Skills Group for Mental Disorders
Phase-Based Progress Estimates
Effectiveness
Safety
Bellefield Towers, Pittsburgh, PA
Mental Disorders+3 More
Skills Group - BehavioralEligibility
< 65
All Sexes
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Eligibility
< 65
All Sexes
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Study Summary
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 16 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 within 1 month of the start of the group, at the midpoint (approximately 3-4 months after baseline), and at the end of the group (approximately 6-7 months after). Some measures will be collected continuously. Furthermore, measures will be collected after each group by the participants and leaders to assess feasibility. Taken together, the aim of the proposed group 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.
Eligible Conditions
- Mental Disorders
- Psychological
- Clinical High-Risk
Treatment Effectiveness
Effectiveness Progress
Other trials for Mental Disorders
Study Objectives
13 Primary · 53 Secondary · Reporting Duration: Up to 4 months vs up to 7 months
Baseline
Child Trauma Questionnaire
Month 4
Change from baseline in Perceived Stress Scale at up to 4 months
Month 7
Change from baseline in Perceived Stress Scale at up to 7 months.
Month 4
Change from baseline in Cognitive Tasks (Hopkins Verbal Learning and Symbol Coding) at up to 4 months
Change from baseline in Defeatist Performance Attitudes at up to 4 months
Change from baseline in group survey for parents at up to 4 months
Month 4
Change from baseline Child and Adolescent Mindfulness Measure at up to 4 months
Change from baseline Overcontrol/uncontrol word pairs at up to 4 months
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 4 months
Change from baseline in Beck Anxiety Inventory at up to 4 months
Change from baseline in Beck Depression Inventory to up to 4 months
Change from baseline in Cognitive Insight Scale at up to 4 months
Change from baseline in Emotion Regulation Questionnaire at up to 4 months
Change from baseline in Lehman Quality of Life Functional Assessment at up to 4 months.
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 4 months
Change from baseline in Prevention through Risk Identification, Management, and Education screen at up to 4 months
Change from baseline in Prodromal Questionnaire, Brief Version at up to 4 months
Change from baseline in Satisfaction with Therapy and Therapist Scale at up to 4 months
Change from baseline in Social Connectedness Scale at up to 4 months
Change from baseline in Social and Role Functioning Scale at up to 4 months
Change from baseline in the participant group survey at up to 4 months
Change in symptoms from baseline Structured Interview for Psychosis-Risk Syndromes to up to 4 months
Month 7
Change from baseline Child and Adolescent Mindfulness Measure at up to 7 months
Change from baseline Overcontrol/uncontrol word pairs at up to 7 months
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 7 months
Change from baseline in Beck Anxiety Inventory at up to 7 months
Change from baseline in Beck Depression Inventory to up to 7 months
Change from baseline in Cognitive Insight Scale at up to 7 months.
Change from baseline in Cognitive Tasks (Verbal Learning and Symbol Coding) at up to 7 months
Change from baseline in Defeatist Performance Attitudes at up to 7 months.
Change from baseline in Emotion Regulation Questionnaire at up to 7 months
Change from baseline in Lehman Quality of Life Functional Assessment at up to 7 months.
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 7 months
Change from baseline in Prevention through Risk Identification, Management, and Education Screen at up to 7 months
Change from baseline in Prodromal Questionnaire, Brief Version at up to 7 months
Change from baseline in Social Connectedness Scale at up to 7 months
Change from baseline in Social and Role Functioning Scale at up to 7 months
Change from baseline in group survey for parents at up to 7 months
Change from baseline in the Structured Interview for Psychosis-Risk Syndromes interview at up to 7 months
Change from baseline in the participant group survey at up to 7 months
Internalized Stigma Mental Illness Inventory (ISMI)
Month 7
Change from up to 4 months in Defeatist Performance Attitudes at up to 7 months.
Change from up to 4 months in the participant group survey at up to 7 months
Month 7
Change from up to 4 months Overcontrol/uncontrol word pairs at up to 7 months
Change from up to 4 months in Avoidance Fusion Questionnaire for Youth at up to 7 months
Change from up to 4 months in Beck Anxiety Inventory at up to 7 months
Change from up to 4 months in Beck Depression Inventory to up to 7 months
Change from up to 4 months in Cognitive Insight Scale at up to 7 months.
Change from up to 4 months in Cognitive Tasks (Verbal Learning and Symbol Coding) at up to 7 months
Change from up to 4 months in Emotion Regulation Questionnaire at up to 7 months
Change from up to 4 months in Lehman Quality of Life Functional Assessment at up to 7 months.
Change from up to 4 months in Negative Symptom Inventory Psychosis-Risk at up to 7 months
Change from up to 4 months in Perceived Stress Scale at up to 7 months.
Change from up to 4 months in Prevention through Risk Identification, Management, and Education Screen at up to 7 months
Change from up to 4 months in Prodromal Questionnaire, Brief Version at up to 7 months
Change from up to 4 months in Social Connectedness Scale at up to 7 months
Change from up to 4 months in Social and Role Functioning Scale at up to 7 months
Change from up to 4 months in group survey for parents at up to 7 months
Change from up to 4 months on the Structured Interview for Psychosis-Risk Syndromes interview at up to 7 months
Month 7
Change from 4 months in Satisfaction with Therapy and Therapist Scale at up to 7 months
Up to 6 months
Attendance
Attrition
Fidelity scores
Modified Quick Lecomte and Leclerc Scale
Participation Scale
Month 7
Change from up to 4 months Child and Adolescent Mindfulness Measure at up to 7 months
Trial Safety
Safety Progress
Other trials for Mental Disorders
Trial Design
1 Treatment Group
Skills Group
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Skills Group · No Placebo Group · N/A
Skills Group
Behavioral
Experimental Group · 1 Intervention: Skills Group · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 months vs up to 7 months
Closest Location: Bellefield Towers · Pittsburgh, PA
2012First Recorded Clinical Trial
1 TrialsResearching Mental Disorders
2 CompletedClinical Trials
Who is running the clinical trial?
Substance Abuse and Mental Health Services Administration (SAMHSA)FED
26 Previous Clinical Trials
24,033 Total Patients Enrolled
7 Trials studying Mental Disorders
1,701 Patients Enrolled for Mental Disorders
University of PittsburghLead Sponsor
1,595 Previous Clinical Trials
6,284,562 Total Patients Enrolled
11 Trials studying Mental Disorders
4,455 Patients Enrolled for Mental Disorders
Leslie Horton, PhDPrincipal InvestigatorUniversity of Pittsburgh
Eligibility Criteria
Age < 65 · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are between the ages of 13 and 18.
You are enrolled in the HOPE team at the University of Pittsburgh.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
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- Leslie Horton 2022. "Skills Group for Those at Clinical High-Risk for Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05398120.
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