Baltimore, Maryland 21201


Purpose:

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 summary:

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.


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 "moderate deficit" (3 or greater on a 0-4 scale) on any symptom domain 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 mental health professional at the recruitment site at least once every 3 months for the last 6 months (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 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


NCT ID:

NCT02469389


Primary Contact:

Principal Investigator
Melanie E Bennett
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Melanie E Bennett
Email: Melanie.Bennett@va.gov


Backup Contact:

Email: julia.kindred@va.gov
Julia E Kindred, MS
Phone: (410) 637-1866


Location Contact:

Baltimore, Maryland 21201
United States

Carol Fowler, PhD
Phone: 410-605-7000
Email: carol.fowler@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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