CClinicalTrials.gg
CompletedNCT02421237Updated Aug 7, 2018

Trial of Treatment for Internalized Stigma in Schizophrenia

An interventional study of Narrative Enhancement and Cognitive Therapy and Supportive Group Therapy in Schizophrenia, sponsored by John Jay College of Criminal Justice, City University of New York. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by John Jay College of Criminal Justice, City University of New York · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Mar 2013, registered Apr 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia

Browse trials for

03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 170 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

John Jay College of Criminal Justice, City University of New York is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Schizophrenia-spectrum disorder (schizophrenia or schizoaffective)
  • Elevated internalized stigma

Exclusion criteria

Exclusion Criteria:

  • Current substance dependence
  • Inability to speak English
  • Inability to provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
170 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralNarrative Enhancement and Cognitive Therapy
  • BehavioralSupportive Group Therapy
06

What researchers measure

Primary outcomes

  1. Change in Internalized Stigma of Mental Illness Scale

    Time frame: Up to 11 months post baseline

  2. Change in Beck Hopelessness Scale

    Time frame: Up to 11 months post baseline

  3. Change in Rosenberg Self-Esteem Scale

    Time frame: Up to 11 months post baseline

Secondary outcomes

  1. Change in Heinrichs Quality of Life Scale

    Time frame: Up to 11 months post baseline

07

Study locations

1 site
  • John Jay College, City University of New York
    New York, New York 10019, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02421237
Lead sponsor
John Jay College of Criminal Justice, City University of New York
Collaborators
Rutgers University, Indiana University
Responsible party
Sponsor
First posted
Apr 20, 2015
Start date
Mar 2013
Primary completion
Jul 31, 2018
Completion
Jul 31, 2018
Last update
Aug 7, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion