Pilot RCT of Self-stigma Treatment for First Episode Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorJohn Jay College of Criminal Justice, City University of New York
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care
BehavioralNECT 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.
Coordinated Specialty Care
Other interventionCoordinated Specialty Care is an evidence-based, multimodal intervention for persons who have experienced a first episode of psychosis.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty CareExperimental treatment 2 interventions
Group B: Coordinated Specialty CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
0 minutes2
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.
Time frame
2 minutes3
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.
Time frame
15 minutesSecondary outcomes
1
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.
Time frame
3 minutes2
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.
Time frame
2 minutes3
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.
Time frame
20 minutesOther outcomes
1
Internalized Stigma of Mental Illness Scale
A 29 item measure of internalized stigma. Higher scores indicate great internalized stigma.
Time frame
5 minutes2
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.
Time frame
20 minutes3
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.
Time frame
5 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
John Jay College of Criminal Justice, City University of New York
Lead sponsor
Indiana University
Collaborator
Source ClinicalTrials.gov