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Behavioral Intervention

Bolster App for Psychosis Caregivers

N/A

Recruiting

Led By Ben Buck, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of psychotic symptoms represented by one of the following

Being between the ages of 18 and 30,

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12 weeks

Awards & highlights

Study Summary

This trial aims to develop and test a mobile health intervention to improve caregiver knowledge, skills and communication, and reduce untreated psychosis.

Who is the study for?

This trial is for caregivers of young adults aged 18-30 who are experiencing early psychosis, which can include hallucinations, delusions, severe anxiety, or social withdrawal. Caregivers must be looking to improve their caregiving skills and knowledge about mental illness.Check my eligibility

What is being tested?

The study tests a mobile app called Bolster against standard online resources. The app aims to educate caregivers with interactive modules on how to better support their loved ones and potentially shorten the time the young adult goes without treatment.See study design

What are the potential side effects?

Since this trial involves educational resources rather than medication, traditional side effects are not expected. However, participants may experience an emotional impact from engaging with the material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience symptoms like hallucinations or delusions.

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I am between 18 and 30 years old.

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I experience hallucinations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in family communication

Change in treatment engagement, general

Change in treatment engagement, specialty

+1 more

Secondary outcome measures

Change in caregiver coping, activities

Change in caregiver coping, self-efficacy

Change in caregiver distress

+6 more

Other outcome measures

Intervention acceptability / usability

Intervention feasibility

Trial Design

2Treatment groups

Experimental Treatment

Group I: ControlExperimental Treatment1 Intervention

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.

Group II: BolsterExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control

2011

Completed Phase 4

~15780

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,700 Total Patients Enrolled

Ben Buck, PhDPrincipal InvestigatorUniversity of Washington

Benjamin Buck, PhDPrincipal InvestigatorUniversity of Washington

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are engaging in this research?

"Affirmative, the information located on clinicaltrials.gov supports that this research endeavor is actively recruiting patients. The investigation was created on August 1st 2023 and subsequently updated November 17th 2023. Altogether, 60 test subjects must be recruited from a single centre."

Answered by AI

Is it feasible to join this medical experiment?

"To qualify for this study, the primary caretaker of a young adult between 18 and 80 suffering from early psychosis is required. The total number of participants to be recruited is 60."

Answered by AI

Are there open spots available for interested participants in this clinical trial?

"As per the official information on clinicaltrials.gov, this research is actively recruiting participants at present. This trial was first posted online in August 1st 2023 and its details were last amended on November 17th 2023."

Answered by AI

Does this trial extend its parameters to those aged eighty or above?

"As indicated by the study's inclusion criteria, individuals aged between 18 and 80 are eligible to partake in this clinical trial. Additionally, there are 124 trials for minors and 287 for seniors."

Answered by AI

What is the purpose of this experimental research?

"This trial, which will be monitored over Baseline, 6 weeks, and 12 weeks intervals respectively, seeks to assess Changes in treatment engagement at a general level. Additionally, secondary objectives include changes in illness knowledge (measured by the Knowledge About Schizophrenia assessment), caregiver-rated self-perception of illness knowledge (as per Illness Perception Questionnaire for Schizophrenia Relatives) as well as appraisals of consequences resulting from an illnesses (also evaluated via IPQ)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bolster: Caregiver App to Reduce Duration of Untreated Psychosis

Benjamin Buck 2023. "Bolster: Caregiver App to Reduce Duration of Untreated Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04949542.