Feasibility Trial of a Lifestyle Intervention for CHR-P

NCT ID: NCT05532683

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2024-06-30

Brief Summary

The present study will assess the feasibility and social validity of an adjunctive health promotion group for youth and clinical high risk for psychosis (CHR-P). Youth participating in treatment at the Center for the Assessment and Prevention of Prodromal Sates (CAPPS) will be invited to participate in a weekly, adjunctive, closed psychoeducation group focused on sharing health promotion strategies and increasing health behaviors (e.g. improved sleep habits, increased participation in physical activity).

The aim of the group will be to provide psychoeducation on lifestyle risk and protective factors for youth at risk for psychosis (i.e. experiencing subthreshold psychosis symptoms). Topics covered will include psychoeducation, goal setting, stress management, sleep, physical activity, substance use, and nutrition. Evidence-based strategies to decrease risk factors and promote protective lifestyle factors for mental illness will be reviewed. Group leaders will utilize a motivational interviewing approach to facilitate the group.

The group will complete nine weekly group sessions. The goal of our research is to 1) determine the feasibility of a novel group-based health promotion intervention, 2) assess the social validity of the group, 3) measure the effects of the intervention on stress, sleep, physical activity, substance use, and nutrition, and 4) measure preliminary effects on symptoms and functioning.

Conditions

Prodromal Schizophrenia; Psychosis; Psychological Disorder; Psychological Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Health Behavior Group

9- week health behavior promotion group intervention

Group Type: EXPERIMENTAL

Health Behaviors Group

Intervention Type: BEHAVIORAL

The proposed intervention will include eight modules across nine weekly group sessions targeting psychoeducation of CHR-P symptoms, goal setting, physical activity, sleep, substance use, nutrition, and evidence-based strategies for stress management. Intervention facilitators will utilize motivational interviewing (MI; Miller \& Rollnick, 2012) strategies to engage youth in goal setting to target change in health promotion behaviors. Caregivers will be invited to join at the end of each session for a 10-minute check-out where an outline of content covered and patient goals for the week will be shared.

Interventions

Health Behaviors Group

The proposed intervention will include eight modules across nine weekly group sessions targeting psychoeducation of CHR-P symptoms, goal setting, physical activity, sleep, substance use, nutrition, and evidence-based strategies for stress management. Intervention facilitators will utilize motivational interviewing (MI; Miller \& Rollnick, 2012) strategies to engage youth in goal setting to target change in health promotion behaviors. Caregivers will be invited to join at the end of each session for a 10-minute check-out where an outline of content covered and patient goals for the week will be shared.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. between 13 and 17 years old

2. able to sign and provide informed consent (assent for minors)

3. meet criteria for CHR-P using the Structured Interview for Psychosis-Risk Syndromes (SIPS).

4. Must have a primary caregiver willing to participate who speaks fluent English

Exclusion Criteria

1. current or lifetime DSM-5 psychotic disorder

2. impaired intellectual functioning (IQ <65)

3. history of neurological disorder

4. traumatic brain injury (≥7 on TBI screening tool)

5. significant substance use that makes CHR-P diagnosis ambiguous

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Bernalyn Ruiz-Yu, PhD

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

IRB#22-001116

Identifier Type: -

Identifier Source: org_study_id