Clinical trial NCT04889911: Pilot RCT of Self-stigma Treatment for First Episode Psychosis
Official title: Development of a Stage-specific Adaptation of a Self-stigma Intervention for People Recovering from a First Episode of Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: First Episode Psychosis
Youth
Lead sponsor: John Jay College of Criminal Justice, City University of New York
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
First posted: 2021-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomize controlled trial with random assignment to intervention being studied (NECT-YA) or treatment as usual (Coordinated Specialty Care).
Primary purpose: TREATMENT

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.

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.

Exclusion Criteria:

Does not meet any of the above inclusion criteria.

Primary outcomes:
measure: Treatment Engagement
timeFrame: 0 minutes
measure: Working Alliance Inventory Short Form-Client Version
timeFrame: 2 minutes
measure: Coping with Symptoms Checklist
timeFrame: 15 minutes
Secondary outcomes:
measure: Beck Hopelessness Scale
timeFrame: 3 minutes
measure: Rosenberg Self Esteem Scale
timeFrame: 2 minutes
measure: Quality of Life Scale
timeFrame: 20 minutes
Other outcomes:
measure: Internalized Stigma of Mental Illness Scale
timeFrame: 5 minutes
measure: Positive and Negative Syndrome Scale
timeFrame: 20 minutes
measure: Recovery Style Questionnaire Recovery Style Questionnaire
timeFrame: 5 minutes
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health, PARC Program
state: Indiana
Study officials:
References: