Trial Outcomes & Findings for Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia (NCT NCT02469389)
NCT ID: NCT02469389
Last Updated: 2021-07-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
Results posted on
2021-07-13
Participant Flow
The trial took place at three mid-Atlantic VA Medical Centers; participants were recruited between 12/10/2015 and 7/25/2019.
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.
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
Completed 12-week Assessment
|
40
|
44
|
|
Overall Study
Completed 24-week Assessment
|
37
|
46
|
|
Overall Study
COMPLETED
|
37
|
44
|
|
Overall Study
NOT COMPLETED
|
16
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
Baseline characteristics by cohort
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
57.6 Years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
55.6 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Diagnosis
Schizophrenia
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Diagnosis
Schizoaffective disorder
|
33 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 12 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks
Baseline
|
19.8 score on a scale
Standard Deviation 5.1
|
17.3 score on a scale
Standard Deviation 4.8
|
|
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
|
17.1 score on a scale
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 12 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
Social Functioning Scale (SFS) - 12 Weeks
SFS at baseline assessment
|
110.3 score on a scale
Standard Deviation 20.8
|
114.0 score on a scale
Standard Deviation 19.5
|
|
Social Functioning Scale (SFS) - 12 Weeks
SFS at 12 week assessment
|
111.1 score on a scale
Standard Deviation 19.5
|
112.1 score on a scale
Standard Deviation 112.1
|
PRIMARY outcome
Timeframe: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
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
|
17.3 score on a scale
Standard Deviation 4.8
|
|
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
|
17.2 score on a scale
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
Social Functioning Scale (SFS) - 24 Weeks
SFS at baseline
|
110.3 score on a scale
Standard Deviation 20.8
|
114.0 score on a scale
Standard Deviation 19.5
|
|
Social Functioning Scale (SFS) - 24 Weeks
SFS at 24 week assessment
|
116.8 score on a scale
Standard Deviation 26.5
|
112.7 score on a scale
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 12 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
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
|
8.1 score on a scale
Standard Deviation 1.3
|
|
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 1.0
|
8.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 12 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
Maryland Assessment of Recovery Scale (MARS) - 12 Weeks
MARS score at baseline
|
95.5 score on a scale
Standard Deviation 16.0
|
96.7 score on a scale
Standard Deviation 17.7
|
|
Maryland Assessment of Recovery Scale (MARS) - 12 Weeks
MARS score at 12 week assessment
|
95.0 score on a scale
Standard Deviation 18.2
|
96.1 score on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 12 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
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
|
7.1 score on a scale
Standard Deviation 3.7
|
|
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
|
6.8 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 12 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
Role Functioning Scale (RFS) - 12 Weeks
RFS at 12 week assessment
|
11.0 score on a scale
Standard Deviation 2.7
|
9.5 score on a scale
Standard Deviation 2.6
|
|
Role Functioning Scale (RFS) - 12 Weeks
RFS at baseline
|
9.0 score on a scale
Standard Deviation 2.8
|
8.9 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 24 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
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 1.0
|
8.4 score on a scale
Standard Deviation 1.2
|
|
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
|
8.6 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 24 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
Maryland Assessment of Recovery Scale (MARS) - 24 Weeks
MARS score at baseline
|
95.5 score on a scale
Standard Deviation 16.0
|
96.7 score on a scale
Standard Deviation 17.7
|
|
Maryland Assessment of Recovery Scale (MARS) - 24 Weeks
MARS score at 24 week assessment
|
95.8 score on a scale
Standard Deviation 17.9
|
95.5 score on a scale
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 24 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
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
|
7.1 score on a scale
Standard Deviation 3.7
|
|
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
|
7.6 score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 24 weeksPopulation: All participants randomized to study arm.
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.
Outcome measures
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 Participants
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.
|
Health & Wellness (H&W)
n=52 Participants
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).
|
|---|---|---|
|
Role Functioning Scale (RFS) - 24 Weeks
RFS at baseline
|
9.0 score on a scale
Standard Deviation 2.8
|
8.9 score on a scale
Standard Deviation 3.1
|
|
Role Functioning Scale (RFS) - 24 Weeks
RFS at 24 week assessment
|
10.4 score on a scale
Standard Deviation 2.7
|
9.7 score on a scale
Standard Deviation 2.8
|
Adverse Events
Engaging in Community Roles and Experiences (ENCoRE)
Serious events: 9 serious events
Other events: 4 other events
Deaths: 0 deaths
Health & Wellness (H&W)
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 participants at risk
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.
|
Health & Wellness (H&W)
n=52 participants at risk
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).
|
|---|---|---|
|
General disorders
Hospitalization
|
17.0%
9/53 • Number of events 11 • 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.
|
13.5%
7/52 • Number of events 8 • 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.
|
Other adverse events
| Measure |
Engaging in Community Roles and Experiences (ENCoRE)
n=53 participants at risk
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.
|
Health & Wellness (H&W)
n=52 participants at risk
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).
|
|---|---|---|
|
General disorders
Emergency room visits
|
7.5%
4/53 • Number of events 4 • 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.
|
9.6%
5/52 • Number of events 6 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place