Trial of Treatment for Internalized Stigma in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative Enhancement and Cognitive Therapy
Supportive Group Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Schizophrenia-spectrum disorder (schizophrenia or schizoaffective)
- Elevated internalized stigma
Exclusion Criteria:
- Current substance dependence
- Inability to speak English
- Inability to provide informed consent
Sites / Locations
- John Jay College, City University of New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental condition
Control condition
Arm Description
Narrative enhancement and cognitive therapy (NECT) groups. Structured psychoeducational and skills-training groups focused on self-stigma and its impact on people with schizophrenia
Supportive group therapy groups. Unstructured supportive groups not focused on self-stigma.
Outcomes
Primary Outcome Measures
Change in Internalized Stigma of Mental Illness Scale
Change in Beck Hopelessness Scale
Change in Rosenberg Self-Esteem Scale
Secondary Outcome Measures
Change in Heinrichs Quality of Life Scale
Full Information
NCT ID
NCT02421237
First Posted
April 10, 2015
Last Updated
August 6, 2018
Sponsor
John Jay College of Criminal Justice, City University of New York
Collaborators
Rutgers University, Indiana University
1. Study Identification
Unique Protocol Identification Number
NCT02421237
Brief Title
Trial of Treatment for Internalized Stigma in Schizophrenia
Official Title
Randomized Controlled Trial of Treatment for Internalized Stigma in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
John Jay College of Criminal Justice, City University of New York
Collaborators
Rutgers University, Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the present study is to build upon the investigators' previous exploratory intervention development study by conducting an adequately-powered, randomized controlled trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with schizophrenia-spectrum disorders.
Detailed Description
Internalized (or self) stigma develops when people with mental illness become aware of stigmatizing attitudes held by many in society about mental illness (e.g., dangerousness, incompetence, inability to work), perceive these attitudes as being legitimate, and apply them to themselves. There is substantial evidence that internalized stigma is strongly negatively linked to both the objective (e.g., social functioning) and subjective (e.g., self-esteem and well-being) components of recovery for persons with schizophrenia, and that these effects operate independent of symptom-related disability. Nevertheless, few efforts have been made to develop treatment to address this issue. Previously, the investigators were funded to develop a group-based intervention (R34MH082161) combining cognitive-behavioral therapy and narrative psychotherapy to address internalized stigma among people with severe mental illness. The purpose of the present study is to build upon the investigators' previous exploratory intervention development study by conducting an adequately-powered, randomized controlled trial of the Narrative Enhancement/Cognitive Therapy (NECT) intervention among persons with schizophrenia-spectrum disorders. The investigators will screen 500 persons at two sites (Newark, New Jersey and Indianapolis, IN) for evidence of moderate or elevated internalized stigma. They will conduct a randomized study of NECT versus supportive group therapy in a sample of 175 individuals meeting Structured Clinical Interview criteria for schizophrenia-spectrum disorders. Randomization will be stratified by baseline self-stigma severity (moderate or elevated), to ensure roughly equal numbers of participants for each stratum. Participants will complete baseline, post-treatment, 3-month post treatment and 6-month post treatment assessments of internalized stigma, psychiatric symptoms, insight, self-esteem, hopelessness, coping, narrative coherence and social functioning. The specific aims of the project are: 1) Conduct a randomized study of the effectiveness of NECT, comparing outcomes for 175 persons with schizophrenia-spectrum disorder randomly assigned to NECT or supportive group therapy, 2) Examine the mediating impact of changes in narrative coherence and in the use of problem-centered coping strategies on outcomes for persons assigned to the NECT treatment. The intervention can have important implications for enhancing usual care services to reduce disability for people with schizophrenia, and therefore has potentially important implications for improving the public health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental condition
Arm Type
Experimental
Arm Description
Narrative enhancement and cognitive therapy (NECT) groups. Structured psychoeducational and skills-training groups focused on self-stigma and its impact on people with schizophrenia
Arm Title
Control condition
Arm Type
Active Comparator
Arm Description
Supportive group therapy groups. Unstructured supportive groups not focused on self-stigma.
Intervention Type
Behavioral
Intervention Name(s)
Narrative Enhancement and Cognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Supportive Group Therapy
Primary Outcome Measure Information:
Title
Change in Internalized Stigma of Mental Illness Scale
Time Frame
Up to 11 months post baseline
Title
Change in Beck Hopelessness Scale
Time Frame
Up to 11 months post baseline
Title
Change in Rosenberg Self-Esteem Scale
Time Frame
Up to 11 months post baseline
Secondary Outcome Measure Information:
Title
Change in Heinrichs Quality of Life Scale
Time Frame
Up to 11 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Schizophrenia-spectrum disorder (schizophrenia or schizoaffective)
Elevated internalized stigma
Exclusion Criteria:
Current substance dependence
Inability to speak English
Inability to provide informed consent
Facility Information:
Facility Name
John Jay College, City University of New York
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Trial of Treatment for Internalized Stigma in Schizophrenia
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