Skip to main content
OpenTrials
Completed

NCT Number: NCT05532683

Feasibility Trial of a Lifestyle Intervention for CHR-P

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prodromal Schizophrenia Behavior Behavioral Symptoms Health Behavior Mental Disorders Personality Disorders Psychological Disorder Psychological Stress Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Schizotypal Personality Disorder Stress, Psychological

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.