N/A
N=105
Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
Schizophrenia · Serious Mental Illness
Bottom Line
View on ClinicalTrials.gov: NCT02469389 ↗Enrolled (actual)
105
Serious AEs
15.2%
Results posted
Jul 2021
Primary outcome: Primary: Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks — 19.8; 17.3; 17.4; 17.1 score on a scale — p=0.295
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Engaging in Community Roles and Experiences (ENCoRE) (Behavioral); Health & Wellness (H&W) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks |
19.8; 17.3; 17.4; 17.1 | 0.295 |
| PRIMARY Social Functioning Scale (SFS) - 12 Weeks |
110.3; 114.0; 111.1; 112.1 | 0.182 |
| PRIMARY Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks |
19.8; 17.3; 16.2; 17.2 | 0.114 |
| PRIMARY Social Functioning Scale (SFS) - 24 Weeks |
110.3; 114.0; 116.8; 112.7 | 0.220 |
| SECONDARY University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks |
8.5; 8.4; 8.7; 8.1 | 0.018 sig |
| SECONDARY Maryland Assessment of Recovery Scale (MARS) - 12 Weeks |
95.5; 96.7; 95.0; 96.1 | 0.903 |
| SECONDARY Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks |
8.6; 7.1; 6.9; 6.8 | 0.535 |
| SECONDARY Role Functioning Scale (RFS) - 12 Weeks |
9.0; 8.9; 11.0; 9.5 | 0.010 sig |
| SECONDARY University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks |
8.5; 8.4; 8.6; 8.6 | 0.692 |
| SECONDARY Maryland Assessment of Recovery Scale (MARS) - 24 Weeks |
95.5; 96.7; 95.8; 95.5 | 0.498 |
| SECONDARY Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks |
8.6; 7.1; 6.4; 7.6 | 0.079 |
| SECONDARY Role Functioning Scale (RFS) - 24 Weeks |
9.0; 8.9; 10.4; 9.7 | 0.539 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02469389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.