Mobile App Psychological Interventions for Dementia Caregivers

Overseen By Felipe A Jain, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Psychosis, Mania, Suicide attempt, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help family caregivers of people with dementia manage stress and improve their mental health. It tests a mobile app that provides caregiver skills, with one group also receiving Mentalizing Imagery Therapy (MIT)—a method using mindfulness and guided imagery to reduce stress. The goal is to determine if the app with MIT is more effective than the app alone in lowering stress levels. Primary caregivers for someone with dementia who are 50 or older and regularly use a smartphone might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance caregiver support.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mentalizing Imagery Therapy (MIT) is generally well-received by caregivers of people with dementia. Studies on the MIT mobile app found it could lower stress and boost mood with few side effects. Caregivers found the app easy to use and helpful for support.

Research on the caregiver skills mobile app found it useful for managing caregiving tasks. Users felt more supported and less stressed. The app did not cause significant negative effects, making it a safe tool for caregivers.

Both apps appear safe for caregivers, offering stress relief and support without major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for dementia caregivers because they leverage technology to provide support and therapy in innovative ways. The caregiver skills mobile application offers practical tools and resources directly through a smartphone, making it easily accessible for caregivers who may struggle to attend in-person sessions. Mentalizing Imagery Therapy combines mental exercises with the app to help caregivers understand and manage their emotions, potentially reducing stress and improving caregiver well-being. These approaches are distinct from traditional support groups and counseling by integrating mental health support with everyday technology, offering flexibility and convenience.

What evidence suggests that this trial's treatments could be effective for reducing stress in dementia caregivers?

Research has shown that Mentalizing Imagery Therapy (MIT) combined with a caregiver skills app, one of the treatment arms in this trial, yields promising results. Studies have found that it improves caregivers' mental well-being by reducing symptoms like depression and anxiety. Users report feeling more balanced and better equipped to handle caregiving challenges.

In another treatment arm of this trial, participants will use the standalone caregiver skills app. Research suggests that mobile apps can effectively support dementia caregivers. These apps help reduce caregiving stress by providing information and tools for management. Both treatments in this trial aim to improve caregivers' mental health and ease their caregiving tasks. ^{1 2 6 7 8}

Who Is on the Research Team?

Felipe A Jain, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for family caregivers aged 60 or older who regularly use a smartphone and are the primary caregiver for a relative with dementia. They must speak English fluently. Those with recent suicide attempts, cognitive impairments, unstable medical conditions, substance abuse issues, active psychosis or mania, or frequent mindfulness practices are excluded.

Inclusion Criteria

You are the main person taking care of a family member with memory problems (as identified by yourself).

Fluent in the English language

I am 60 years old or older.

Exclusion Criteria

You have tried to harm yourself in the past 6 months or currently want to harm yourself.

You have practiced mindfulness or guided imagery more than once a week in the last three months.

You have had problems with drugs or alcohol in the past six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mentalizing Imagery Therapy and caregiver skills training via a mobile application

8 weeks

Remote app usage

Follow-up

Participants are monitored for psychological outcomes and app usage effects

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver skills mobile application
• Mentalizing Imagery Therapy and caregiver skills mobile application

Trial Overview The study tests if a mobile app delivering Caregiver skills (CS-App) combined with Mentalizing Imagery Therapy (MIT), which includes mindfulness and guided imagery exercises to reduce stress, is more effective than the CS-App alone in reducing caregivers' perceived stress over an 8-week period and at a 24-week follow-up.

How Is the Trial Designed?

Group I: Mentalizing Imagery Therapy and caregiver skills mobile application Experimental Treatment 1 Intervention

Group II: Caregiver skills mobile application Active Control 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11311318/

Effectiveness of Internet-Based or Mobile App Interventions ... This study evaluated the effectiveness of internet-based or mobile app interventions for family caregivers of older adults with dementia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9237854/

Mobile application use by family caregivers of persons living ... The purpose of the study was to explore the experiences of family caregivers of persons living with dementia on using apps in their caregiving roles.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07212894

DemensiaKITA Mobile Health App to Improve Knowledge, ... The results of this study will provide evidence on the effectiveness of a locally developed mobile health application in supporting dementia ...

4. aging.jmir.org aging.jmir.org/2024/1/e58517/

mHealth Apps for Dementia Caregivers - JMIR Aging Existing dementia care apps do not provide sufficient high-quality, tailored information for informal caregivers.

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1579239/pdf

A systematic review of the effectiveness of technological ... This finding supports the evidence that mobile and technological applications for caregivers are an effective solution to reduce their burden, ...

6. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.19332

Family Caregiver Support Apps: Questionable Evidence ... Research is needed to help family caregivers and area agencies on aging vet and identify apps that effectively support quality care of older ...

7. mdpi.com mdpi.com/2227-9032/12/15/1494

Effectiveness of Internet-Based or Mobile App Interventions ... This study evaluated the effectiveness of internet-based or mobile app interventions for family caregivers of older adults with dementia.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223452/

Perspectives and Experiences of Family Caregivers Using ... Supportive mobile apps are effective tools for family caregivers of persons with dementia to obtain online information and psychological support.