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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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04889911
Acronym
NECT-YA
Enrollment
17
Registered
2021-05-17
Start date
2023-08-01
Completion date
2025-10-27
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Episode Psychosis, Youth

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.

Interventions

BEHAVIORALNarrative 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.

OTHERCoordinated Specialty Care

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

Sponsors

John Jay College of Criminal Justice, City University of New York
Lead SponsorOTHER
Indiana University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessors will be kept blind to participant assignment.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment Engagement0 minutesQuantity 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.
Working Alliance Inventory Short Form-Client Version2 minutesA 12-item self-report measure of perception of relationship with the treatment team. Higher scores indicate better working alliance.
Coping with Symptoms Checklist15 minutesAssesses 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.

Secondary

MeasureTime frameDescription
Beck Hopelessness Scale3 minutesThe Beck Hopelessness Scale is a well-established 20-item scale that will be used to measure pessimistic expectations of the future. Individual items are summed to provide an overall index of hope or its absence. Higher scores indicate less hope.
Rosenberg Self Esteem Scale2 minutesThe Rosenberg Self Esteem Schedule will be used to measure self-esteem and self-deprecation. Higher scores indicate more self-esteem.
Quality of Life Scale20 minutesThe Quality of Life Scale is a 21-item scale completed by clinically trained research staff following a semi-structured interview that assesses social functioning in multiple domains. Higher scores indicate great social functioning.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026