Pilot RCT of Self-stigma Treatment for First Episode Psychosis

Last updated: March 19, 2025
Sponsor: John Jay College of Criminal Justice, City University of New York
Overall Status: Active - Recruiting

Phase

N/A

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Treatment

Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care

Coordinated Specialty Care

Clinical Study ID

NCT04889911
JJayCuny
  • Ages 15-24
  • All Genders

Study Summary

The overall purpose of the proposed exploratory intervention development application, is to conduct research that will inform the adaptation and preliminary testing of NECT modified for youth (aged 15-24) with first episode psychosis (FEP), targeting self-concept and illness conceptions to increase treatment engagement. The specific aims of the project are to: 1) adapt NECT to be responsive to the needs and preferences of youth with FEP, and 2) Assess the feasibility, acceptability and preliminary effectiveness of the modified intervention (NECT-YA) combined with coordinated specialty care (CSC) services, compared to CSC services alone, in a small (n = 40) RCT.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meets criteria for FEP youth based on the following definition: age 15-24, onset ofpsychotic symptoms within the last 5 years, and an absence of a primary substanceuse or mood disorder that could be causing the psychotic symptoms (confirmed byprogram eligibility);

  2. Meets criteria for moderate (defined as a mean score of 1-1.5 on the 0-3 scale ofthe Internalized Stigma of Mental lllness Scale [ISMI]) or elevated (defined as amean score of 1.5-3 on the 0-3 scale of the ISMI) self-stigma;

  3. Speaks English well enough to complete assessments and participate in groups;

  4. Is able to provide informed consent to participate.

Exclusion

Exclusion Criteria:

Does not meet any of the above inclusion criteria.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
August 31, 2025

Study Description

The investigators will conduct a small RCT of the modified intervention (NECT-YA), combined with CSC, in comparison with CSC alone, with 40 persons recruited from three FEP programs, assessing acceptability and feasibility, and collecting data on primary outcome (service engagement and therapeutic alliance), related outcomes (self-esteem, hopelessness, and social functioning) and mechanisms of action (self-stigma, illness conceptions and coping). The investigators will also collect qualitative data on participants' impressions of NECT-YA, which will inform additional revisions of the manual.

Connect with a study center

  • Eskenazi Health, PARC Program

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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