Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia



Status:Recruiting
Conditions:Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:2/2/2019
Start Date:August 3, 2015
End Date:July 31, 2020
Contact:Melanie E Bennett
Email:Melanie.Bennett@va.gov

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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.

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.

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
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Melanie E Bennett
Phone: 410-605-7000
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mi
from
Baltimore, MD
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