Clinical trial NCT04949542: Bolster: Caregiver App to Reduce Duration of Untreated Psychosis
Official title: Development and Testing of a Caregiver-facing Mobile Health Intervention to Reduce Duration of Untreated Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver to a Young Adult With Early Psychosis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed research project aims to develop and test a mobile health intervention designed to improve caregivers' illness knowledge and caregiving skills through interactive cognitive-behavioral modules, and through these improvements, reduce distress, improve coping, improve family communication, increase caregiver treatment facilitation and reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial comparing this new intervention to existing online caregiving support resources. Analyses will determine whether this approach is acceptable and feasible, as well as explore its effectiveness and impact on key components of the cognitive model of caregiving.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Live in the United States
* Caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) Being between the ages of 18 and 30, and (2) Within the past five years, the young adult first experienced: (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
* Self-identify as a caregiver of the affected person
* The affected person is not enrolled in specialty mental health services (i.e. a program wherein the affected person can access psychiatry and counseling/therapy services), and has not been enrolled in such services for at least three months prior to screening. If an affected person is receiving one of these services, the caregiver reports that this is an inadequate level of care.

Exclusion Criteria:

* Incarceration or long-term care setting for either the caregiver or identified affected young adult.
* Participant failed to demonstrate understanding of study details in comprehension screening process.
* The affected person is unengaged in services, but only as a result of having completed or "graduated" from a specialty treatment program for psychosis.

Primary outcomes:
measure: Change in family communication
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in treatment facilitation
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in treatment engagement, general
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in treatment engagement, specialty
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Change in illness knowledge, factual knowledge
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in illness knowledge, caregiver self-rated
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in illness appraisals, consequences
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in illness appraisals, control
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in illness appraisals, emotional distress about illness
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in caregiving experiences
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in caregiver coping, activities
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in caregiver coping, self-efficacy
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in caregiver distress
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Behavioral Research in Technology and Engineering Center, Health Sciences, UW Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Benjamin Buck, PhD
role: PRINCIPAL_INVESTIGATOR
References: