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Mobile App Psychological Interventions for Dementia Caregivers
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-weeks
Awards & highlights
Study Summary
This trial seeks to determine if using a smartphone app to provide stress relief to family caregivers of persons with dementia will improve their mental and physical health.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perceived Stress Scale (PSS)
Secondary outcome measures
Caregiver Mastery Index (CMI)
Insomnia Severity Index (ISI)
Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR)
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,381 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,543 Total Patients Enrolled
Felipe A Jain, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are the main person taking care of a family member with memory problems (as identified by yourself).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.You have trouble thinking clearly and remembering things.I do not have any unstable illnesses or upcoming major surgeries.You are currently experiencing severe mental illness with symptoms like hallucinations or extreme excitement.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Mentalizing Imagery Therapy and caregiver skills mobile application
- Group 2: Caregiver skills mobile application
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open spaces for participants in this investigation?
"Clinicaltrials.gov attests that this medical trial is actively searching for participants, having first been posted on May 1st 2023 and last edited April 12th of the same year."
Answered by AI
To what extent is this trial being populated by research subjects?
"Affirmative. Clinicaltrials.gov specifies that this research project, which was made public on the first of May 2023, is currently enrolling participants. The proposed study aims to recruit 120 individuals from a single site."
Answered by AI
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