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Pilot RCT of Self-stigma Treatment for First Episode Psychosis

Not Applicable
Recruiting
Conditions
Youth
First Episode Psychosis
Interventions
Other: Coordinated Specialty Care
Behavioral: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
Registration Number
NCT04889911
Lead Sponsor
John Jay College of Criminal Justice, City University of New York
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Coordinated Specialty CareCoordinated Specialty CareCoordinated 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.
Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty CareNarrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty CareNECT 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.
Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty CareCoordinated Specialty CareNECT 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.
Primary Outcome Measures
NameTimeMethod
Coping with Symptoms Checklist15 minutes

Assesses 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.

Working Alliance Inventory Short Form-Client Version2 minutes

A 12-item self-report measure of perception of relationship with the treatment team. Higher scores indicate better working alliance.

Treatment Engagement0 minutes

Quantity 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.

Secondary Outcome Measures
NameTimeMethod
Rosenberg Self Esteem Scale2 minutes

The Rosenberg Self Esteem Schedule will be used to measure self-esteem and self-deprecation. Higher scores indicate more self-esteem.

Quality of Life Scale20 minutes

The 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.

Beck Hopelessness Scale3 minutes

The 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.

Trial Locations

Locations (1)

Eskenazi Health, PARC Program

🇺🇸

Indianapolis, Indiana, United States

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