Feasibility Trial of a Lifestyle Intervention for CHR-P

NCT05532683 | Completed

• 1 other identifier: IRB#22-001116
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Keywords

early intervention; lifestyle intervention; clinical high risk for psychosis; health behavior

Outcome Measures

Primary Outcomes (6)

• Participant Recruitment and Retention

  Feasibility will be measured by recruitment (participants approached/ participants enrolled) and retention (participants enrolled/ participants completed at least two-thirds of the intervention). Feasibility data will be summarized by the percent recruited, the percent retained by group and the mean and median number of sessions attended by group. The percent who attended each session by group over time will also be reported. Good feasibility will be defined as 70% of those enrolled completing at least two-thirds of the intervention (6 sessions).

  Across Intervention: 9 weeks

• Change in Physical Activity

  The mean profile from baseline to post-treatment for physical activity as assessed by the International Physical Activity Questionnaire - Short Form (IPAQ-SF; Craig et al., 2017). Activity levels will be self-report.

  Change from baseline (pre-intervention) to 9- week post-intervention

• Change Sleep Habits

  Sleep will be assessed via self-report on the PROMIS Pediatric Sleep Disturbance scale (Buysse, et al., 2010). The Pediatric Sleep Disturbance Scale consists of 15 items rated 1 = Never, 2 = Almost Never, 3 = Sometimes, 4 = Almost Always, and 5 = Always, with a higher score indicating more sleep disturbance.

  Change from baseline (pre-intervention) to 9- week post-intervention

• Change in Subjective Stress

  Participant subjective stress will be assessed via the 10-item self-report Perceived Stress Scale ( PSS; Cohen et al., 1983).The PSS consists of 10 items rated 0= Never to 4= Very Often, with a higher score suggesting more stress.

  Change from baseline (pre-intervention) to 9- week post-intervention

• Change in Substance Use

  Alcohol and drug use will be measured by clinician rated on the Alcohol Use Scale and Drug Use Scale (AUS/DUS; Drake et al., 1996). This measure rates frequency and impairment associated with alcohol and drug use. Alcohol and drug use are rated on both frequency (0= no use to 5= almost daily) and impairment (0= abstinent to 5= dependence with institutionalization). A rating of 3 or higher on impairment corresponds with substance use disorder.

  Change from baseline (pre-intervention) to 9- week post-intervention

• Change in Diet

  Change in diet will be measured on the ASA24. This dietary assessment uses 24-hour recall to assess nutrition quality and provides measure of total energy intake and macronutrients.

  Change from baseline (pre-intervention) to 9- week post-intervention

Secondary Outcomes (1)

• Social Validity as assessed by the Semi-Structured Interview for Social Validation

  9-week post-intervention

Study Arms (1)

Health Behavior Group

EXPERIMENTAL

9- week health behavior promotion group intervention

Behavioral: Health Behaviors Group

Interventions

Health Behaviors Group 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.

Health Behavior Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• between 13 and 17 years old
• able to sign and provide informed consent (assent for minors)
• meet criteria for CHR-P using the Structured Interview for Psychosis-Risk Syndromes (SIPS).
• Must have a primary caregiver willing to participate who speaks fluent English

You may not qualify if:

• current or lifetime DSM-5 psychotic disorder
• impaired intellectual functioning (IQ \<65)
• history of neurological disorder
• traumatic brain injury (≥7 on TBI screening tool)
• significant substance use that makes CHR-P diagnosis ambiguous

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Schizotypal Personality Disorder; Psychotic Disorders; Mental Disorders; Stress, Psychological; Health Behavior

Condition Hierarchy (Ancestors)

Personality Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Model Details: One group of 12 participants identified as at clinical high-risk for psychosis (CHR-P) will be recruited to participate in a 9-week health behavior promotion/lifestyle intervention.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: September 8, 2022
• Study Start: April 4, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Those requesting access should have Ph.D. or equivalent level degree in psychology or a related field. Researchers should also provide a methodologically sound proposal.

Locations

US (1)