Pilot RCT of Self-stigma Treatment for First Episode Psychosis (NECT-YA)

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

Status: Enrolling

Conditions: Youth; First Episode Psychosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04889911

JJayCuny

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 24 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

Does not meet any of the above inclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Coordinated Specialty Care

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

Coordinated Specialty Care

Active Comparator group

Description:

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.

Treatment:

Other: Coordinated Specialty Care