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NCT Number: NCT04889911

Pilot RCT of Self-stigma Treatment for First Episode Psychosis

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.

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Key information

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health, PARC Program

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Bethany Leonhardt, Psy.D.

CONTACT

[email protected]

317-880-8665

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • 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;
  • Speaks English well enough to complete assessments and participate in groups;
  • Is able to provide informed consent to participate.

Exclusion criteria

Does not meet any of the above inclusion criteria.

Treatment and study plan

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

Behavioral

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 names: NECT-YA

Coordinated Specialty Care

Other

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

Other names: CSC

Primary outcomes

  1. Treatment Engagement

    Time frame: 0 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.

  2. Working Alliance Inventory Short Form-Client Version

    Time frame: 2 minutes

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

  3. Coping with Symptoms Checklist

    Time frame: 15 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.

Secondary outcomes

  1. Beck Hopelessness Scale

    Time frame: 3 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.

  2. Rosenberg Self Esteem Scale

    Time frame: 2 minutes

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

  3. Quality of Life Scale

    Time frame: 20 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.

Other outcomes

  1. Internalized Stigma of Mental Illness Scale

    Time frame: 5 minutes

    A 29 item measure of internalized stigma. Higher scores indicate great internalized stigma.

  2. Positive and Negative Syndrome Scale

    Time frame: 20 minutes

    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.

  3. Recovery Style Questionnaire Recovery Style Questionnaire

    Time frame: 5 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bethany Leonhardt, Psy.D.

CONTACT

[email protected]

317-880-8665

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Indiana University

Registry information

Official study title

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

Acronym: NECT-YA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 17, 2021
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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