What side effects are associated with this type of intervention?

Mindfulness and guided imagery therapies, similar to Mentalizing Imagery Therapy (MIT), are generally considered safe with minimal side effects. Commonly reported side effects include temporary increases in anxiety or emotional discomfort as individuals confront stressors or emotions during sessions. Some individuals may also experience mild fatigue or drowsiness. However, these side effects are typically short-lived and resolve as individuals become more accustomed to the practices.

What prior FDA approvals exist?

There are no specific FDA approvals for treatments exclusively targeting family caregivers. However, treatments that include mindfulness and guided imagery, similar to Mentalizing Imagery Therapy (MIT), are generally used for stress reduction and mental health support. FDA-approved medications for stress and anxiety, such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines, can be prescribed to caregivers experiencing significant stress. Additionally, non-pharmacological interventions like cognitive-behavioral therapy (CBT) and other mindfulness-based stress reduction (MBSR) programs are widely recognized and utilized, although they do not require FDA approval.

What other types of research exist?

Promising alternatives to MIT for family caregivers include Mindfulness-Based Cognitive Therapy (MBCT), which focuses on present moment experience and metacognitive awareness, and Mindfulness-Based Stress Reduction (MBSR), which has shown broad symptom improvement in various patient populations. Additionally, mobile app-based psychological interventions that provide mindfulness and stress reduction tools could be a convenient and effective option for caregivers with time constraints.

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Mobile App Psychological Interventions for Dementia Caregivers

N/A

Waitlist Available

Led By Felipe A Jain, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Age ≥ 60 years

Be older than 18 years old

Must not have

Unstable medical illness or planned major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a smartphone app delivering Mentalizing Imagery Therapy (MIT) to help family caregivers of dementia patients reduce stress. The therapy uses mindfulness and guided imagery to improve understanding of oneself and others. It aims to make stress reduction more accessible for caregivers who can't attend in-person sessions. Mentalizing Imagery Therapy (MIT) has been studied for its potential to reduce stress and improve well-being among family caregivers of dementia patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves psychological interventions through an app rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort when engaging in self-reflection exercises within MIT.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any unstable illnesses or upcoming major surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perceived Stress Scale (PSS)

Secondary study objectives

Caregiver Mastery Index (CMI)

Insomnia Severity Index (ISI)

Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mentalizing Imagery Therapy and caregiver skills mobile applicationExperimental Treatment1 Intervention

Group II: Caregiver skills mobile applicationActive Control1 Intervention

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mentalizing Imagery Therapy (MIT) combines mindfulness and guided imagery to help family caregivers manage stress and improve their mental health. Mindfulness involves focusing attention on the present moment without judgment, which can reduce stress and enhance emotional regulation. Guided imagery uses visualization techniques to create calming mental images, promoting relaxation and reducing anxiety. These mechanisms are crucial for family caregivers as they often experience chronic stress and emotional burden due to their caregiving responsibilities. By improving stress management and emotional well-being, MIT can enhance caregivers' overall quality of life and their ability to provide care.