Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469389
• Other study ID #: D1293-R
• Status: Completed
• Phase: N/A
• Start date: August 3, 2015
• Est. completion date: May 27, 2020

Study information

• Verified date: June 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02455349

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Schizophrenia
• Serious Mental Illness

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
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.	Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
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.	Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
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.	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks