Trial of Treatment for Internalized Stigma in Schizophrenia

Randomized Controlled Trial of Treatment for Internalized Stigma in Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Narrative Enhancement and Cognitive Therapy; Behavioral: Supportive Group Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • John Jay College, City University of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental condition; 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
Active Comparator: Control condition; Supportive group therapy groups. Unstructured supportive groups not focused on self-stigma.	Behavioral: Supportive Group Therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: John Jay College of Criminal Justice, City University of New York
• Collaborators: Indiana University; Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: R01MH094310-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No