Pilot RCT of Self-stigma Treatment for First Episode Psychosis

First Episode Psychosis Clinical Trial

— NECT-YA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889911
• Other study ID #: JJayCuny
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: John Jay College of Criminal Justice, City University of New York
• Contact: Bethany Leonhardt, Psy.D.
• Phone: 317-880-8665
• Email: blleonha[@]iupui.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• First Episode Psychosis
• Mental Disorders
• Psychotic Disorders
• Youth

Intervention

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.

Locations

Country	Name	City	State
United States	Eskenazi Health, PARC Program	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
John Jay College of Criminal Justice, City University of New York	Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Internalized Stigma of Mental Illness Scale	A 29 item measure of internalized stigma. Higher scores indicate great internalized stigma.	5 minutes
Other	Positive and Negative Syndrome Scale	The Positive and Negative Syndrome Scale is a 30-item rating scale of psychiatric symptoms associated with psychosis, completed following a chart review and semi-structured interview. Higher scores indicate more symptoms.	20 minutes
Other	Recovery Style Questionnaire Recovery Style Questionnaire	The Recovery Style Questionnaire is a 39 item self-report scale designed to assess the extent to which people with psychosis engage in "sealing over" versus "integration" with regard to how their self-conception.	5 minutes
Primary	Treatment Engagement	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.	0 minutes
Primary	Working Alliance Inventory Short Form-Client Version	A 12-item self-report measure of perception of relationship with the treatment team. Higher scores indicate better working alliance.	2 minutes
Primary	Coping with Symptoms Checklist	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.	15 minutes
Secondary	Beck Hopelessness Scale	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.	3 minutes
Secondary	Rosenberg Self Esteem Scale	The Rosenberg Self Esteem Schedule will be used to measure self-esteem and self-deprecation. Higher scores indicate more self-esteem.	2 minutes
Secondary	Quality of Life Scale	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.	20 minutes