Schizophrenia Clinical Trial
Official title:
Improving Negative Symptoms and 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 Engaging in Community Roles & Experiences (ENCoRE) - 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, we 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 Engaging in Community Roles &
Experiences (ENCoRE) - 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, we 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. 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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