Clinical trial NCT05532683: Feasibility Trial of a Lifestyle Intervention for CHR-P
Official title: Development and Feasibility of a Lifestyle Group Intervention for Youth at Clinical High Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prodromal Schizophrenia
Psychosis
Psychological Disorder
Psychological Stress
Keywords: early intervention
lifestyle intervention
clinical high risk for psychosis
health behavior
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 9
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Participant Recruitment and Retention
timeFrame: Across Intervention: 9 weeks
measure: Change in Physical Activity
timeFrame: Change from baseline (pre-intervention) to 9- week post-intervention
measure: Change Sleep Habits
timeFrame: Change from baseline (pre-intervention) to 9- week post-intervention
measure: Change in Subjective Stress
timeFrame: Change from baseline (pre-intervention) to 9- week post-intervention
measure: Change in Substance Use
timeFrame: Change from baseline (pre-intervention) to 9- week post-intervention
measure: Change in Diet
timeFrame: Change from baseline (pre-intervention) to 9- week post-intervention
Secondary outcomes:
measure: Social Validity as assessed by the Semi-Structured Interview for Social Validation
timeFrame: 9-week post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References: