Feasibility Trial of a Lifestyle Intervention for CHR-P

Not Applicable

Completed

• Conditions: Psychological Disorder; Prodromal Schizophrenia; Psychosis; Psychological Stress
• Interventions: Behavioral: Health Behaviors Group

• Registration Number: NCT05532683
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-08
• Study Start: 2023-04-04
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health Behavior Group	Health Behaviors Group	9- week health behavior promotion group intervention

Primary Outcome Measures

Name	Time	Method
Change in Subjective Stress	Change from baseline (pre-intervention) to 9- week post-intervention	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 in Diet	Change from baseline (pre-intervention) to 9- week post-intervention	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.
Participant Recruitment and Retention	Across Intervention: 9 weeks	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).
Change in Physical Activity	Change from baseline (pre-intervention) to 9- week post-intervention	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 Sleep Habits	Change from baseline (pre-intervention) to 9- week post-intervention	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 in Substance Use	Change from baseline (pre-intervention) to 9- week post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Social Validity as assessed by the Semi-Structured Interview for Social Validation	9-week post-intervention	The social validity of the intervention will be described qualitatively using a modified version of the Semi-Structured Interview for Social Validation. This interview measure includes questions directed at assessing the significance of the goals of the intervention, the acceptability of the procedures used, and the importance of the effects of the intervention. A thematic analysis procedure will be utilized for qualitative analysis of the interviews.

Trial Locations

Locations (1)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States