Prodromal SchizophreniaNCT05532683
Feasibility Trial of a Lifestyle Intervention for CHR-P
A study testing Health Behaviors Group in people with Prodromal Schizophrenia and Psychosis, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Prodromal Schizophrenia, Psychosis, Psychological Disorder
- What is being tested?
- Health Behaviors Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Official title: Development and Feasibility of a Lifestyle Group Intervention for Youth at Clinical High Risk for Psychosis
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.
- Being tested
- Health Behaviors Group
- Keywords
- early intervention, lifestyle intervention, clinical high risk for psychosis, health behavior
- Medical subject headings
- Schizotypal Personality Disorder, Psychotic Disorders, Mental Disorders, Stress, Psychological, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Behaviors GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Behavior Group | Experimental | 9- week health behavior promotion group intervention Receives: Behavioral: Health Behaviors Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Across Intervention: 9 weeks
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.
Measured: Change from baseline (pre-intervention) to 9- week post-intervention
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.
Measured: Change from baseline (pre-intervention) to 9- week post-intervention
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.
Measured: Change from baseline (pre-intervention) to 9- week post-intervention
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.
Measured: Change from baseline (pre-intervention) to 9- week post-intervention
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.
Measured: Change from baseline (pre-intervention) to 9- week post-intervention
Secondary outcomes (1)
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.
Measured: 9-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start4 Apr 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernalyn Ruiz-Yu, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532683
- Sponsor's protocol ID
- IRB#22-001116
- Status last verified
- Jul 2024
- First submitted
- 1 Aug 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Treatment manual will also be made available. Proposals should be directed to bernalynruiz@mednet.ucla.edu. To gain access, data requestors will need to sign a data access agreement and provide methodologically sound research proposal.
Publications
Ruiz-Yu B, Diaz T, Hernandez D, Zinberg J, Miklowitz DJ, Bearden CE. Feasibility Trial of a Health Behaviours Promotion Group for Youth at Clinical High Risk for Psychosis. Early Interv Psychiatry. 2026 Aug;20(8):e70231. doi: 10.1111/eip.70231.
PubMed 42552232
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility of a Lifestyle Group Intervention for Youth at Clinical High Risk for Psychosis
- ClinicalTrials.gov ID
- NCT05532683
- Acronym / sponsor ID
- IRB#22-001116
- Keywords
- early intervention, lifestyle intervention, clinical high risk for psychosis, health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Health Behavior Group | Experimental | Behavioral: Health Behaviors Group9- week health behavior promotion group intervention |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Behaviors GroupThe 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. | Behavioural | Health Behavior Group |
Primary outcome
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 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 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.
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.
1 secondary outcome
Social Validity as assessed by the Semi-Structured Interview for Social Validation
Time frame: 9-week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Derived from this study: PubMed 42552232Ruiz-Yu B, Diaz T, Hernandez D, Zinberg J, Miklowitz DJ, Bearden CE. Feasibility Trial of a Health Behaviours Promotion Group for Youth at Clinical High Risk for Psychosis. Early Interv Psychiatry. 2026 Aug;20(8):e70231. doi: 10.1111/eip.70231.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Treatment manual will also be made available. Proposals should be directed to bernalynruiz@mednet.ucla.edu. To gain access, data requestors will need to sign a data access agreement and provide methodologically sound research proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Behaviors Group in people with Prodromal Schizophrenia and Psychosis, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment and Retention (time frame: Across Intervention: 9 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05532683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.