Anxiety Disorders
Conditions
Keywords
Cognitive Behavior Therapy
Brief summary
This study is a randomized controlled trial examining the effectiveness of a transdiagnostic cognitive behavioral treatment (CBT) in improving Veterans' community reintegration and quality of life. Veterans with anxiety-based disorders, including posttraumatic stress, panic, social anxiety, and generalized anxiety disorders (with or without co-occurring depression) will be randomized to an intensive CBT (iCBT) treatment delivered over one weekend, standard CBT (sCBT) delivered over 12 weeks or treatment as usual (TAU). The study will also evaluate the potential of the compressed weekend format of iCBT in producing more rapid improvement in outcomes and increasing psychotherapy engagement compared with a standard psychotherapy format. Qualitative interviews will be conducted with Veterans who receive iCBT and their family members to examine how iCBT and environmental factors impacted their process of recovery.
Detailed description
The current project proposes to evaluate a brief but intensive transdiagnostic CBT that simultaneously targets multiple anxiety disorders with or without co-occurring depression. This will be accomplished by evaluating an innovative treatment delivery method that directly addresses barriers associated with standard psychotherapy delivery. The main objectives are to (1) determine if an intensive CBT protocol (iCBT) delivered over one weekend can improve community reintegration, quality of life, and emotional functioning compared with standard CBT (sCBT) and treatment as usual (TAU); (2) examine the rates of psychotherapy engagement in iCBT compared with sCBT; and (3) obtain a deeper understanding, through qualitative interviews with Veterans and their family members, of how iCBT and environmental factors may impact the process of reintegration and quality of life. The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups. Qualitative interviews will be conducted with Veterans who completed iCBT and family members.
Interventions
BEHAVIORALIntensive Cognitive Behavior Therapy (iCBT)
Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
BEHAVIORALStandard Cognitive Behavior Therapy (sCBT)
Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.
Intervention model description
The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans enrolled to receive VA medical care * Current diagnosis of at least one anxiety-based disorder * Moderate-to-poor life enjoyment and satisfaction * Stable on psychotropic medication 4 weeks prior to participation * Willing to be randomized to treatment condition
Exclusion criteria
* Active symptoms of mania or psychosis at baseline * Depression with active suicidal ideation/intent * Moderate-to-severe cognitive impairment * Active drug/alcohol abuse during initial 3 months of study enrollment * Undergoing concurrent transdiagnostic CBT for anxiety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline, 1 Month, 3 Month, 6 Month Follow Ups | The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles. |
| CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline, 1 Month, 3 Month, 6 Month Follow Ups | The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation. |
| CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline, 1 Month, 3 Month, 6 Month Follow Ups | The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation. |
| BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline, 1 Month, 3 Month, 6 Month Follow Ups | The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline, 1 Month, 3 Month, 6 Month Follow Ups | The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning. |
| BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline, 1 Month, 3 Month, 6 Month Follow Ups | The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression. |
Countries
United States
Participant flow
Recruitment details
Veterans at the Michael E. DeBakey VA Medical Center and affiliated community based outpatient clinics were enrolled in this study from 08/1/2018 to 05/31/2021. Veterans were recruited through direct referrals and advertisements.
Pre-assignment details
Enrolled participants were excluded from the study prior to randomization if they did not meet study inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises. | 99 |
| sCBT (Standard Cognitive Behavioral Therapy) Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises. | 98 |
| TAU (Treatment a Usual) Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual. | 67 |
| Total | 264 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 1 Month Follow-Up | Lost to Follow-up | 7 | 4 | 15 |
| 1 Month Follow-Up | Relocated to Different State | 1 | 0 | 1 |
| 1 Month Follow-Up | Withdrawal by Subject | 1 | 0 | 0 |
| 3 Month Follow-Up | Lost to Follow-up | 11 | 11 | 14 |
| 3 Month Follow-Up | Withdrawal by Subject | 1 | 0 | 0 |
| 6 Month Follow-Up | Lost to Follow-up | 12 | 9 | 18 |
| 6 Month Follow-Up | Withdrawal by Subject | 1 | 0 | 0 |
| Treatment | No Longer Interested | 0 | 12 | 0 |
| Treatment | Scheduling Conflicts | 0 | 11 | 0 |
| Treatment | Transportation Issues | 0 | 1 | 0 |
| Treatment | Urgent Family Matters | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | iCBT (Intensive Cognitive Behavioral Therapy) | Total | TAU (Treatment a Usual) | sCBT (Standard Cognitive Behavioral Therapy) |
|---|---|---|---|---|
| Age, Continuous | 42.7 Years STANDARD_DEVIATION 11.2 | 43.4 Years STANDARD_DEVIATION 11.7 | 43.6 Years STANDARD_DEVIATION 11.9 | 43.9 Years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 63 Participants | 14 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 195 Participants | 50 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 129 Participants | 37 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 13 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 7 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 11 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 35 Participants | 95 Participants | 24 Participants | 36 Participants |
| Region of Enrollment United States | 99 Participants | 264 Participants | 67 Participants | 98 Participants |
| Sex: Female, Male Female | 35 Participants | 92 Participants | 23 Participants | 34 Participants |
| Sex: Female, Male Male | 64 Participants | 172 Participants | 44 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 98 | 0 / 67 |
| other Total, other adverse events | 0 / 99 | 0 / 98 | 0 / 67 |
| serious Total, serious adverse events | 0 / 99 | 0 / 98 | 0 / 67 |
Outcome results
Primary
BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Population: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 31.8 score on a scale | Standard Deviation 11.2 |
| iCBT (Intensive Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 24.0 score on a scale | Standard Deviation 12.6 |
| iCBT (Intensive Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 24.3 score on a scale | Standard Deviation 12.2 |
| iCBT (Intensive Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 21.6 score on a scale | Standard Deviation 11.6 |
| sCBT (Standard Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 24.1 score on a scale | Standard Deviation 11.4 |
| sCBT (Standard Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 31.7 score on a scale | Standard Deviation 10.9 |
| sCBT (Standard Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 25.6 score on a scale | Standard Deviation 11.8 |
| sCBT (Standard Cognitive Behavioral Therapy) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 25.9 score on a scale | Standard Deviation 10.3 |
| TAU (Treatment as Usual) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 27.0 score on a scale | Standard Deviation 12.1 |
| TAU (Treatment as Usual) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 26.3 score on a scale | Standard Deviation 12.6 |
| TAU (Treatment as Usual) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 26.7 score on a scale | Standard Deviation 12.4 |
| TAU (Treatment as Usual) | BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 32.0 score on a scale | Standard Deviation 12.1 |
Primary
CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Population: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.21 score on a scale | Standard Deviation 0.7 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.52 score on a scale | Standard Deviation 0.9 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.57 score on a scale | Standard Deviation 0.7 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.70 score on a scale | Standard Deviation 0.7 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.52 score on a scale | Standard Deviation 0.8 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.18 score on a scale | Standard Deviation 0.6 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.54 score on a scale | Standard Deviation 0.9 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.44 score on a scale | Standard Deviation 0.8 |
| TAU (Treatment as Usual) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.36 score on a scale | Standard Deviation 0.8 |
| TAU (Treatment as Usual) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.18 score on a scale | Standard Deviation 0.8 |
| TAU (Treatment as Usual) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.34 score on a scale | Standard Deviation 0.8 |
| TAU (Treatment as Usual) | CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.17 score on a scale | Standard Deviation 0.8 |
Primary
CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Population: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.40 score on a scale | Standard Deviation 0.8 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.52 score on a scale | Standard Deviation 0.9 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.86 score on a scale | Standard Deviation 0.9 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.70 score on a scale | Standard Deviation 0.7 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.52 score on a scale | Standard Deviation 0.8 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.34 score on a scale | Standard Deviation 0.7 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.52 score on a scale | Standard Deviation 0.9 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.44 score on a scale | Standard Deviation 0.8 |
| TAU (Treatment as Usual) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.36 score on a scale | Standard Deviation 0.8 |
| TAU (Treatment as Usual) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.18 score on a scale | Standard Deviation 0.8 |
| TAU (Treatment as Usual) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.40 score on a scale | Standard Deviation 0.9 |
| TAU (Treatment as Usual) | CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.36 score on a scale | Standard Deviation 0.9 |
Primary
CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Population: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.28 score on a scale | Standard Deviation 1 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.80 score on a scale | Standard Deviation 1.1 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.86 score on a scale | Standard Deviation 0.9 |
| iCBT (Intensive Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.96 score on a scale | Standard Deviation 0.8 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.63 score on a scale | Standard Deviation 1 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.26 score on a scale | Standard Deviation 1.2 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.60 score on a scale | Standard Deviation 1 |
| sCBT (Standard Cognitive Behavioral Therapy) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.51 score on a scale | Standard Deviation 1 |
| TAU (Treatment as Usual) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 4.45 score on a scale | Standard Deviation 0.9 |
| TAU (Treatment as Usual) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 4.31 score on a scale | Standard Deviation 1 |
| TAU (Treatment as Usual) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 4.40 score on a scale | Standard Deviation 0.9 |
| TAU (Treatment as Usual) | CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 4.15 score on a scale | Standard Deviation 1 |
Secondary
BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Population: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 31.0 score on a scale | Standard Deviation 10.7 |
| iCBT (Intensive Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 23.5 score on a scale | Standard Deviation 13.4 |
| iCBT (Intensive Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 25.1 score on a scale | Standard Deviation 12.7 |
| iCBT (Intensive Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 22.5 score on a scale | Standard Deviation 12 |
| sCBT (Standard Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 24.4 score on a scale | Standard Deviation 13.5 |
| sCBT (Standard Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 31.0 score on a scale | Standard Deviation 10.6 |
| sCBT (Standard Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 24.8 score on a scale | Standard Deviation 13.2 |
| sCBT (Standard Cognitive Behavioral Therapy) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 24.6 score on a scale | Standard Deviation 11.8 |
| TAU (Treatment as Usual) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 28.8 score on a scale | Standard Deviation 12.8 |
| TAU (Treatment as Usual) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 29.8 score on a scale | Standard Deviation 12.9 |
| TAU (Treatment as Usual) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 28.5 score on a scale | Standard Deviation 13.1 |
| TAU (Treatment as Usual) | BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 32.7 score on a scale | Standard Deviation 11.1 |
Secondary
QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Population: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 34.4 score on a scale | Standard Deviation 7 |
| iCBT (Intensive Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 42.9 score on a scale | Standard Deviation 9.7 |
| iCBT (Intensive Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 42.9 score on a scale | Standard Deviation 10.6 |
| iCBT (Intensive Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 43.7 score on a scale | Standard Deviation 10.1 |
| sCBT (Standard Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 42.5 score on a scale | Standard Deviation 8.8 |
| sCBT (Standard Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 34.8 score on a scale | Standard Deviation 5.5 |
| sCBT (Standard Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 42.0 score on a scale | Standard Deviation 8.9 |
| sCBT (Standard Cognitive Behavioral Therapy) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 40.7 score on a scale | Standard Deviation 8.4 |
| TAU (Treatment as Usual) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 6 Month Follow Up | 38.0 score on a scale | Standard Deviation 8 |
| TAU (Treatment as Usual) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 1 Month Follow Up | 37.4 score on a scale | Standard Deviation 8.3 |
| TAU (Treatment as Usual) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | 3 Month Follow Up | 38.3 score on a scale | Standard Deviation 9.6 |
| TAU (Treatment as Usual) | QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups | Baseline | 33.6 score on a scale | Standard Deviation 7 |