Trial of Treatment for Internalized Stigma in Schizophrenia

August 6, 2018 updated by: John Jay College of Criminal Justice, City University of New York

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Internalized Stigma of Mental Illness Scale
Time Frame: Up to 11 months post baseline
Up to 11 months post baseline
Change in Beck Hopelessness Scale
Time Frame: Up to 11 months post baseline
Up to 11 months post baseline
Change in Rosenberg Self-Esteem Scale
Time Frame: Up to 11 months post baseline
Up to 11 months post baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Heinrichs Quality of Life Scale
Time Frame: Up to 11 months post baseline
Up to 11 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
John Jay College of Criminal Justice, City University of New York

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Indiana University
Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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