Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-15 @ 3:26 PM
Study NCT ID:
NCT05398120
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2022-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skills Group for Youth at Clinical High-Risk for Psychosis
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Testing the Feasibility of a Skills Group for Adolescents and Young Adults at Clinical High-risk for Psychosis
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1 H79 SM081196-01 | OTHER_GRANT | Substance Abuse and Mental Health Services Administration (SAMHSA),PA State Dept/Public Welfare | View |