NCT07225179 mHealth for Early Psychosis Caregivers in Statewide Program Outreach
| NCT ID | NCT07225179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Caregiver |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-12-01 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to pilot the delivery of an mHealth intervention for caregivers to young people with early psychosis within a network of early psychosis intervention programs in the state of North Carolina. The investigators will examine the feasibility of recruitment through program outreach, develop North Carolina specific outreach resources to be used with the mHealth intervention and evaluate the effectiveness of this intervention for reducing caregiver psychological morbidity and improving family communication. The investigators will also collect pilot data to inform recruitment and development of implementation strategies for delivering Bolster within a statewide early psychosis network.
Eligibility Criteria
Inclusion Criteria: * 18 years or older * North Carolina resident * Caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) Being between the ages of 15 and 30, and (2) Within the past five years, the young adult first experienced hallmark symptoms: (2A) Presence of psychotic symptoms represented by one or more of hallucinations, delusions, marked thought disorder, psychomotor disorder or bizarre behavior, as well as (2B) Definite change of personality or behavior manifesting as two or more of the following: serious deterioration of function, marked social withdrawal, persistent self-neglect, episodic marked anxiety. * A positive screen according to the Caregiver Prime Screen - Revised (endorsed two or more responses of five or six ("somewhat"/"definitely" agree) * Own an Apple iPhone * Have access to the internet (e.g., via WiFi or data plan) * Self-identify as a caregiver of the affected person * Are proficient in English to the degree necessary to complete study assessments and engage meaningfully in the intervention Exclusion Criteria: * Participant failed to demonstrate understanding of study details in comprehension screening process. * Previous enrollment in a study involving Bolster. * Activity on screening questionnaires that indicates suspicious or dishonest participation such that the participant is likely to be a "malicious actor" or "gamer" (i.e. an individual that attempts to enroll in online research studies solely for compensation with dishonest or illegitimate responses to study questionnaires)
Contact & Investigator
Ben Buck, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT07225179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Caregiver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07225179 currently recruiting?
Yes, NCT07225179 is actively recruiting participants. Contact the research team at SOM_BolsterNC.smb@ad.unc.edu for enrollment information.
Where is the NCT07225179 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07225179 clinical trial?
NCT07225179 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Ben Buck, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 30 participants.