mHealth for Early Psychosis Caregivers in Statewide Program Outreach

Официальное название

Bolster-NC: A Pilot Study of the Bolster mHealth Intervention Within Early Psychosis Program Outreach in North Carolina

Обзор

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.

Подробное описание

The team aims to pilot test 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. This will involve (1) examining the feasibility of recruitment through program outreach, (2) developing and optimizing state-specific outreach resources and recruitment approaches to be implemented for this mHealth intervention, and (3) evaluating the effectiveness of this intervention in reducing caregiver psychological morbidity and improving family communication. Participants will be caregivers to young people experiencing early psychosis within the state of North Carolina. Remote recruitment resources will be developed and distributed through the EPI-NC outreach program (i.e. network of UNC-based early psychosis clinicians and stakeholders aiming to raise awareness of early psychosis and specialty programs). Recruited participants will complete baseline measures and be given access to the Bolster mHealth intervention, which provides self-guided psychoeducation and communication coaching for early psychosis caregivers. The investigators will collect baseline and post-test data and evaluate within-subjects changes in proposed targets and outcomes including primary outcomes of caregiver psychological morbidity and family communication.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

• Change in illness knowledge [Срок оценки: Baseline, 12 weeks]
• Change in emotional distress about illness [Срок оценки: Baseline, 12 weeks]
• Change in coping self-efficacy [Срок оценки: Baseline, 12 weeks]
• Change in appraisals of caregiving experiences [Срок оценки: Baseline, 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UNC Department of Psychiatry — Chapel Hill

Идентификаторы

NCT: NCT07225179 · 25-1793

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗