N/A
N=60
Bolster: Caregiver App to Reduce Duration of Untreated Psychosis
Caregiver to a Young Adult With Early Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT04949542 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Family Communication — 58.94; 56.66; 53.23; 53.20 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bolster (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Family Communication |
58.94; 56.66; 53.23; 53.20; 52.02; 53.55 | — |
| PRIMARY Change in Treatment Facilitation |
22.47; 24.29; 18.79; 16.60; 20.08; 19.54 | — |
| PRIMARY Change in Loved One Treatment Engagement, Medication Provider |
15; 8; 21; 7 | — |
| PRIMARY Change in Loved One Treatment Engagement, Therapy or Counseling |
17; 8; 24; 8 | — |
| SECONDARY Change in Illness Knowledge, Factual Knowledge |
15.90; 15.65; 16.16; 16.15; 16.08; 15.63 | — |
| SECONDARY Change in Illness Knowledge, Caregiver Self-rated |
13.40; 11.35; 10.97; 10.96; 10.92; 10.58 | — |
| SECONDARY Change in Illness Appraisals, Consequences |
79.63; 80.90; 76.13; 79.77; 75.93; 80.39 | — |
| SECONDARY Change in Illness Appraisals, Control |
30.06; 31.70; 30.65; 31.80; 31.46; 31.63 | — |
| SECONDARY Change in Illness Appraisals, Emotional Distress About Illness |
34.74; 31.85; 30.63; 32.55; 29.64; 32.11 | — |
| SECONDARY Change in Appraisal of Caregiving Experiences** |
43.04; 45.77; 40.11; 42.70; 37.94; 42.76 | — |
| SECONDARY Change in Caregiver Coping, Activities |
35.32; 37.25; 36.07; 34.72; 36.81; 36.84 | — |
| SECONDARY Change in Caregiver Coping, Self-efficacy |
135.23; 142.23; 154.86; 149.25; 168.99; 160.84 | — |
| SECONDARY Change in Caregiver Distress |
19.00; 18.45; 14.14; 17.75; 11.67; 15.68 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT04949542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.