Trial of Treatment for Internalized Stigma in Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Treatment for Internalized Stigma in Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Narrative Enhancement and Cognitive Therapy
* Behavioral: Supportive Group Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental condition<br>Narrative enhancement and cognitive therapy (NECT) groups. Structured psychoeducational and skills-training groups focused on self-stigma and its impact on people with schizophrenia | Behavioral: Narrative Enhancement and Cognitive Therapy<br> <br> |
| Active Comparator: Control condition<br>Supportive group therapy groups. Unstructured supportive groups not focused on self-stigma. | Behavioral: Supportive Group Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Internalized Stigma of Mental Illness Scale |  | Up to 11 months post baseline | 
| Change in Beck Hopelessness Scale |  | Up to 11 months post baseline | 
| Change in Rosenberg Self-Esteem Scale |  | Up to 11 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heinrichs Quality of Life Scale |  | Up to 11 months post baseline |