Bolster for Caregivers of Early Psychosis

(Bolster-NC Trial)

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Failed comprehension, Previous Bolster, Dishonest participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called Bolster, designed to assist caregivers of young people with early psychosis. The goal is to determine if the app can reduce caregiver stress and improve family communication. The trial seeks participants in North Carolina who care for a young adult showing early signs of psychosis, such as hallucinations or significant behavioral changes. Participants need an iPhone and internet access to join. As an unphased trial, this study offers caregivers a unique opportunity to contribute to innovative research that could enhance support for families managing early psychosis.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on caregivers rather than the individuals with early psychosis, so your current medications may not be relevant to participation.

What prior data suggests that this mHealth intervention is safe for caregivers?

Research has shown that Bolster, a mobile health app, is designed to assist caregivers of young people with early psychosis. The app aims to provide support and enhance caregiving skills. Although specific safety data is not yet available, as a digital tool, Bolster generally poses less risk than medications or medical devices.

The app underwent testing to ensure ease of use and was developed with input from the caregivers it supports. This focus on user needs helps ensure safety and simplicity. As a non-invasive digital app, no negative effects have been reported.

Overall, Bolster appears to be well-received, aiming to ease caregiving without posing safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bolster smartphone application because it offers a unique support system specifically designed for caregivers of young adults with early psychosis. Unlike traditional treatments that focus primarily on the patient, Bolster acknowledges the crucial role of caregivers by providing them with tailored resources and direct access to support from the research team. This approach aims to empower caregivers, potentially improving the overall management of the condition by fostering a more supportive environment for both the caregivers and those they care for.

What evidence suggests that the Bolster mHealth intervention is effective for reducing caregiver psychological morbidity and improving family communication?

Research shows that Bolster, a mobile health app, could greatly assist caregivers of young adults with early psychosis. Studies have found that caregivers consider Bolster easy to use and beneficial. Early results suggest it can reduce stress and enhance family communication. Apps like Bolster have been linked to better management of early psychosis symptoms, such as unusual thoughts and behaviors. By providing quick access to support, digital health tools like Bolster can help caregivers feel more prepared to handle challenges. Overall, initial findings suggest that Bolster may effectively aid caregivers in managing early psychosis. ^{3 6 7 8 9}

Who Is on the Research Team?

Ben Buck, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for caregivers of young individuals with early psychosis in North Carolina. It aims to help those experiencing stress or burnout from caregiving. Participants should be involved in a network of early psychosis intervention programs within the state.

Inclusion Criteria

North Carolina resident

Caregiver to a young adult with early psychosis meeting specific criteria

A positive screen according to the Caregiver Prime Screen - Revised

Exclusion Criteria

Participant failed comprehension screening process

Activity indicating suspicious or dishonest participation

I have previously participated in a study involving Bolster.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Baseline Assessment

Participants are recruited and complete baseline measures before accessing the mHealth intervention

2 weeks

Remote recruitment and baseline assessment

Intervention

Participants access the Bolster mHealth intervention, which provides self-guided psychoeducation and communication coaching

12 weeks

Remote access to intervention

Follow-up

Participants are monitored for changes in caregiver psychological morbidity and family communication

4 weeks

Remote follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Bolster

Trial Overview The study tests 'Bolster', an mHealth (mobile health) intervention designed to support caregivers. The focus is on its feasibility, developing local resources, and assessing its impact on reducing caregiver stress and improving family communication.

How Is the Trial Designed?

Group I: Bolster Experimental Treatment 1 Intervention

Participants 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

North Carolina Department of Health and Human Services

Collaborator

Trials

15

Recruited

94,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10722359/

User-Centered Development of Bolster, an mHealth ... The aim of this study was to conduct user-centered design and testing of an mHealth intervention to support early psychosis caregivers.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S092099642500372X

Pilot randomized controlled trial of Bolster, an mHealth ... Results suggest that Bolster is acceptable to caregivers and has promising preliminary efficacy. Introduction. Caregivers are critical to the effectiveness of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04657380

A Mobile Application to Improve Case-management and ... First Episode Psychosis (FEP) includes perceptual distortions, delusions and cognitive impairment with severe consequences, such as suicidal behaviour.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1137644/pdf

Mobile health in the specific management of first-episode ... Overall, the studies to date suggest promising preliminary efficacy data on the use of mobile applications in early psychosis. Given the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11638689/

Digital Health Interventions for Informal Family Caregivers of ... Digital health interventions offer the possibility to access help quicker, use less resources, and improve informal family caregiver outcomes.

6. mental.jmir.org mental.jmir.org/2023/1/e50522/

User-Centered Development of Bolster, an mHealth ... Conclusions: To our knowledge, this study is the first to design an mHealth intervention specifically for early psychosis caregivers.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04949542

Caregiver App to Reduce Duration of Untreated Psychosis 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 ...

8. trialx.com trialx.com/clinical-trials/listings/235842/bolster-caregiver-app-to-reduce-duration-of-untreated-psychosis/

Caregiver App to Reduce Duration of Untreated Psychosis Clinical trial for Caregiver to a Young Adult With Early Psychosis , Bolster: Caregiver App to Reduce Duration of Untreated Psychosis.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996425001938

Smartphone monitoring and digital phenotyping apps for ... This review systematically examines unique datasets generated from unique apps for schizophrenia-spectrum disorders.