Recruiting

Bolster

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07225179

Conditions

Caregiver

Caregiver Distress

Caregiver to a Young Adult With Early Psychosis

Family Caregivers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bolster

Study Details

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.

Conditions

Caregiver

Caregiver Distress

Caregiver to a Young Adult With Early Psychosis

Family Caregivers

Study ID

NCT07225179

Start date

Dec 1, 2025

Status verified date

Nov, 2025

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bolster

Participants will be provided access to the Bolster smartphone application designed to support caregivers of young adults with early psychosis. They will also have access to the research team by phone for technical troubleshooting and support as necessary.

Interventions

Bolster

Bolster is a native mobile app that provides on-demand content to caregivers of young adults with early psychosis to support their caregiving skills and knowledge of psychosis. Participants will also have access to a member of the study team for technical troubleshooting and support as necessary.

Primary outcome measure

  • Change in family communication / expressed emotion [ Time Frame: Baseline, 12 weeks ]
  • Change in caregiver psychological morbidity [ Time Frame: Baseline, 12 Weeks ]

Central Contacts and Locations

Central contacts

Research Coordinator

8284050588SOM_BolsterNC.smb@ad.unc.edu

Locations

UNC Department of Psychiatry

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

David Rauscher

919-348-9779‬bolster_nc@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 27, 2026

Last verified

Nov, 2025

Keywords

  • Caregiver
  • Caregiver Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-05-27.