Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

NCT04949542 | Completed Results DMC

• 1 other identifier: STUDY00013334
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver to a Young Adult With Early Psychosis

Outcome Measures

Primary Outcomes (4)

• Change in Family Communication

  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, we 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, 6 weeks, 12 weeks

• Change in Treatment Facilitation

  Treatment seeking will be measured using the Measure to Assess Steps to Service-Caregivers (MASS-CG). The MASS-CG is a 23-item self-report assessment of steps taken by the caregiver towards the attainment of mental health treatment for their loved one, including research, social support, encouragement or support of the loved one's help-seeking actions, and engagement with service provider steps. Each item is endorsed on a three-point Likert scale (0 = No, I have not done this, 1 = I have done this once or twice, 2 = I have done this multiple times). The MASS-CG is scored by summing individual items with higher scores indicating greater levels of treatment facilitation activities.

  Baseline, 6 weeks, 12 weeks

• Change in Loved One Treatment Engagement, Medication Provider

  Treatment facilitation / duration of untreated psychosis will be assessed according to participants' report of appointments attended by their relative in the past during the treatment period. This first category includes meeting with a clinician providing psychiatric medications. At screening, participants report treatment engagement over the previous three months and during the study period, participants are asked to report on this weekly. This count variable represents the number of participants who reported that their loved one attended an appointment with a medication provider in the three months preceding the study period reported at screening ("Baseline") as well as for the duration of the study period reported in weekly brief assessments ("12 weeks"). The 12 week data point includes participants who completed at least half of the weekly brief assessments.

  Baseline, 12 weeks

• Change in Loved One Treatment Engagement, Therapy or Counseling

  Treatment facilitation / duration of untreated psychosis will be assessed according to participants' report of appointments attended by their relative in the past during the treatment period. This first category includes meeting with a clinician providing mental health therapy or counseling. At screening, participants report treatment engagement over the previous three months and during the study period, participants are asked to report on this weekly. This count variable represents the number of participants who reported that their loved one attended an appointment for psychotherapy or counseling in the three months preceding the study period reported at screening ("Baseline") as well as for the duration of the study period reported in weekly brief assessments ("12 weeks"). The 12 week data point includes participants who completed at least half of the weekly brief assessments.

  Baseline, 12 weeks

Secondary Outcomes (9)

• Change in Illness Knowledge, Factual Knowledge

  Baseline, 6 weeks, 12 weeks

• Change in Illness Knowledge, Caregiver Self-rated

  Baseline, 6 weeks, 12 weeks

• Change in Illness Appraisals, Consequences

  Baseline, 6 weeks, 12 weeks

• Change in Illness Appraisals, Control

  Baseline, 6 weeks, 12 weeks

• Change in Illness Appraisals, Emotional Distress About Illness

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

Bolster

EXPERIMENTAL

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.

Behavioral: Bolster

Control

OTHER

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.

Behavioral: Control

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.

Bolster

Control BEHAVIORAL

Exemplar resources provided in the control arm will include a selection from the National Alliance on Mental Illness and Mental Health America designed to support caregivers helping loved ones access care.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Behavioral Research in Technology and Engineering Center, Health Sciences, UW Medical Center

Seattle, Washington, 98195, United States

Location

Results Point of Contact

• Title: Dr. Benjamin Buck, Associate Professor
• Organization: University of Washington (affiliate) / University of North Carolina at Chapel Hill

buckbe@uw.edu

(919) 445-4330

Study Officials

• Benjamin Buck, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: School of Medicine: Psychiatry

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 2, 2021
• Study Start: August 11, 2023
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Locations

US (1)