17.7 |
| PCGT | PTSD Checklist for DSM-5 (PCL-5) (Change) | Post-Intervention | 39.6 score on a scale | Standard Deviation 19.4 |
| PCGT | PTSD Checklist for DSM-5 (PCL-5) (Change) | Follow-Up | 41.0 score on a scale | Standard Deviation 20.6 |
Secondary
Satisfaction With Life Scale (SWLS) (Change)
A 5-item measure of satisfaction with life. Min: 5, Max: 35 (higher scores are better)
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | Satisfaction With Life Scale (SWLS) (Change) | Baseline | 15.1 score on a scale | Standard Deviation 7.1 |
| STEP-Home | Satisfaction With Life Scale (SWLS) (Change) | Post-Treatment | 18.0 score on a scale | Standard Deviation 7.6 |
| STEP-Home | Satisfaction With Life Scale (SWLS) (Change) | Follow-Up | 17.8 score on a scale | Standard Deviation 8.9 |
| PCGT | Satisfaction With Life Scale (SWLS) (Change) | Baseline | 15.3 score on a scale | Standard Deviation 7.5 |
| PCGT | Satisfaction With Life Scale (SWLS) (Change) | Post-Treatment | 16.6 score on a scale | Standard Deviation 7.7 |
| PCGT | Satisfaction With Life Scale (SWLS) (Change) | Follow-Up | 17.7 score on a scale | Standard Deviation 7.8 |
Secondary
World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change)
Measures functional states in six domains (understanding and communicating, getting around, self care, getting along with people, life activities (work/school), and participation in society). Possible raw min and max scores are below. For all subscales and total score, data is presented as a computed score in a range from 0-100. This is calculated by taking the raw score for each subscale and total score, dividing it by number of possible points for the relevant questions, and multiplying it by 100. Lower scores are better. Understanding and Communicating: Min: 0, Max: 24 Getting Around: Min: 0, Max: 20 Self Care: Min: 0, Max: 16 Getting Along with People: Min: 0, Max: 20 Life Activities: Min: 0, Max: 16 Work-School: Min: 0, Max: 16 Participation: Min: 0, Max: 32 Total Aggregate: Min: 0, Max: 144
Time frame: Baseline, Post 12-Week Treatment, Post Treatment (24 week follow-up)
Population: Number of participants analyzed indicates number of enrolled participants that completed survey questions at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Getting Around | 24.8 score on a scale | Standard Deviation 24.9 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Getting Along | 42.8 score on a scale | Standard Deviation 25.5 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Total Score | 31.6 score on a scale | Standard Deviation 22.7 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Getting Around | 24.9 score on a scale | Standard Deviation 25.1 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Getting Along | 36.9 score on a scale | Standard Deviation 27.8 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Getting Along | 34.4 score on a scale | Standard Deviation 27.3 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Communicating | 31.3 score on a scale | Standard Deviation 22.8 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Work/Activity | 39.8 score on a scale | Standard Deviation 26.2 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Self-Care | 18.1 score on a scale | Standard Deviation 22.7 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Work/Activity | 34.9 score on a scale | Standard Deviation 28.6 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Communicating | 38.4 score on a scale | Standard Deviation 22 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Work/Activity | 34.2 score on a scale | Standard Deviation 26.4 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Self-Care | 14.6 score on a scale | Standard Deviation 21 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Participation | 41.4 score on a scale | Standard Deviation 26.7 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Total Score | 31.0 score on a scale | Standard Deviation 21.6 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Participation | 35.9 score on a scale | Standard Deviation 26.6 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Participation | 38.3 score on a scale | Standard Deviation 27.3 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Self-Care | 13.8 score on a scale | Standard Deviation 17.6 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Communicating | 35.3 score on a scale | Standard Deviation 24.6 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Getting Around | 27.6 score on a scale | Standard Deviation 26.8 |
| STEP-Home | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Total Score | 39.2 score on a scale | Standard Deviation 20.7 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Participation | 36.4 score on a scale | Standard Deviation 21.3 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Total Score | 38.3 score on a scale | Standard Deviation 18.1 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Total Score | 33.5 score on a scale | Standard Deviation 18 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Total Score | 33.7 score on a scale | Standard Deviation 19 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Communicating | 41.1 score on a scale | Standard Deviation 19 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Communicating | 36.5 score on a scale | Standard Deviation 21.6 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Communicating | 36.0 score on a scale | Standard Deviation 20.6 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Getting Around | 24.8 score on a scale | Standard Deviation 24.9 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Getting Around | 26.4 score on a scale | Standard Deviation 23.1 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Getting Around | 27.8 score on a scale | Standard Deviation 25 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Self-Care | 18.4 score on a scale | Standard Deviation 19.9 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Self-Care | 13.9 score on a scale | Standard Deviation 17.7 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Self-Care | 14.7 score on a scale | Standard Deviation 18.9 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Getting Along | 46.7 score on a scale | Standard Deviation 21.7 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Getting Along | 40.4 score on a scale | Standard Deviation 19.9 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Getting Along | 41.0 score on a scale | Standard Deviation 22.6 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Work/Activity | 44.2 score on a scale | Standard Deviation 24.4 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Post-Treatment Work/Activity | 39.7 score on a scale | Standard Deviation 27.8 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Work/Activity | 37.2 score on a scale | Standard Deviation 26.8 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Baseline Participation | 42.4 score on a scale | Standard Deviation 19.8 |
| PCGT | World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) (Change) | Follow-Up Participation | 38.0 score on a scale | Standard Deviation 21 |