Schizophrenia, Serious Mental Illness
Conditions
Keywords
Schizophrenia, Negative Symptoms
Brief summary
The goal of this project is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here.
Detailed description
The goal of this study is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here. Following a short pilot to train interventionists and refine the manual, the investigators will conduct a randomized controlled trial to test the efficacy of EnCoRE in improving ratings of negative symptoms, functional outcomes, and engagement in community activities in a sample of Veterans with schizophrenia and negative symptoms (n=108). Participants will be randomized either to EnCoRE or a health-related control group. These goals fit well within the objectives of the Rehabilitation Research and Development (RR&D) program of funding research aimed at studying rehabilitation interventions focused on maximizing functional recovery and assisting in the integration of Veterans into civilian life. Specifically, the investigators will address the following Specific Aims: Specific Aim 1: Train therapists and refine the EnCoRE manual in a preliminary trial with 10 Veterans with schizophrenia and negative symptoms. Specific Aim 2: Conduct a randomized controlled trial (n=108, medium effect, alpha=.05) to test the efficacy of EnCoRE in producing positive changes at post-treatment and 3-month follow-up on the primary outcomes of negative symptoms and social and community functioning. Specific Aim 3: Examine qualitative interviews completed by (1) Veterans who participated in EnCoRE and (2) Mental Health Providers to determine aspects of EnCoRE that were perceived as more or less helpful, interesting, and valuable in order to make adjustments prior to conducting a larger, multi-site implementation trial.
Interventions
BEHAVIORALEngaging in Community Roles and Experiences (ENCoRE)
Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.
BEHAVIORALHealth & Wellness (H&W)
Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session).
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenia or schizoaffective disorder * A minimum average rating of a moderately severe deficit (3 or greater on a 0-4 scale) on one symptom domain or a minimum average rating of a moderate deficit (2 or greater on a 0-4 scale) on two or more domains, within the affect motivation factor of the Clinical Assessment Interview for Negative Symptoms (CAINS) i.e.,: * symptoms of asociality * avolition * anhedonia * Age between 18 and 75 years * Seen by a service provider twice within the last 6 months or once in the last 6 months consistently for two years, as in line with the Veteran's recorded mental health treatment plan (to demonstrate that participants receive ongoing and regular mental health care) * Competent to sign Informed Consent
Exclusion criteria
* Documented history of serious neurological disorder or head trauma with loss of consciousness * Cognitive impairment (defined as a total intelligence quotient (IQ) score less than 70 as measured by the Wechsler Test of Adult Reading or as indicated by chart review * Inability to effectively participate in the baseline assessments due to psychiatric symptoms on two successive appointments * Current problematic substance use as indexed by scores on the Michigan Alcoholism Screening Test and the Drug Abuse Screening Test * Currently meet criteria for a major depressive episode
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks | Differences in mean change on the CAINS MAP scale from baseline assessment to 12 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome. |
| Social Functioning Scale (SFS) - 12 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks | Differences in mean change on the SFS from baseline assessment to 12 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome. |
| Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks | Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks | Differences in mean change on the CAINS MAP scale from baseline assessment to 24 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome. |
| Social Functioning Scale (SFS) - 24 Weeks | Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks | Differences in mean change on the SFS from baseline assessment to 24 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks | Differences in mean change on the UPSA-B from baseline assessment to 24 week assessment. The UPSA-B has a range of 0-100 with higher scores mean a better outcome. In the present analysis, we used the square root of UPSA-B scores with range 0-10. |
| Maryland Assessment of Recovery Scale (MARS) - 24 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks | Differences in mean change on the MARS from baseline assessment to 24 week assessment. Scores can range from 25-125. Higher scores mean a better outcome. |
| University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks | Differences in mean change on the UPSA-B from baseline assessment to 12 week assessment. The UPSA-B has a range of 0-100 with higher scores mean a better outcome. In the present analysis, we used the square root of UPSA-B scores with range 0-10. |
| Role Functioning Scale (RFS) - 24 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks | Differences in mean change on the RFS from baseline assessment to 24 week assessment. Items are rated on a 1 to 7 scale. In the present analysis, we summed ratings of Family Network Relationships and Immediate Social Network Relationships as our measure of role functioning. Scores can range from 2-14. Higher scores mean a better outcome. |
| Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks | Differences in mean change on the CAINS SMAP from baseline assessment to 24 week assessment. This subscale has a total of 4 items each rated on a 0-4 score. The range of scores was 0-16. Lower scores mean a better outcome. |
| Maryland Assessment of Recovery Scale (MARS) - 12 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks | Differences in mean change on the MARS from baseline assessment to 12 week assessment. Scores can range from 25-125. Higher scores mean a better outcome. |
| Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks | Differences in mean change on the CAINS SMAP from baseline assessment to 12 week assessment. This subscale has a total of 4 items each rated on a 0-4 score. The range of scores was 0-16. Lower scores mean a better outcome. |
| Role Functioning Scale (RFS) - 12 Weeks | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks | Differences in mean change on the RFS from baseline assessment to 12 week assessment. Items are rated on a 1 to 7 scale. In the present analysis, we summed ratings of Family Network Relationships and Immediate Social Network Relationships as our measure of role functioning. Scores can range from 2-14. Higher scores mean a better outcome. |
Countries
United States
Participant flow
Recruitment details
The trial took place at three mid-Atlantic VA Medical Centers; participants were recruited between 12/10/2015 and 7/25/2019.
Pre-assignment details
154 individuals signed consent to participate. Of these, 49 were not randomized due to: (1) 41 did not pass eligibility screening; (2) 7 did not complete screening; (3) 1 did not complete the baseline assessment.
Participants by arm
| Arm | Count |
|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.
Engaging in Community Roles and Experiences (ENCoRE): Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training. | 53 |
| Health & Wellness (H&W) Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application. Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session).
Health & Wellness (H&W): Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application.
Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session). | 52 |
| Total | 105 |
Baseline characteristics
| Characteristic | Health & Wellness (H&W) | Engaging in Community Roles and Experiences (ENCoRE) | Total |
|---|---|---|---|
| Age, Continuous | 57.6 Years STANDARD_DEVIATION 9.1 | 53.6 Years STANDARD_DEVIATION 11.7 | 55.6 Years STANDARD_DEVIATION 10.6 |
| Diagnosis Schizoaffective disorder | 22 Participants | 33 Participants | 55 Participants |
| Diagnosis Schizophrenia | 30 Participants | 20 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 53 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 42 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 49 Participants | 47 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 4 / 53 | 5 / 52 |
| serious Total, serious adverse events | 9 / 53 | 7 / 52 |
Outcome results
Primary
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks
Differences in mean change on the CAINS MAP scale from baseline assessment to 12 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks | Baseline | 19.8 score on a scale | Standard Deviation 5.1 |
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks | 12 week assessment | 17.4 score on a scale | Standard Deviation 5.8 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks | Baseline | 17.3 score on a scale | Standard Deviation 4.8 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks | 12 week assessment | 17.1 score on a scale | Standard Deviation 4.9 |
Comparison: Analyses of the primary and secondary outcomes utilized a linear mixed effects model accounting for random therapy group effects and included all available data at baseline (BL), post-treatment (PT; 12-week), and follow-up (FU; 24-week) timepoints (TPs). Error terms across TPs were assumed correlated with unstructured correlation matrix. To test time specific hypotheses, terms in the mean model included separate indicators for PT \& FU \& interaction terms between these indicators and conditions.p-value: 0.295Mixed Models Analysis
Primary
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks
Differences in mean change on the CAINS MAP scale from baseline assessment to 24 week assessment. This scale contains a total of 9 items, each with a range of 0-4. Scores range from 0-36. Lower scores mean a better outcome.
Time frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks | CAINS MAP at baseline assessment | 19.8 score on a scale | Standard Deviation 5.1 |
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks | CAINS MAP at 24 week assessment | 16.2 score on a scale | Standard Deviation 6.1 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks | CAINS MAP at baseline assessment | 17.3 score on a scale | Standard Deviation 4.8 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks | CAINS MAP at 24 week assessment | 17.2 score on a scale | Standard Deviation 5.3 |
p-value: 0.114Mixed Models Analysis
Primary
Social Functioning Scale (SFS) - 12 Weeks
Differences in mean change on the SFS from baseline assessment to 12 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Social Functioning Scale (SFS) - 12 Weeks | SFS at baseline assessment | 110.3 score on a scale | Standard Deviation 20.8 |
| Engaging in Community Roles and Experiences (ENCoRE) | Social Functioning Scale (SFS) - 12 Weeks | SFS at 12 week assessment | 111.1 score on a scale | Standard Deviation 19.5 |
| Health & Wellness (H&W) | Social Functioning Scale (SFS) - 12 Weeks | SFS at 12 week assessment | 112.1 score on a scale | Standard Deviation 112.1 |
| Health & Wellness (H&W) | Social Functioning Scale (SFS) - 12 Weeks | SFS at baseline assessment | 114.0 score on a scale | Standard Deviation 19.5 |
p-value: 0.182Mixed Models Analysis
Primary
Social Functioning Scale (SFS) - 24 Weeks
Differences in mean change on the SFS from baseline assessment to 24 week assessment. In the present analysis, we used a total score for the SFS including all subscales except the employment subscale. Scores ranged from 13-213. Higher scores mean a better outcome.
Time frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Social Functioning Scale (SFS) - 24 Weeks | SFS at baseline | 110.3 score on a scale | Standard Deviation 20.8 |
| Engaging in Community Roles and Experiences (ENCoRE) | Social Functioning Scale (SFS) - 24 Weeks | SFS at 24 week assessment | 116.8 score on a scale | Standard Deviation 26.5 |
| Health & Wellness (H&W) | Social Functioning Scale (SFS) - 24 Weeks | SFS at baseline | 114.0 score on a scale | Standard Deviation 19.5 |
| Health & Wellness (H&W) | Social Functioning Scale (SFS) - 24 Weeks | SFS at 24 week assessment | 112.7 score on a scale | Standard Deviation 20.4 |
p-value: 0.22Mixed Models Analysis
Secondary
Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks
Differences in mean change on the CAINS SMAP from baseline assessment to 12 week assessment. This subscale has a total of 4 items each rated on a 0-4 score. The range of scores was 0-16. Lower scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks | SMAP rating at baseline | 8.6 score on a scale | Standard Deviation 3.4 |
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks | SMAP rating at 12 week assessment | 6.9 score on a scale | Standard Deviation 3.7 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks | SMAP rating at baseline | 7.1 score on a scale | Standard Deviation 3.7 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks | SMAP rating at 12 week assessment | 6.8 score on a scale | Standard Deviation 3.4 |
p-value: 0.535Mixed Models Analysis
Secondary
Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks
Differences in mean change on the CAINS SMAP from baseline assessment to 24 week assessment. This subscale has a total of 4 items each rated on a 0-4 score. The range of scores was 0-16. Lower scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks | CAINS SMAP score at 24 week assessment | 6.4 score on a scale | Standard Deviation 3.7 |
| Engaging in Community Roles and Experiences (ENCoRE) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks | CAINS SMAP score at baseline | 8.6 score on a scale | Standard Deviation 3.4 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks | CAINS SMAP score at 24 week assessment | 7.6 score on a scale | Standard Deviation 3.6 |
| Health & Wellness (H&W) | Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks | CAINS SMAP score at baseline | 7.1 score on a scale | Standard Deviation 3.7 |
p-value: 0.079Mixed Models Analysis
Secondary
Maryland Assessment of Recovery Scale (MARS) - 12 Weeks
Differences in mean change on the MARS from baseline assessment to 12 week assessment. Scores can range from 25-125. Higher scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Maryland Assessment of Recovery Scale (MARS) - 12 Weeks | MARS score at baseline | 95.5 score on a scale | Standard Deviation 16 |
| Engaging in Community Roles and Experiences (ENCoRE) | Maryland Assessment of Recovery Scale (MARS) - 12 Weeks | MARS score at 12 week assessment | 95.0 score on a scale | Standard Deviation 18.2 |
| Health & Wellness (H&W) | Maryland Assessment of Recovery Scale (MARS) - 12 Weeks | MARS score at baseline | 96.7 score on a scale | Standard Deviation 17.7 |
| Health & Wellness (H&W) | Maryland Assessment of Recovery Scale (MARS) - 12 Weeks | MARS score at 12 week assessment | 96.1 score on a scale | Standard Deviation 19.4 |
p-value: 0.903Mixed Models Analysis
Secondary
Maryland Assessment of Recovery Scale (MARS) - 24 Weeks
Differences in mean change on the MARS from baseline assessment to 24 week assessment. Scores can range from 25-125. Higher scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Maryland Assessment of Recovery Scale (MARS) - 24 Weeks | MARS score at baseline | 95.5 score on a scale | Standard Deviation 16 |
| Engaging in Community Roles and Experiences (ENCoRE) | Maryland Assessment of Recovery Scale (MARS) - 24 Weeks | MARS score at 24 week assessment | 95.8 score on a scale | Standard Deviation 17.9 |
| Health & Wellness (H&W) | Maryland Assessment of Recovery Scale (MARS) - 24 Weeks | MARS score at baseline | 96.7 score on a scale | Standard Deviation 17.7 |
| Health & Wellness (H&W) | Maryland Assessment of Recovery Scale (MARS) - 24 Weeks | MARS score at 24 week assessment | 95.5 score on a scale | Standard Deviation 19.2 |
p-value: 0.498Mixed Models Analysis
Secondary
Role Functioning Scale (RFS) - 12 Weeks
Differences in mean change on the RFS from baseline assessment to 12 week assessment. Items are rated on a 1 to 7 scale. In the present analysis, we summed ratings of Family Network Relationships and Immediate Social Network Relationships as our measure of role functioning. Scores can range from 2-14. Higher scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Role Functioning Scale (RFS) - 12 Weeks | RFS at baseline | 9.0 score on a scale | Standard Deviation 2.8 |
| Engaging in Community Roles and Experiences (ENCoRE) | Role Functioning Scale (RFS) - 12 Weeks | RFS at 12 week assessment | 11.0 score on a scale | Standard Deviation 2.7 |
| Health & Wellness (H&W) | Role Functioning Scale (RFS) - 12 Weeks | RFS at baseline | 8.9 score on a scale | Standard Deviation 3.1 |
| Health & Wellness (H&W) | Role Functioning Scale (RFS) - 12 Weeks | RFS at 12 week assessment | 9.5 score on a scale | Standard Deviation 2.6 |
p-value: 0.01Mixed Models Analysis
Secondary
Role Functioning Scale (RFS) - 24 Weeks
Differences in mean change on the RFS from baseline assessment to 24 week assessment. Items are rated on a 1 to 7 scale. In the present analysis, we summed ratings of Family Network Relationships and Immediate Social Network Relationships as our measure of role functioning. Scores can range from 2-14. Higher scores mean a better outcome.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Role Functioning Scale (RFS) - 24 Weeks | RFS at baseline | 9.0 score on a scale | Standard Deviation 2.8 |
| Engaging in Community Roles and Experiences (ENCoRE) | Role Functioning Scale (RFS) - 24 Weeks | RFS at 24 week assessment | 10.4 score on a scale | Standard Deviation 2.7 |
| Health & Wellness (H&W) | Role Functioning Scale (RFS) - 24 Weeks | RFS at baseline | 8.9 score on a scale | Standard Deviation 3.1 |
| Health & Wellness (H&W) | Role Functioning Scale (RFS) - 24 Weeks | RFS at 24 week assessment | 9.7 score on a scale | Standard Deviation 2.8 |
p-value: 0.539Mixed Models Analysis
Secondary
University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks
Differences in mean change on the UPSA-B from baseline assessment to 12 week assessment. The UPSA-B has a range of 0-100 with higher scores mean a better outcome. In the present analysis, we used the square root of UPSA-B scores with range 0-10.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks | UPSA-B at baseline | 8.5 score on a scale | Standard Deviation 1 |
| Engaging in Community Roles and Experiences (ENCoRE) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks | UPSA-B at 12 week assessment | 8.7 score on a scale | Standard Deviation 0.8 |
| Health & Wellness (H&W) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks | UPSA-B at 12 week assessment | 8.1 score on a scale | Standard Deviation 1.3 |
| Health & Wellness (H&W) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks | UPSA-B at baseline | 8.4 score on a scale | Standard Deviation 1.2 |
p-value: 0.018Mixed Models Analysis
Secondary
University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks
Differences in mean change on the UPSA-B from baseline assessment to 24 week assessment. The UPSA-B has a range of 0-100 with higher scores mean a better outcome. In the present analysis, we used the square root of UPSA-B scores with range 0-10.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Population: All participants randomized to study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks | UPSA-B score at baseline | 8.5 score on a scale | Standard Deviation 1 |
| Engaging in Community Roles and Experiences (ENCoRE) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks | UPSA-B score at 24 week assessment | 8.6 score on a scale | Standard Deviation 0.8 |
| Health & Wellness (H&W) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks | UPSA-B score at baseline | 8.4 score on a scale | Standard Deviation 1.2 |
| Health & Wellness (H&W) | University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks | UPSA-B score at 24 week assessment | 8.6 score on a scale | Standard Deviation 0.9 |
p-value: 0.692Mixed Models Analysis