Skills Group for Youth at Clinical High-Risk for Psychosis

University of Pittsburgh

Status: Enrolling

Conditions: Clinical High-Risk; Psychological

Treatments: Behavioral: Skills Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05398120

1 H79 SM081196-01 (Other Grant/Funding Number)

STUDY21120012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Skills Group

Experimental group

Description:

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.

Treatment:

Behavioral: Skills Group