Feasibility Trial of a Lifestyle Intervention for CHR-P

Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05532683
• Other study ID #: IRB#22-001116
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: July 31, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Prodromal Schizophrenia
• Psychological Disorder
• Psychological Stress
• Psychosis
• Psychotic Disorders
• Schizophrenia
• Stress, Psychological

Intervention

Behavioral:
• Health Behaviors Group
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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Social Validity as assessed by the Semi-Structured Interview for Social Validation	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.	9-week post-intervention