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Pilot RCT of Self-stigma Treatment for First Episode Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04889911
Recruitment Status : Not yet recruiting
First Posted : May 17, 2021
Last Update Posted : August 17, 2022
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by (Responsible Party):
John Jay College of Criminal Justice, City University of New York

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE May 17, 2021
Last Update Posted Date August 17, 2022
Estimated Study Start Date  ICMJE December 2022
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2022)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2021)
  • 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
  • Working Alliance Inventory Short Form-Client Version [ Time Frame: 2 minutes ]
    The WAI-SF is a 12-item self-report measure of perception of relationship with the treatment team.
  • Coping with Symptoms Checklist [ Time Frame: 15 minutes ]
    The 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2022)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2021)
  • 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.
  • Rosenberg Self Esteem Scale [ Time Frame: 2 minutes ]
    The Rosenberg Self Esteem Schedule will be used to measure self-esteem and self-deprecation.
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: August 13, 2022)
  • Internalized Stigma of Mental Illness Scale [ Time Frame: 5 minutes ]
    A 29 item measure of internalized stigma. Higher scores indicate great internalized stigma.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: May 13, 2021)
  • Internalized Stigma of Mental Illness Scale [ Time Frame: 5 minutes ]
    The ISMI is a 29-item self-report questionnaire designed to assess subjective experience of stigma. It presents participants with first person statements and asks them to rate them on a 4-point Likert scale. Items are summed to provide four major scale scores: Alienation, Stereotype Endorsement, Discrimination Experience, and Social Withdrawal. The fifth scale, Stigma Resistance, will not be included in total scores given evidence that it does not correlate well with the other subscales.
  • Positive and Negative Syndrome Scale [ Time Frame: 20 minutes ]
    The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale of psychiatric symptoms associated with psychosis, completed following a chart review and semi-structured interview.
  • 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.
 
Descriptive Information
Brief Title  ICMJE Pilot RCT of Self-stigma Treatment for First Episode Psychosis
Official Title  ICMJE Development of a Stage-specific Adaptation of a Self-stigma Intervention for People Recovering From a First Episode of Psychosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomize controlled trial with random assignment to intervention being studied (NECT-YA) or treatment as usual (Coordinated Specialty Care).
Masking: Single (Outcomes Assessor)
Masking Description:
Assessors will be kept blind to participant assignment.
Primary Purpose: Treatment
Condition  ICMJE
  • First Episode Psychosis
  • Youth
Intervention  ICMJE
  • 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 will be modified to address the needs of youth who have recently experienced a first episode of psychosis.
    Other Name: NECT-YA
  • Other: Coordinated Specialty Care
    Coordinated Specialty Care is an evidence-based, multimodal intervention for persons who have experienced a first episode of psychosis.
    Other Name: CSC
Study Arms  ICMJE
  • Experimental: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
    NECT 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.
    Interventions:
    • Behavioral: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
    • Other: Coordinated Specialty Care
  • Active Comparator: Coordinated Specialty Care
    Coordinated 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.
    Intervention: Other: Coordinated Specialty Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2021)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04889911
Other Study ID Numbers  ICMJE JJayCuny
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party John Jay College of Criminal Justice, City University of New York
Original Responsible Party Same as current
Current Study Sponsor  ICMJE John Jay College of Criminal Justice, City University of New York
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Indiana University School of Medicine
Investigators  ICMJE Not Provided
PRS Account John Jay College of Criminal Justice, City University of New York
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP