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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Experimental | 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. |
|
| Health & Wellness (H&W) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engaging in Community Roles and Experiences (ENCoRE) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
| 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. | Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks |
| 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. | Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
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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.,:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie E Bennett | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36809019 | Derived | Bennett ME, Kuykendall L, Harvey K, Lucksted A. Increasing community engagement: Skills used by adults with schizophrenia participating in a psychosocial intervention. Psychiatr Rehabil J. 2023 Mar;46(1):83-93. doi: 10.1037/prj0000549. |
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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.
The trial took place at three mid-Atlantic VA Medical Centers; participants were recruited between 12/10/2015 and 7/25/2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
|
5 years
All Serious Adverse Events were medical or psychiatric hospitalizations. All Other Adverse Events were emergency room visits for medical or psychiatric problems that did not result in hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | Hospitalization for a medical or psychiatric disorder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency room visits | General disorders | Systematic Assessment | Emergency room visits for medical or psychiatric disorders |
Target sample size=108 (we randomized 105) to achieve 80% power to detect a Cohen's d type effect size at 12 weeks=0.50 ("medium") on primary outcomes. This may have been too large an effect to expect for a behavioral intervention with an active control; the study may have been underpowered. The arms differed on BL CAINS MAP. We reran all mixed model analyses adjusting for BL CAINS MAP. Results remained the same except the difference in mean change on the CAINS SMAP at FU was significant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melanie Bennett | VISN 5 MIRECC | (410) 637-1850 | Melanie.Bennett@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2019 | May 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2021 | May 23, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C417220 | enc protein, Drosophila |
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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| Health & Wellness (H&W) | Behavioral | 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). |
|
|
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
| 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. | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Diagnosis | Type of schizophrenia spectrum disorder as assessed via a structured diagnostic interview | Count of Participants | Participants |
|
| OG001 | 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). |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 12 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
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| 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. | All participants randomized to study arm. | Posted | Mean | Standard Deviation | score on a scale | Participants will be assessed following completion of the study intervention, an expected average of 24 weeks |
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| 0 |
| 53 |
| 9 |
| 53 |
| 4 |
| 53 |
| EG001 | 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). | 0 | 52 | 7 | 52 | 5 | 52 |
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