NCT04889911

Pilot RCT of Self-stigma Treatment for First Episode Psychosis

Development of a Stage-specific Adaptation of a Self-stigma Intervention for People Recovering from a First Episode of Psychosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: John Jay College of Criminal Justice, City University of New York · Academic / Other
• Sex: All
• Age: 15 Years – 24 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2021-05-17
• Last updated: 2025-03-24

Locations

1 site across 1 country: United States