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Combined CBT and DBT Skills Group for High-Risk Psychosis

N/A
Recruiting
Led By Leslie Horton, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
13-18 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months vs up to 7 months
Awards & highlights

Study Summary

This trial is testing a new therapy that combines two existing therapies, CBT and DBT, to see if it helps adolescents and young adults at risk for psychosis.

Who is the study for?
This trial is for adolescents and young adults aged 13-18 who are at clinical high-risk (CHR) for psychosis. Participants must be receiving services from the HOPE team at the University of Pittsburgh and meet specific criteria indicating a risk for developing a psychotic disorder, such as having certain symptoms or family history.Check my eligibility
What is being tested?
The study tests an integrated skills group that combines cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT). It's designed to help those at CHR manage their symptoms. The feasibility and outcomes of this weekly group will be evaluated over approximately 6-7 months.See study design
What are the potential side effects?
Since this intervention involves psychological therapies rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort or distress while discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 13 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months vs up to 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months vs up to 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attendance
Attrition
Change from 4 months in Satisfaction with Therapy and Therapist Scale at up to 7 months
+10 more
Secondary outcome measures
Change from baseline Child and Adolescent Mindfulness Measure at up to 4 months
Change from baseline Child and Adolescent Mindfulness Measure at up to 7 months
Change from baseline Overcontrol/uncontrol word pairs at up to 4 months
+50 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Skills GroupExperimental Treatment1 Intervention
There will be one condition which is the group and participants will complete feasibility and outcome measures at baseline (within 1 month), at midpoint (3-4 months after baseline), and at the end of the group (6-7 months after baseline).

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,726 Previous Clinical Trials
16,305,821 Total Patients Enrolled
2 Trials studying Mental Health
1,469 Patients Enrolled for Mental Health
Substance Abuse and Mental Health Services Administration (SAMHSA)FED
30 Previous Clinical Trials
23,278 Total Patients Enrolled
Leslie Horton, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials

Media Library

Skills Group Clinical Trial Eligibility Overview. Trial Name: NCT05398120 — N/A
Mental Health Research Study Groups: Skills Group
Mental Health Clinical Trial 2023: Skills Group Highlights & Side Effects. Trial Name: NCT05398120 — N/A
Skills Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05398120 — N/A
Mental Health Patient Testimony for trial: Trial Name: NCT05398120 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this research involving human subjects?

"Correct. The clinicaltrials.gov website affirms that this medical research is actively seeking participants, which was originally posted on April 26th 2022 and updated most recently in August 23rd of the same year. Specifically, they are looking for 20 patients at a single site."

Answered by AI

What aims are being pursued by this research?

"The primary measure of efficacy for this clinical trial, assessed over a period up to 6 months from baseline, is Attendance. Secondary outcomes include Change from Baseline in Emotion Regulation Questionnaire (a 10-item scale with higher scores indicating more effective emotion regulation strategies), Change from Baseline in Avoidance Fusion Questionnaire for Youth (17 items on a 1-5 scale representing psychological acceptance), and the Social and Role Functioning Scale (an interview based score ranging 1–10 that reflects social functioning)."

Answered by AI

Who meets the qualifications to participate in this experiment?

"This scientific investigation is seeking 20 adolescents between the ages of 13 and 18 with mental health issues. Eligible participants should be at a clinical high-risk for developing psychotic disorder (Structured Interview for Psychosis-Risk Syndromes scores must range from 3 to 5) or have first degree relatives affected by psychosis, schizotypal personality disorder, or brief intermittent psychotic symptoms. Furthermore, they need to be registered in the HOPE team program hosted by University of Pittsburgh."

Answered by AI

Does this research encompass participants aged 75 or over?

"To be eligible to participate in this research, participants must fall within the age range of 13-18. Currently, there are 115 investigations targeting minors and 270 studies recruiting patients aged 65 or more."

Answered by AI

Is this research project still recruiting participants?

"Affirmative, clinicaltrials.gov confirms that this investigation is currently recruiting participants. This research effort was first posted to the website on April 26th 2022 and last updated August 23rd 2022; they are searching for 20 individuals from a single centre."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
Bellefield Towers
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am interested in mental health research and want to be included in it. I want to use my life experiences to help others.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Are there any compensations?
PatientReceived 2+ prior treatments
~13 spots leftby Jan 2026