mHealth for Early Psychosis Caregivers in Statewide Program Outreach

Recruiting now · Not applicable

Conditions studied: Caregiver, Caregiver Distress, Caregiver to a Young Adult With Early Psychosis, Family Caregivers

In brief

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.

Key facts

Study ID

NCT07225179

Run by

University of North Carolina, Chapel Hill

People needed

30

Starts

2025-12-01

Expected to finish

2027-07-30

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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)

Where it is running

• UNC Department of Psychiatry — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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