Pilot RCT of Self-stigma Treatment for First Episode Psychosis

NCT ID: NCT04889911

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-08-31

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.

Detailed 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.

Conditions

First Episode Psychosis; Youth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Coordinated Specialty Care

Intervention Type: OTHER

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

Interventions

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

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.

Intervention Type: BEHAVIORAL

Coordinated Specialty Care

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

Intervention Type: OTHER

Other Intervention Names

NECT-YA; CSC

Eligibility Criteria

Inclusion Criteria

1. 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);

2. 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;

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

4. Is able to provide informed consent to participate.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

John Jay College of Criminal Justice, City University of New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eskenazi Health, PARC Program

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bethany Leonhardt, Psy.D.

Role: CONTACT

blleonha@iupui.edu

317-880-8665

Facility Contacts

Bethany Leonhardt, Psy.D.

Role: primary

Bethany.Leonhardt@eskenazihealth.edu

317-880-8665

Other Identifiers

JJayCuny

Identifier Type: -

Identifier Source: org_study_id