search
Back to results

Pilot RCT of Self-stigma Treatment for First Episode Psychosis (NECT-YA)

Primary Purpose

First Episode Psychosis, Youth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
Coordinated Specialty Care
Sponsored by
John Jay College of Criminal Justice, City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First Episode Psychosis

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eskenazi Health, PARC ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Coordinated Specialty Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 23, 2018
Last Updated
October 4, 2023
Sponsor
John Jay College of Criminal Justice, City University of New York
Collaborators
Indiana University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT04889911
Brief Title
Pilot RCT of Self-stigma Treatment for First Episode Psychosis
Acronym
NECT-YA
Official Title
Development of a Stage-specific Adaptation of a Self-stigma Intervention for People Recovering From a First Episode of Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
John Jay College of Criminal Justice, City University of New York
Collaborators
Indiana University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis, Youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomize controlled trial with random assignment to intervention being studied (NECT-YA) or treatment as usual (Coordinated Specialty Care).
Masking
Outcomes Assessor
Masking Description
Assessors will be kept blind to participant assignment.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Coordinated Specialty Care
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
Other Intervention Name(s)
NECT-YA
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Coordinated Specialty Care
Other Intervention Name(s)
CSC
Intervention Description
Coordinated Specialty Care is an evidence-based, multimodal intervention for persons who have experienced a first episode of psychosis.
Primary Outcome Measure Information:
Title
Treatment Engagement
Description
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.
Time Frame
0 minutes
Title
Working Alliance Inventory Short Form-Client Version
Description
A 12-item self-report measure of perception of relationship with the treatment team. Higher scores indicate better working alliance.
Time Frame
2 minutes
Title
Coping with Symptoms Checklist
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Beck Hopelessness Scale
Description
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.
Time Frame
3 minutes
Title
Rosenberg Self Esteem Scale
Description
The Rosenberg Self Esteem Schedule will be used to measure self-esteem and self-deprecation. Higher scores indicate more self-esteem.
Time Frame
2 minutes
Title
Quality of Life Scale
Description
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.
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
Internalized Stigma of Mental Illness Scale
Description
A 29 item measure of internalized stigma. Higher scores indicate great internalized stigma.
Time Frame
5 minutes
Title
Positive and Negative Syndrome Scale
Description
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.
Time Frame
20 minutes
Title
Recovery Style Questionnaire Recovery Style Questionnaire
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bethany Leonhardt, Psy.D.
Phone
317-880-8665
Email
blleonha@iupui.edu
Facility Information:
Facility Name
Eskenazi Health, PARC Program
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bethany Leonhardt, Psy.D.
Phone
317-880-8665
Email
Bethany.Leonhardt@eskenazihealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilot RCT of Self-stigma Treatment for First Episode Psychosis

We'll reach out to this number within 24 hrs