Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

University of Washington

Status: Completed

Conditions: Caregiver to a Young Adult With Early Psychosis

Treatments: Behavioral: Bolster; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04949542

STUDY00013334

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 15 and 35, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Bolster

Experimental group

Description:

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

Treatment:

Behavioral: Bolster

Control

Other group

Description:

Participants in the control condition will be provided support resources from mental health advocacy organizations representing currently available resources for caregivers (including a selection from the National Alliance on Mental Illness and Mental Health America). They will also have access to the research team by phone for technical troubleshooting and support as necessary.

Treatment:

Behavioral: Control