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Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469389
Recruitment Status : Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Serious Mental Illness Behavioral: Engaging in Community Roles and Experiences (ENCoRE) Behavioral: Health & Wellness (H&W) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Negative Symptoms & Community Engagement in Veterans With Schizophrenia
Actual Study Start Date : August 3, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ENCoRE
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.
Behavioral: Engaging in Community Roles and Experiences (ENCoRE)

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 tr

Other Name: ENCoRE

Active Comparator: H&W
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).
Behavioral: Health & Wellness (H&W)

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 (1sessi

Other Name: H&W




Primary Outcome Measures :
  1. Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks ]
    Change in the CAINS affective-motivational deficit subscale score

  2. Schizophrenia Outcomes Functioning Interview (SOFI) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks ]
    Change in SOFI score

  3. Clinical Assessment Interview for Negative Symptoms (CAINS) [ Time Frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks ]
    Change in the CAINS affective-motivational deficit subscale score

  4. Schizophrenia Outcomes Functioning Interview (SOFI) [ Time Frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 24 weeks ]
    Change in SOFI score


Secondary Outcome Measures :
  1. UCSD Performance Based Skills Assessment - Brief Version (UPSA-B) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks ]
    Change in UPSA-B score

  2. Maryland Assessment of Recovery Scale (MARS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks ]
    Change in MARS score

  3. Brief Cognitive Assessment Tool for Schizophrenia (BCATS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks ]
    Relationship of BCATS scores to treatment outcome

  4. Dysfunctional Attitudes Scale (DAS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 12 weeks ]
    Relationship of DAS scores to treatment outcome

  5. UCSD Performance Based Skills Assessment - Brief Version (UPSA-B) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks ]
    Change in UPSA-B score

  6. Maryland Assessment of Recovery Scale (MARS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks ]
    Change in MARS score

  7. Brief Cognitive Assessment Tool for Schizophrenia (BCATS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks ]
    Relationship of BCATS scores to treatment outcome

  8. Dysfunctional Attitudes Scale (DAS) [ Time Frame: Participants will be assessed following completion of the study intervention, an expected average of 24 weeks ]
    Relationship of DAS scores to treatment outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 "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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469389


Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Melanie E Bennett Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02469389    
Obsolete Identifiers: NCT02455349
Other Study ID Numbers: D1293-R
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Schizophrenia
Negative Symptoms
Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders