mHealth for Early Psychosis Caregivers in Statewide Program Outreach

NCT07225179 | Recruiting

• 1 other identifier: 25-1793
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Caregiver; Caregiver Support

Outcome Measures

Primary Outcomes (2)

• Change in family communication / expressed emotion

  Family communication will be assessed with the Family Questionnaire (FQ). The FQ is a 20-item self-report assessment of criticism and emotional expression in interactions with family members toward patients with mental illness. Each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The FQ is scored by summing individual items with higher scores indicating greater levels of expressed emotion. As a primary outcome, the investigators will examine the combined total of emotional overinvolvement and critical comments; scores range from 20 to 80 with higher scores indicating greater expressed emotion.

  Baseline, 12 weeks

• Change in caregiver psychological morbidity

  Caregiver psychological morbidity will be assessed with General Health Questionnaire (GHQ), a 12-item questionnaire assessing general psychological morbidity. Respondents indicate agreement on a four-point scale (0 = Not at all; 3 = More than usual) and total scores ranging from 0 to 36 with higher scores indicating more severe psychological morbidity.

  Baseline, 12 Weeks

Secondary Outcomes (4)

• Change in illness knowledge

  Baseline, 12 weeks

• Change in emotional distress about illness

  Baseline, 12 weeks

• Change in coping self-efficacy

  Baseline, 12 weeks

• Change in appraisals of caregiving experiences

  Baseline, 12 weeks

Study Arms (1)

Bolster

EXPERIMENTAL

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.

Behavioral: Bolster

Interventions

Bolster BEHAVIORAL

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.

Bolster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Department of Health and Human Services: collaborator

Study Sites (1)

UNC Department of Psychiatry

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Study Officials

• Ben Buck, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

8284050588; SOM_BolsterNC.smb@ad.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment.

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 6, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 12 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)