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Stress Reduction Apps for Dementia Caregiver Stress
N/A
Waitlist Available
Led By Ana-Maria Vranceanu, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-12 weeks, 20 weeks
Awards & highlights
Study Summary
This trial will test if a smartphone app intervention can reduce stress, depression and anxiety, improve sleep, and increase mindfulness in caregivers of those with Alzheimer's disease.
Who is the study for?
This trial is for stressed caregivers aged 18 or older who speak English and provide unpaid care to someone with Alzheimer's or related dementias. Caregivers must feel stressed, as measured by a specific stress scale, and be open to random assignment in the study. Their care recipients should also have certain functional impairments.Check my eligibility
What is being tested?
The STRIDE trial is testing two smartphone apps: Healthy Minds Program (HMP) versus Wellness App (WA). It aims to see if these apps can reduce caregiver stress, emotional distress, improve sleep quality, and increase mindfulness among caregivers of dementia patients.See study design
What are the potential side effects?
Since this trial involves non-pharmacological interventions like smartphone apps for meditation and wellness activities, there are no direct medical side effects expected from participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-12 weeks, 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 weeks, 20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to one of the two apps
Client Satisfaction Questionnaire (CSQ-3)
Credibility and Expectancy Questionnaire (CEQ)
+7 moreSecondary outcome measures
Applied Mindfulness Process Scale (AMPS)
Caregiver Reaction Scale
Emotional Distress Thermometer
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Wellness App (WA)Experimental Treatment1 Intervention
Participants in the WA group will be asked to listen to the app content for 10 minutes per day for the entire 12 weeks.
Group II: Healthy Minds Program (HMP)Experimental Treatment1 Intervention
Participants assigned to the HMP group will be asked to practice 10 minutes per day for 12 weeks. The first four weeks will be prescribed. Weeks 5-12 will allow full access to the app's library.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,937 Previous Clinical Trials
13,198,957 Total Patients Enrolled
2 Trials studying Caregiver Stress
178 Patients Enrolled for Caregiver Stress
Ana-Maria Vranceanu, PhDPrincipal InvestigatorMassachusetts General Hospital
20 Previous Clinical Trials
1,993 Total Patients Enrolled
1 Trials studying Caregiver Stress
80 Patients Enrolled for Caregiver Stress
Jennifer Huberty, PhDPrincipal InvestigatorMays Cancer Center at UT Health San Antonio MD Anderson
8 Previous Clinical Trials
1,285 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not expect my health to significantly worsen or need surgery in the next 20 weeks.I am currently receiving treatment for cancer.I am currently participating in a meditation program.My care recipient will be placed in a nursing home or with another caregiver soon.I have used a meditation app for over an hour a month in the last 6 months.I am 65 or older and made four or more mistakes on a mental health quiz.I am 18 years old or older.I will not change my mental health medications during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Minds Program (HMP)
- Group 2: Wellness App (WA)
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.
Is enrollment to this investigation still open for participants?
"It is stated on clinicaltrials.gov that the trial has ceased patient recruitment; it was initially posted on February 20th, 2023 and last updated on February 8th, 2023. However, 398 other studies are actively looking for patients at this time."
Answered by AI
What are the fundamental goals of this research endeavor?
"This trial, which will take place over the span of 0 weeks, aims to measure adherence to one of two applications. Secondary outcomes include an assessment of sleep disturbance using PROMIS' Sleep Disturbance Short Form - 8 item (scores range from 8-40 with higher numbers indicating greater severity), Applied Mindfulness Process Scale's de-centering, positive emotion regulation and negative emotion regulation sub scales (overall scores ranging from 0-60 where higher values indicate more mindfulness), and a stress thermometer scale which goes from 0-10 (0 corresponds to no stress while 10 is extremely stressed)."
Answered by AI
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