Pilot RCT of Self-stigma Treatment for First Episode Psychosis

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
John Jay College of Criminal Justice, City University of New York
Study ID
NCT04889911
Status
Recruiting
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Conditions

  • First Episode Psychosis
  • Youth

Eligibility Criteria

Sex
ALL
Age
15 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care — BEHAVIORAL
    NECT is a psychosocial intervention focused on addressing the effects of self-stigma on individuals diagnosed with severe mental illnesses. For the present study, the intervention has been modified to address the needs of youth who have recently experienced a first episode of psychosis.
  • Coordinated Specialty Care — OTHER
    Coordinated Specialty Care is an evidence-based, multimodal intervention for persons who have experienced a first episode of psychosis.

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Mar 2025
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
    NECT is a structured, 20-session group-based treatment called that combines psychoeducation, cognitive restructuring, and elements of narrative psychotherapy. NECT-YA will be modified to meet the needs of people who have experienced an FEP and may have fewer sessions or be provided in individual format or via telehealth for this study. NECT-YA will be offered to participants who are also receiving treatment within Coordinated Specialty Care programs for First Episode Psychosis.
  • Active Comparator: Coordinated Specialty Care
    Coordinated Specialty Care is an evidence-based treatment for FEP that includes multiple treatment components. The FEP programs in at the recruiting site follow the Coordinated Specialty Care model.

Primary Outcome Measure

Treatment Engagement [ Time Frame: 0 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eskenazi Health, PARC ProgramIndianapolisIndiana46202
Bethany Leonhardt, Psy.D.
[email protected]
317-880-8665

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By research site
Eskenazi Health, PARC Program· Indianapolis, IN

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