Improving Negative Symptoms and Community Engagement in Veterans With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Improving Negative Symptoms and Community Engagement in Veterans With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02455349
• Other study ID #: CIRB# 14-13
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2015
• Last updated: November 2, 2016
• Start date: July 2015
• Est. completion date: May 2019

Study information

• Verified date: November 2016
• Source: VA Maryland Health Care System
• Contact: Kelly Lloyd, M.H.S.
• Phone: 410-637-1887
• Email: Kelly.Lloyd[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenia or schizoaffective disorder

2. A minimum average rating of a "moderate deficit" (2 or greater on a 0 4 scale) on any symptom domain within the affect motivation factor (i.e., symptoms of asociality, avolition, and anhedonia) of the Clinical Assessment Interview for Negative Symptoms (CAINS)

3. Age between 18 and 75 years

4. 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);

5. Competent to sign Informed Consent

Exclusion Criteria:

1. Documented history of serious neurological disorder or head trauma with loss of consciousness

2. 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

3. Inability to effectively participate in the baseline assessments due to psychiatric symptoms on two successive appointments

4. Current problematic substance use as indexed by scores on the Michigan Alcoholism Screening Test and the Drug Abuse Screening Test

5. Currently meet criteria for a major depressive episode

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Engaging in Community Roles &Experiences
This 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, psychoeduation, cognitive therapy, and social skills training.
• Health & Wellness
Education on ways to better manage health-related concerns

Locations

Country	Name	City	State
United States	VA Maryland Health Care System	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Maryland Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Assessment Interview for Negative Symptoms (CAINS)	Change in the CAINS affective-motivational deficit subscale score	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks	No
Primary	Schizophrenia Outcomes Functioning Interview (SOFI)	Change in SOFI score	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks	No
Primary	Clinical Assessment Interview for Negative Symptoms (CAINS)	Change in the CAINS affective-motivational deficit subscale score	Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks.	No
Primary	Schizophrenia Outcomes Functioning Interview (SOFI)	Change in SOFI score	Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks.	No
Secondary	UCSD Performance Based Skills Assessment - Brief Version (UPSA-B)	Change in UPSA-B score	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks	No
Secondary	Maryland Assessment of Recovery Scale (MARS)	Change in MARS score	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks	No
Secondary	Brief Cognitive Assessment Tool for Schizophrenia (BCATS)	Relationship of BCATS scores to treatment outcome	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks	No
Secondary	Dysfunctional Attitudes Scale (DAS)	Relationship of DAS scores to treatment outcome	Participants will be assessed following completion of the study intervention, an expected average of 12 weeks	No
Secondary	UCSD Performance Based Skills Assessment - Brief Version (UPSA-B)	Change in UPSA-B score	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks	No
Secondary	Maryland Assessment of Recovery Scale (MARS)	Change in MARS score	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks	No
Secondary	Brief Cognitive Assessment Tool for Schizophrenia (BCATS)	Relationship of BCATS scores to treatment outcome	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks	No
Secondary	Dysfunctional Attitudes Scale (DAS)	Relationship of DAS scores to treatment outcome	Participants will be assessed following completion of the study intervention, an expected average of 24 weeks	No