Pilot RCT of Self-stigma Treatment for First Episode Psychosis

NCT04889911 | Recruiting DMC

• 1 other identifier: JJayCuny
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

First Episode Psychosis; Youth

Outcome Measures

Primary Outcomes (3)

• Treatment Engagement

  Quantity of service use will be measured using attendance records for groups collected by facilitators, as well as administrative data on total service use within the FEP programs.

  0 minutes

• Working Alliance Inventory Short Form-Client Version

  A 12-item self-report measure of perception of relationship with the treatment team. Higher scores indicate better working alliance.

  2 minutes

• Coping with Symptoms Checklist

  Assesses the use of problem-centered, neutral and avoidant coping strategies to deal with a variety of psychiatric symptoms commonly experienced by people with severe mental illnesses. Higher scores in each subscale indicate more use of that type of coping strategy.

  15 minutes

Secondary Outcomes (3)

• Beck Hopelessness Scale

  3 minutes

• Rosenberg Self Esteem Scale

  2 minutes

• Quality of Life Scale

  20 minutes

Other Outcomes (3)

• Internalized Stigma of Mental Illness Scale

  5 minutes

• Positive and Negative Syndrome Scale

  20 minutes

• Recovery Style Questionnaire Recovery Style Questionnaire

  5 minutes

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care; Other: Coordinated Specialty Care

Coordinated Specialty Care

ACTIVE COMPARATOR

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.

Other: Coordinated Specialty Care

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.

Also known as: NECT-YA

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

Coordinated Specialty Care OTHER

Coordinated Specialty Care is an evidence-based, multimodal intervention for persons who have experienced a first episode of psychosis.

Also known as: CSC

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

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meets criteria for FEP youth based on the following definition: age 15-24, onset of psychotic symptoms within the last 5 years, and an absence of a primary substance use or mood disorder that could be causing the psychotic symptoms (confirmed by program eligibility);
• Meets criteria for moderate (defined as a mean score of 1-1.5 on the 0-3 scale of the Internalized Stigma of Mental lllness Scale \[ISMI\]) or elevated (defined as a mean score of 1.5-3 on the 0-3 scale of the ISMI) self-stigma;
• Speaks English well enough to complete assessments and participate in groups;
• Is able to provide informed consent to participate.

Sponsors & Collaborators

• John Jay College of Criminal Justice, City University of New York: lead
• Indiana University School of Medicine: collaborator

Study Sites (1)

Eskenazi Health, PARC Program

Indianapolis, Indiana, 46202, United States

RECRUITING

Central Study Contacts

Bethany Leonhardt, Psy.D.

CONTACT

317-880-8665; blleonha@iupui.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be kept blind to participant assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomize controlled trial with random assignment to intervention being studied (NECT-YA) or treatment as usual (Coordinated Specialty Care).

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: May 17, 2021
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)