Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
Condition: Schizophrenia; Serious Mental Illness
MeSH terms: Schizophrenia; Mental Disorders
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Engaging in Community Roles and Experiences (ENCoRE); Health & Wellness (H&W)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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).
Other intervention name(s): ENCoRE; H&W
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Negative Symptoms