Clinical trial NCT05398120: Skills Group for Youth At Clinical High-Risk for Psychosis
Official title: Testing the Feasibility of a Skills Group for Adolescents and Young Adults At Clinical High-risk for Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinical High-Risk
Psychological
Keywords: Group intervention
Dialectical behavioral therapy skills
Cognitive behavioral therapy skills
Psychosis-risk
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2022-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants already receiving services in the psychosis-risk clinic at the University of Pittsburgh will be asked to participate in the psychosis-risk 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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Attrition
timeFrame: Up to 5 months
measure: Attendance
timeFrame: Up to 5 months
measure: Modified Quick Lecomte and Leclerc Scale
timeFrame: Up to 5 months
measure: Participation Scale
timeFrame: Up to 5 months
measure: Change from baseline in the participant group survey at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in the participant group survey at up to 5 months
timeFrame: Up to 3 months vs up to 5 months
measure: Change from baseline in the participant group survey at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Satisfaction with Therapy and Therapist Scale at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from 3 months in Satisfaction with Therapy and Therapist Scale at up to 5 months
timeFrame: Up to 3 months vs. up to 5 months.
measure: Fidelity scores
timeFrame: Up to 5 months
Secondary outcomes:
measure: Change from baseline in Lehman Quality of Life Functional Assessment at up to 3 months.
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Lehman Quality of Life Functional Assessment at up to 5 months.
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Lehman Quality of Life Functional Assessment at up to 5 months.
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Perceived Stress Scale at up to 3 months
timeFrame: Baseline to up to 3 months
measure: Change from up to 3 months in Perceived Stress Scale at up to 5 months.
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Perceived Stress Scale at up to 5 months.
timeFrame: Baseline to up to 5 months
measure: Change from baseline in Cognitive Insight Scale at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Cognitive Insight Scale at up to 5 months.
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Cognitive Insight Scale at up to 5 months.
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Defeatist Performance Attitudes at up to 3 months
timeFrame: Baseline vs. Up to 3 months
measure: Change from up to 3 months in Defeatist Performance Attitudes at up to 5 months.
timeFrame: Up to 3 months vs up to 5 months
measure: Change from baseline in Defeatist Performance Attitudes at up to 5 months.
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Avoidance Fusion Questionnaire for Youth at up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Social and Role Functioning Scale at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Social and Role Functioning Scale at up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Social and Role Functioning Scale at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change in symptoms from baseline Structured Interview for Psychosis-Risk Syndromes and/or Mini interview (abbreviated version) to up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: 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
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in the Structured Interview for Psychosis-Risk Syndromes interview and/or Mini interview (abbreviated version) at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Negative Symptom Inventory Psychosis-Risk at up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Beck Depression Inventory to up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Beck Depression Inventory to up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Beck Depression Inventory to up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Beck Anxiety Inventory at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Beck Anxiety Inventory at up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Beck Anxiety Inventory at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Child Trauma Questionnaire
timeFrame: Baseline
measure: Change from baseline Child and Adolescent Mindfulness Measure at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months Child and Adolescent Mindfulness Measure at up to 5 months
timeFrame: up to 3 months vs. up to 5 months
measure: Change from baseline Child and Adolescent Mindfulness Measure at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Emotion Regulation Questionnaire at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Emotion Regulation Questionnaire at up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Emotion Regulation Questionnaire at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change from baseline in Social Connectedness Scale at up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change from up to 3 months in Social Connectedness Scale at up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change from baseline in Social Connectedness Scale at up to 5 months
timeFrame: Baseline vs. up to 5 months
measure: Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 3 months
timeFrame: Baseline vs. up to 3 months
measure: Change in Internalized Stigma Mental Illness Inventory (ISMI) from up to 3 months to up to 5 months
timeFrame: Up to 3 months vs. up to 5 months
measure: Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 5 months
timeFrame: Baseline vs. up to 5 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Bellefield Towers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Leslie Horton, PhD
role: PRINCIPAL_INVESTIGATOR
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