Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia

NCT02469389 | Completed Results

• 1 other identifier: D1293-R
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Serious Mental Illness

Keywords

Schizophrenia; Negative Symptoms

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks

  Participants will be assessed following completion of the study intervention, an expected average of 12 weeks

• Maryland Assessment of Recovery Scale (MARS) - 12 Weeks

  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

  Participants will be assessed following completion of the study intervention, an expected average of 12 weeks

• Role Functioning Scale (RFS) - 12 Weeks

  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

  Participants will be assessed following completion of the study intervention, an expected average of 24 weeks

Study Arms (2)

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.

Behavioral: Engaging in Community Roles and Experiences (ENCoRE)

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).

Behavioral: Health & Wellness (H&W)

Interventions

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.

Also known as: ENCoRE

Engaging in Community Roles and Experiences (ENCoRE)

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).

Also known as: H&W

Health & Wellness (H&W)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 36809019 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

enc protein, Drosophila; Health

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Population Characteristics

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Melanie Bennett
• Organization: VISN 5 MIRECC

Melanie.Bennett@va.gov

(410) 637-1850

Study Officials

• Melanie E Bennett

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 11, 2015
• Study Start: August 3, 2015
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)