Trial of Treatment for Internalized Stigma in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Randomized Controlled Trial of Treatment for Internalized Stigma in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421237
• Other study ID #: R01MH094310-02
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2018
• Source: John Jay College of Criminal Justice, City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Narrative Enhancement and Cognitive Therapy

• Supportive Group Therapy

Locations

Country	Name	City	State
United States	John Jay College, City University of New York	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
John Jay College of Criminal Justice, City University of New York	Indiana University, Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Internalized Stigma of Mental Illness Scale		Up to 11 months post baseline
Primary	Change in Beck Hopelessness Scale		Up to 11 months post baseline
Primary	Change in Rosenberg Self-Esteem Scale		Up to 11 months post baseline
Secondary	Change in Heinrichs Quality of Life Scale		Up to 11 months post baseline