Skills Group for Youth at Clinical High-Risk for Psychosis

Testing the Feasibility of a Skills Group for Adolescents and Young Adults at Clinical High-risk for Psychosis

This study is intended to test the feasibility of an integrated cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) skills group for adolescents and young adults at clinical high-risk (CHR) for psychosis. The current study applies a skills group drawing from evidence-based practices (e.g., cognitive behavioral therapy (CBT), dialectical behavioral therapy (DBT)) to those at CHR for psychosis. Up to 30 CHR individuals (starting with a minimum of 3 participants, N accounts for attrition as well), aged 13-18, already receiving clinical services within the HOPE team at University of Pittsburgh will be offered a weekly skills group. Data collected on feasibility and outcome measures will occur pre (within 1 month) -post (up to 4-5 months) and half-way (up to 2-3 months) through the intervention. Taken together, the aim of the proposed intervention is to provide novel insights regarding the utility of a newly developed intervention that integrates both CBT and DBT skills for those at CHR for psychosis.

Study Overview

• Status: Recruiting
• Conditions: Psychological; Clinical High-Risk
• Intervention / Treatment: Behavioral: Skills Group

Detailed Description

The goal of the current study is to integrate cognitive behavioral therapy and dialectical behavioral therapy skills and implement in a group format to a sample of individuals at risk for developing a psychotic disorder. These data have the potential to provide a foundation for intervention development in this area. The group will include weekly sessions for 90 minutes with up to 8 members in the group at a time. Each session will include mindfulness, homework review, and skill development. Each individual in the group will be asked to complete the group for 15-weeks. In the first section of the group, skills will be taught to manage and reduce stress. The second set of skills will include teaching individuals how to improve self-disturbances. The final section of the group will include helping participants improve social skills. Furthermore, parents will be asked to participate in a parent/guardian session 1x a month and will also be asked to also fill out a post-group surveys although this is not mandatory.

It is important to note that all hypotheses are exploratory given the feasibility nature of this study and the sample size. Even so, it is predicted, in an exploratory fashion, that this group will be feasible to implement and there will be improvements in symptoms and functioning.

Changes have been made starting Nov 2024 to the group given the feedback received: (1) Instead of 21-weeks, the group has been modified to to 15-weeks, (2) skills are consistent across stages, implementing only standard DBT skills (instead of radically-open DBT: this applies to stage 3 of the group where the goal is intended to improve social impairments), and (3) the number of outcome measures have been reduced and streamlined to follow the general clinic assessment battery to reduce participant burden.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Bylsma, PHD; Phone Number: 412-624-8363; Email: bylsmalm@upmc.edu
• Study Contact Backup: Name: Tina Gupta, PHD; Phone Number: 412-246-5845; Email: guptat3@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Bellefield Towers
      • Contact: Tina Gupta, MA; Phone Number: 412-246-5845; Email: guptat3@upmc.edu
      • Contact: Leslie Horton, PHD
      • Principal Investigator: Leslie Horton, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Participant Inclusion Criteria:

• 13-18 years of age
• Meet criteria for clinical high-risk syndrome (i.e., at clinical high risk for developing a psychotic disorder). CHR status is determined based off of scoring a 3 (moderate) - 5 (severe) on the Structured Interview for Psychosis-Risk Syndromes and/or having a first degree relative with psychotic disorder and/or the individual meets criteria for schizotypal personality disorder. Additionally individuals with a brief intermittent psychotic symptoms can be included as well (e.g., frankly psychotic symptoms that are very brief)
• Individuals must be enrolled in the HOPE team at the University of Pittsburgh since this group is embedded within that service

Participation Exclusion Criteria:

• Group member meeting criteria for a current/past psychotic disorder

Inclusion Criteria for Parents or Legal Guardians:

• Must be the parent, legal guardian of a 13-18 year-old
• For parents of CHR adolescents, their adolescent must meet criteria for a psychosis-risk syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skills Group; There will be one condition which is the group and participants will complete feasibility and outcome measures at baseline, at midpoint, and at the end of the group.	Behavioral: Skills Group; Adolescents and young adults with a CHR syndrome ages 13-18 will complete feasibility and outcome measures while participating in a weekly skills group for 6 months.; Other Names: Psychosis-risk skills group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attrition	Feasibility measure; this will be assessed by recording the number of individuals that discontinued group participation.	Up to 5 months
Attendance	Feasibility measure; daily attendance will be recorded.	Up to 5 months
Modified Quick Lecomte and Leclerc Scale	Feasibility measure; this modified measure is a a 15-item feasibility measure that assesses feelings about the relevance and importance of group, alliance with the therapists, the group cohesion, appreciation of the group therapy, optimism for the future (five items), feelings about self and others (two items), current mood/anxiety (seven items), distressing thoughts (one item), and feelings about meeting goals (one item). The measure collects data on a 3-point likert scale (0-2), with higher score indicating more group satisfaction/improvement. A mean total score will be collected for each dimension and can range from 0-2. An improvement score taking the proportion of better than usual compared to worse than usual can be calculated for each month of therapy as well.	Up to 5 months
Participation Scale	Feasibility measure; this is a 9-item checklist assessing the participation and behavior of each group member, with each item rated on a 0 (absence of behavior) to 4 (strong presence of behavior) scale. A total score is computed for each person (range 0-36 scale), as well as an average for all group members, with higher scores indicating more group engagement and prosocial behaviors.	Up to 5 months
Change from baseline in the participant group survey at up to 3 months	Feasibility measure; this includes 3 questions about the goals for group and asks general questions about how different areas of the individual's life is going (e.g., feeling present, coping with stress, feeling towards self, 10 questions ranging from 0-40) - individuals are to answer on a 0 (much worse) to 4 (greatly improved) scale with higher scores signaling more improvement. Furthermore, this questionnaire also includes questions about the quality of the group from the participants perspective which will provide qualitative data.	Baseline vs. up to 3 months
Change from up to 3 months in the participant group survey at up to 5 months	Feasibility measure; this includes 3 questions about the goals for group and asks general questions about how different areas of the individual's life is going (e.g., feeling present, coping with stress, feeling towards self, 10 questions ranging from 0-40) - individuals are to answer on a 0 (much worse) to 4 (greatly improved) scale with higher scores signaling more improvement. Furthermore, this questionnaire also includes questions about the quality of the group from the participants perspective which will provide qualitative data.	Up to 3 months vs up to 5 months
Change from baseline in the participant group survey at up to 5 months	Feasibility measure; this includes 3 questions about the goals for group and asks general questions about how different areas of the individual's life is going (e.g., feeling present, coping with stress, feeling towards self, 10 questions ranging from 0-40) - individuals are to answer on a 0 (much worse) to 4 (greatly improved) scale with higher scores signaling more improvement. Furthermore, this questionnaire also includes questions about the quality of the group from the participants perspective which will provide qualitative data.	Baseline vs. up to 5 months
Change from baseline in Satisfaction with Therapy and Therapist Scale at up to 3 months	A satisfaction 13-item scale that asks the individual to indicate their level of satisfaction of the therapy and therapists in the group treatment. Scores fall on a 1 (strong disagree) to 5 (strongly agree) scale with higher numbers indicating higher satisfaction. Scores range from 12-60. There is an additional item that falls on a 1-5 scale that asks about how the tre (atment helped with the specific problem that led to therapy, with higher scores indicating that therapy made things worse (range is 1-5).	Baseline vs. up to 3 months
Change from 3 months in Satisfaction with Therapy and Therapist Scale at up to 5 months	A satisfaction 13-item scale that asks the individual to indicate their level of satisfaction of the therapy and therapists in the group treatment. Scores fall on a 1 (strong disagree) to 5 (strongly agree) scale with higher numbers indicating higher satisfaction. Scores range from 12-60. There is an additional item that falls on a 1-5 scale that asks about how the tre (atment helped with the specific problem that led to therapy, with higher scores indicating that therapy made things worse (range is 1-5).	Up to 3 months vs. up to 5 months.
Fidelity scores	Fidelity scores developed specifically for this group asking questions about the structure of the group meant to be filled out by co-leaders (e.g., was there a mindfulness practice in the session?). Each item can have a Yes or No response. More Yes responses indicate more fidelity. There are a total of 9 items.	Up to 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Trauma Questionnaire	A 28-item screen designed to assess the degree to which different traumatic experiences apply to the individual (e.g., never true (1), rarely (2), sometimes true (3), often true (4), very often true (5)). Higher total scores indicate more traumatic events and scores can range from 28-140. Some items are reverse scored. This questionnaire also measures subscales that have five items each: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. Each subscale ranges from 5-25 with higher scores indicating more trauma exposure.	Baseline
Change from baseline in Lehman Quality of Life Functional Assessment at up to 3 months.	A brief 4- item questionnaire that asks about general feelings about one's life, the amount of fun in life, feeling towards others, and amount of time spent with others on a scale of 0 (terrible) to 6 (delightful) scale. Scores range from 0-24, with lower scores indicating lower quality of life. ~2 minutes	Baseline vs. up to 3 months
Change from up to 3 months in Lehman Quality of Life Functional Assessment at up to 5 months.	A brief 4- item questionnaire that asks about general feelings about one's life, the amount of fun in life, feeling towards others, and amount of time spent with others on a scale of 0 (terrible) to 6 (delightful) scale. Scores range from 0-24, with lower scores indicating lower quality of life. ~2 minutes	Up to 3 months vs. up to 5 months
Change from baseline in Lehman Quality of Life Functional Assessment at up to 5 months.	A brief 4- item questionnaire that asks about general feelings about one's life, the amount of fun in life, feeling towards others, and amount of time spent with others on a scale of 0 (terrible) to 6 (delightful) scale. Scores range from 0-24, with lower scores indicating lower quality of life. ~2 minutes	Baseline vs. up to 5 months
Change from baseline in Perceived Stress Scale at up to 3 months	A 10-item questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Some items are reversed scored. Ratings are collected on a 0 ("never") to 4 ("very often") scale with higher scores indicating more perceived stress, range is 0-40.	Baseline to up to 3 months
Change from up to 3 months in Perceived Stress Scale at up to 5 months.	A 10-item questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Ratings are collected on a 0 ("never") to 4 ("very often") scale with higher scores indicating more perceived stress, range is 0-40.	Up to 3 months vs. up to 5 months
Change from baseline in Perceived Stress Scale at up to 5 months.	A 10-item questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Ratings are collected on a 0 ("never") to 4 ("very often") scale with higher scores indicating more perceived stress, range is 0-40.	Baseline to up to 5 months
Change from baseline in Cognitive Insight Scale at up to 3 months	A 15-item measure evaluating patient's self-reflectiveness and their overconfidence in their interpretations of their experiences. Ratings are collected on a 0 "do not agree at all" to 3 "agree completely" scale ranging from 0-45. A 9-item self-reflectiveness subscale (range 0-27) and a 6-item self-certainty subscale (range 0-18) are also made. Higher scores indicate more insight, self-reflectiveness, and more self-certainty. A composite index of the insight reflecting cognitive insight is calculated by subtracting the score for the self-certainty scale from that of the self-reflectiveness scale where lower numbers indicate less insight.	Baseline vs. up to 3 months
Change from up to 3 months in Cognitive Insight Scale at up to 5 months.	A 15-item measure evaluating patient's self-reflectiveness and their overconfidence in their interpretations of their experiences. Ratings are collected on a 0 "do not agree at all" to 3 "agree completely" scale ranging from 0-45. A 9-item self-reflectiveness subscale (range 0-27) and a 6-item self-certainty subscale (range 0-18) are also made. Higher scores indicate more insight, self-reflectiveness, and more self-certainty. A composite index of the insight reflecting cognitive insight is calculated by subtracting the score for the self-certainty scale from that of the self-reflectiveness scale where lower numbers indicate less insight.	Up to 3 months vs. up to 5 months
Change from baseline in Cognitive Insight Scale at up to 5 months.	A 15-item measure evaluating patient's self-reflectiveness and their overconfidence in their interpretations of their experiences. Ratings are collected on a 0 "do not agree at all" to 3 "agree completely" scale ranging from 0-45. A 9-item self-reflectiveness subscale (range 0-27) and a 6-item self-certainty subscale (range 0-18) are also made. Higher scores indicate more insight, self-reflectiveness, and more self-certainty. A composite index of the insight reflecting cognitive insight is calculated by subtracting the score for the self-certainty scale from that of the self-reflectiveness scale where lower numbers indicate less insight.	Baseline vs. up to 5 months
Change from baseline in Defeatist Performance Attitudes at up to 3 months	A 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. Items are rated on a 1-7 Likert scale and higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.	Baseline vs. Up to 3 months
Change from up to 3 months in Defeatist Performance Attitudes at up to 5 months.	A 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. Items are rated on a 1-7 Likert scale and higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.	Up to 3 months vs up to 5 months
Change from baseline in Defeatist Performance Attitudes at up to 5 months.	A 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. Items are rated on a 1-7 Likert scale and higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.	Baseline vs. up to 5 months
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 3 months	17 items assessing psychological acceptance on a 1 (not at all true) to 5 (very true) scale. Sum scores can range from 17-85 with higher scores representing more psychological inflexibility.	Baseline vs. up to 3 months
Change from up to 3 months in Avoidance Fusion Questionnaire for Youth at up to 5 months	17 items assessing psychological acceptance on a 1 (not at all true) to 5 (very true) scale. Sum scores can range from 17-85 with higher scores representing more psychological inflexibility.	Up to 3 months vs. up to 5 months
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 5 months	17 items assessing psychological acceptance on a 1 (not at all true) to 5 (very true) scale. Sum scores can range from 17-85 with higher scores representing more psychological inflexibility.	Baseline vs. up to 5 months
Change from baseline in Social and Role Functioning Scale at up to 3 months	A brief interview assessing social and role areas of functioning not confounded by symptom ratings and appropriate across life spans; high scores indicate better social functioning. Scores fall on a 1-10 scale.	Baseline vs. up to 3 months
Change from up to 3 months in Social and Role Functioning Scale at up to 5 months	A brief interview assessing social and role areas of functioning not confounded by symptom ratings and appropriate across life spans; high scores indicate better social functioning. Scores fall on a 1-10 scale.	Up to 3 months vs. up to 5 months
Change from baseline in Social and Role Functioning Scale at up to 5 months	A brief interview assessing social and role areas of functioning not confounded by symptom ratings and appropriate across life spans; high scores indicate better social functioning. Scores fall on a 1-10 scale.	Baseline vs. up to 5 months
Change in symptoms from baseline Structured Interview for Psychosis-Risk Syndromes and/or Mini interview (abbreviated version) to up to 3 months	An interview designed to assess five domains of positive symptoms (e.g., seeing shadows). Ratings are given by assessors on a 0 (absent) to 6 (severe) scale. Higher ratings indicate more symptom severity. Scores range from 0-30.	Baseline vs. up to 3 months
Change from up to 3 months on the Structured Interview for Psychosis-Risk Syndromes interview and/or Mini interview (abbreviated version) at up to 5 months	An interview designed to assess five domains of positive symptoms (e.g., seeing shadows). Ratings are given by assessors on a 0 (absent) to 6 (severe) scale. Higher ratings indicate more symptom severity. Scores range from 0-30.	Up to 3 months vs. up to 5 months
Change from baseline in the Structured Interview for Psychosis-Risk Syndromes interview and/or Mini interview (abbreviated version) at up to 5 months	An interview designed to assess five domains of positive symptoms (e.g., seeing shadows). Ratings are given by assessors on a 0 (absent) to 6 (severe) scale. Higher ratings indicate more symptom severity. Scores range from 0-30.	Baseline vs. up to 5 months
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 3 months	A brief, 11-item assessment of negative symptoms, with higher scores indicating more negative symptoms. Two items assess avolition (i.e., reduced motivational behavior and experience), three items assess asociality (i.e., reduction in the desire for and engagement in social activities), two items assess anhedonia (i.e., reduction in pleasure in activities), three items related to affect, and 1 related to quantity of speech. Each of these subscales are summed and/or averaged and there is a total score (range is 0-55) with higher scores indicating more negative symptom severity.	Baseline vs. up to 3 months
Change from up to 3 months in Negative Symptom Inventory Psychosis-Risk at up to 5 months	A brief, 11-item assessment of negative symptoms, with higher scores indicating more negative symptoms. Two items assess avolition (i.e., reduced motivational behavior and experience), three items assess asociality (i.e., reduction in the desire for and engagement in social activities), two items assess anhedonia (i.e., reduction in pleasure in activities), three items related to affect, and 1 related to quantity of speech. Each of these subscales are summed and/or averaged and there is a total score (range is 0-55) with higher scores indicating more negative symptom severity.	Up to 3 months vs. up to 5 months
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 5 months	A brief, 11-item assessment of negative symptoms, with higher scores indicating more negative symptoms. Two items assess avolition (i.e., reduced motivational behavior and experience), three items assess asociality (i.e., reduction in the desire for and engagement in social activities), two items assess anhedonia (i.e., reduction in pleasure in activities), three items related to affect, and 1 related to quantity of speech. Each of these subscales are summed and/or averaged and there is a total score (range is 0-55) with higher scores indicating more negative symptom severity.	Baseline vs. up to 5 months
Change from baseline in Beck Depression Inventory to up to 3 months	A 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a 4 point likert scale with higher scores indicating more depressive symptoms, range 0-63.	Baseline vs. up to 3 months
Change from up to 3 months in Beck Depression Inventory to up to 5 months	A 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a 4 point likert scale with higher scores indicating more depressive symptoms, range 0-63.	Up to 3 months vs. up to 5 months
Change from baseline in Beck Depression Inventory to up to 5 months	A 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a 4 point likert scale with higher scores indicating more depressive symptoms, range 0-63.	Baseline vs. up to 5 months
Change from baseline in Beck Anxiety Inventory at up to 3 months	A 21-item scale measuring common symptoms of anxiety on a 4 point likert scale with higher scores indicating more anxiety, range 0-63.	Baseline vs. up to 3 months
Change from up to 3 months in Beck Anxiety Inventory at up to 5 months	A 21-item scale measuring common symptoms of anxiety on a 4 point likert scale with higher scores indicating more anxiety, range 0-63.	Up to 3 months vs. up to 5 months
Change from baseline in Beck Anxiety Inventory at up to 5 months	A 21-item scale measuring common symptoms of anxiety on a 4 point likert scale with higher scores indicating more anxiety, range 0-63.	Baseline vs. up to 5 months
Change from baseline Child and Adolescent Mindfulness Measure at up to 3 months	A 10 item measure that assesses present-moment awareness and nonjudgmental, nonavoidant responses to thoughts and feelings. Ratings are collected on a 0 (never true) to 4 (always true) and are reverse scored. Scores range from 0-40. Higher scores indicate higher levels of mindfulness.	Baseline vs. up to 3 months
Change from up to 3 months Child and Adolescent Mindfulness Measure at up to 5 months	A 10 item measure that assesses present-moment awareness and nonjudgmental, nonavoidant responses to thoughts and feelings. Ratings are collected on a 0 (never true) to 4 (always true) and are reverse scored. Scores range from 0-40. Higher scores indicate higher levels of mindfulness.	up to 3 months vs. up to 5 months
Change from baseline Child and Adolescent Mindfulness Measure at up to 5 months	A 10 item measure that assesses present-moment awareness and nonjudgmental, nonavoidant responses to thoughts and feelings. Ratings are collected on a 0 (never true) to 4 (always true) and are reverse scored. Scores range from 0-40. Higher scores indicate higher levels of mindfulness.	Baseline vs. up to 5 months
Change from baseline in Emotion Regulation Questionnaire at up to 3 months	A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), and higher scores indicate more use of the noted strategies. Cognitive reappraisal (six items, range 6-42) and expressive suppression items (four items, range 4-28).	Baseline vs. up to 3 months
Change from up to 3 months in Emotion Regulation Questionnaire at up to 5 months	A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), and higher scores indicate more use of the noted strategies. Cognitive reappraisal (six items, range 6-42) and expressive suppression items (four items, range 4-28).	Up to 3 months vs. up to 5 months
Change from baseline in Emotion Regulation Questionnaire at up to 5 months	A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), and higher scores indicate more use of the noted strategies. Cognitive reappraisal (six items, range 6-42) and expressive suppression items (four items, range 4-28).	Baseline vs. up to 5 months
Change from baseline in Social Connectedness Scale at up to 3 months	A 20-item measure to assess how connected one feels to others in their social environment on a 1 (strongly disagree to 6 (strongly agree) scale. All of the items are reversed and are then summed for a total score. A high score reflects more connectedness, range is 20-120.	Baseline vs. up to 3 months
Change from up to 3 months in Social Connectedness Scale at up to 5 months	A 20-item measure to assess how connected one feels to others in their social environment on a 1 (strongly disagree to 6 (strongly agree) scale. All of the items are reversed and are then summed for a total score. A high score reflects more connectedness, range is 20-120.	Up to 3 months vs. up to 5 months
Change from baseline in Social Connectedness Scale at up to 5 months	A 20-item measure to assess how connected one feels to others in their social environment on a 1 (strongly disagree to 6 (strongly agree) scale. All of the items are reversed and are then summed for a total score. A high score reflects more connectedness, range is 20-120.	Baseline vs. up to 5 months
Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 3 months	A 29 item measure that assesses self-stigma on a 1 (strong disagree) - 4 (strongly agree) scale. Scores can range from 29-116 with higher scores indicating more self-stigma. Subscales include alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance.	Baseline vs. up to 3 months
Change in Internalized Stigma Mental Illness Inventory (ISMI) from up to 3 months to up to 5 months	A 29 item measure that assesses self-stigma on a 1 (strong disagree) - 4 (strongly agree) scale. Scores can range from 29-116 with higher scores indicating more self-stigma. Subscales include alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance.	Up to 3 months vs. up to 5 months
Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 5 months	A 29 item measure that assesses self-stigma on a 1 (strong disagree) - 4 (strongly agree) scale. Scores can range from 29-116 with higher scores indicating more self-stigma. Subscales include alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance.	Baseline vs. up to 5 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA)
• Investigators: Principal Investigator: Leslie Horton, PhD, University of Pittsburgh

Publications and helpful links

General Publications

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• Lynch, T. R. (2018b). Radically Open Dialectical Behavior Therapy: Theory and practice for treating disorders of overcontrol. Reno, NV: Context Press, an imprint of New Harbinger Publications, Inc.
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Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Group intervention; Dialectical behavioral therapy skills; Cognitive behavioral therapy skills; Psychosis-risk
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: STUDY21120012; 1 H79 SM081196-01 (Other Grant/Funding Number: Substance Abuse and Mental Health Services Administration (SAMHSA),PA State Dept/Public Welfare)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD underlying publication will be shared including data dictionaries after publication and in line with the grantee policies regarding data sharing. Data will be de-identified before sharing.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Data sharing will be occur when specific requests to analyze data are made by investigators in the field and in line with grant funder data sharing policies
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No