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Clinical Trials/NCT05532683
NCT05532683
Completed
Not Applicable

Development and Feasibility of a Lifestyle Group Intervention for Youth at Clinical High Risk for Psychosis

University of California, Los Angeles1 site in 1 country9 target enrollmentApril 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prodromal Schizophrenia
Sponsor
University of California, Los Angeles
Enrollment
9
Locations
1
Primary Endpoint
Change in Subjective Stress
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2023
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bernalyn Ruiz-Yu, PhD

Postdoctoral Fellow

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in Subjective Stress

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Social Validity as assessed by the Semi-Structured Interview for Social Validation(9-week post-intervention)

Study Sites (1)

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