COMPLETED

Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

Conditions

Caregiver to a Young Adult With Early Psychosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development and Testing of a Caregiver-facing Mobile Health Intervention to Reduce Duration of Untreated Psychosis

Quick Facts

Study Start:2023-08-01

Study Completion:2024-10-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04949542

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Benjamin Buck, PhD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

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

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: University of Washington

Benjamin Buck, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01

Study Completion Date2024-10-04

Study Record Updates

Study Start Date2023-08-01

Study Completion Date2024-10-04

Terms related to this study

Additional Relevant MeSH Terms

Caregiver to a Young Adult With Early Psychosis