Digital (Bolster) support for caregivers of young people with early psychosis in North Carolina
Bolster-NC: A Pilot Study of the Bolster mHealth Intervention Within Early Psychosis Program Outreach in North Carolina
This pilot will try the Bolster mobile app to reduce caregiver stress and improve family communication for North Carolina caregivers of young adults with early psychosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07225179 on ClinicalTrials.gov |
What this trial studies
The study will deliver the Bolster mHealth app to caregivers through a statewide network of early psychosis programs (EPI‑NC) and develop North Carolina–specific outreach materials. Recruitment will occur remotely via program outreach and enrolled caregivers will complete baseline and post-test measures. Bolster provides self-guided psychoeducation and communication coaching tailored for early psychosis caregivers. The team will analyze within-subject changes in caregiver psychological distress and family communication to inform statewide implementation strategies.
Who should consider this trial
Good fit: Ideal participants are English-proficient North Carolina residents aged 18 or older who self-identify as a caregiver to a young person (age 15–30) within five years of first psychotic symptoms, screen positive on the Caregiver Prime Screen – Revised, and own an Apple iPhone with internet access.
Not a fit: Caregivers who do not live in North Carolina, who lack an Apple iPhone or internet access, who are not English proficient, or whose loved one does not meet the early psychosis definition are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the app could lower caregiver psychological distress and improve family communication by offering accessible, tailored coaching and education.
How similar studies have performed: Prior mHealth and psychoeducational programs for caregivers have shown mixed but promising results for reducing distress and improving communication, while delivering Bolster at a statewide scale is a novel application.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Chapel Hill, North Carolina
- UNC Department of Psychiatry — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ben Buck, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Research Coordinator
- Email: SOM_BolsterNC.smb@ad.unc.edu
- Phone: 8284050588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.