Clinical trial NCT02469389: Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
Official title: Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Serious Mental Illness
Keywords: Schizophrenia
Negative Symptoms
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-06-11
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 12 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
measure: Social Functioning Scale (SFS) - 12 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
measure: Clinical Assessment Interview for Negative Symptoms Motivation & Pleasure Scale (CAINS MAP) - 24 Weeks
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
measure: Social Functioning Scale (SFS) - 24 Weeks
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks
Secondary outcomes:
measure: University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 12 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
measure: Maryland Assessment of Recovery Scale (MARS) - 12 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
measure: Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 12 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
measure: Role Functioning Scale (RFS) - 12 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks
measure: University of California San Diego Performance Based Skills Assessment - Brief (UPSA-B) - 24 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
measure: Maryland Assessment of Recovery Scale (MARS) - 24 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
measure: Clinical Assessment Interview for Negative Symptoms Social Motivation and Pleasure Subscale (CAINS SMAP) - 24 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
measure: Role Functioning Scale (RFS) - 24 Weeks
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Melanie E Bennett
role: PRINCIPAL_INVESTIGATOR
References: