Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Serious Mental Illness
• Intervention / Treatment: Behavioral: Engaging in Community Roles and Experiences (ENCoRE); Behavioral: Health & Wellness (H&W)

Detailed Description

The goal of this study is to evaluate an innovative psychosocial intervention package that will incorporate evidence-based treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. The intervention - called EnCoRE (Engaging in Community Roles and Experiences) - will include strategies aimed at teaching Veterans with schizophrenia and negative symptoms ways to (1) overcome deficits in anticipatory pleasure, (2) increase intrinsic motivation for goal-directed activities, (3) reduce expectancies for failure, and (4) perform skillfully in new social situations, all of which can impact implementation of new skills and behaviors. Rather than develop a new set of intervention strategies, the investigators will include within EnCoRE evidence-based strategies for these treatment domains. In addition, the investigators will collect qualitative information both from Veterans concerning their perceptions of the strengths, weaknesses, and barriers to participation in EnCoRE, as well as from a sample of mental health providers who work with Veterans with schizophrenia and negative symptoms, in order to inform a larger scale implementation trial should EnCoRE prove effective here.

Following a short pilot to train interventionists and refine the manual, the investigators will conduct a randomized controlled trial to test the efficacy of EnCoRE in improving ratings of negative symptoms, functional outcomes, and engagement in community activities in a sample of Veterans with schizophrenia and negative symptoms (n=108). Participants will be randomized either to EnCoRE or a health-related control group. These goals fit well within the objectives of the Rehabilitation Research and Development (RR&D) program of funding research aimed at studying rehabilitation interventions focused on maximizing functional recovery and assisting in the integration of Veterans into civilian life. Specifically, the investigators will address the following Specific Aims:

Specific Aim 1: Train therapists and refine the EnCoRE manual in a preliminary trial with 10 Veterans with schizophrenia and negative symptoms.

Specific Aim 2: Conduct a randomized controlled trial (n=108, medium effect, alpha=.05) to test the efficacy of EnCoRE in producing positive changes at post-treatment and 3-month follow-up on the primary outcomes of negative symptoms and social and community functioning.

Specific Aim 3: Examine qualitative interviews completed by (1) Veterans who participated in EnCoRE and (2) Mental Health Providers to determine aspects of EnCoRE that were perceived as more or less helpful, interesting, and valuable in order to make adjustments prior to conducting a larger, multi-site implementation trial.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: ENCoRE
Active Comparator: 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).	Behavioral: 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).; Other Names: H&W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Melanie E Bennett, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2015
• Primary Completion (Actual): May 27, 2020
• Study Completion (Actual): May 27, 2020

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Schizophrenia; Negative Symptoms
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Mental Disorders
• Other Study ID Numbers: D1293-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No