STRIDE: Stress Reduction in Dementia Caregivers

Mass General Brigham

Status: Completed

Conditions: Caregiver Stress

Treatments: Behavioral: Healthy Minds Program (HMP); Behavioral: Wellness App (WA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05732038

2022P001601

Details and patient eligibility

About

The investigators aim to conduct a feasibility, proof of concept randomized controlled trial (RCT) of a smartphone app intervention (Healthy Minds Program; HMP) versus Wellness app (WA) among heterogeneous stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). The investigators will test its feasibility (primary outcomes) and its preliminary effect in improvement in caregiver stress, emotional distress (depression and anxiety), and mindfulness. Participants will be randomized to one of the two conditions described above

Full description

Using the NIA 2 year R21 grant mechanisms, we will examine the feasibility (markers of acceptability and demand), and proof of concept of Healthy Minds Program (HMP) versus Wellness App (WA) in decreasing stress and emotional distress in heterogeneous, geographically diverse, stressed caregivers of individuals with Alzheimer's disease and related dementias (ADRD). Participants in each arm will be asked to practice for 10 min/day.

To achieve our aims, we will conduct a single blind, pilot, feasibility, proof of concept randomized controlled trial (RCT) of HMP (12 weeks, > 10 minutes daily) versus WA; 12 weeks, >10 minutes daily). Assessments will be conducted at baseline, post program (12 weeks later) and at 20 weeks follow-up (~2 months after post-test). Caregivers will also complete weekly assessments.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years or older
2. English fluency and literacy
3. Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care)
4. Perceived Stress Scale (4 items) version >= 6
5. Willing to be randomized
6. Care recipient must score >1 on the functional assessment scale (FAST)

Exclusion criteria

1. Any planned change in psychotropic pharmacologic treatment for the duration of the study
2. Use of any consumer-based mindfulness meditation app for more than 60 min/month in the past 6 months.
3. Current participation in a meditation program (e.g., mindfulness-based stress reduction, mindfulness-base cognitive therapy, etc.)
4. Major illness known to worsen dramatically or require surgery in the next 20 weeks (study duration)
5. Active treatment for cancer (chemotherapy, radiation)
6. Imminent placement of care recipient in a nursing home or with another caregiver (within 4 months).
7. Involvement in another clinical trial for caregivers.
8. For participants age 65 and older: four or more errors on the Short Portable Mental Status questionnaire (SPMSQ)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Healthy Minds Program (HMP)

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy Minds Program (HMP)

Wellness App (WA)

Experimental group

Description:

Participants in the WA group will be asked to listen to the app content for 10 minutes per day for the entire 12 weeks.

Treatment:

Behavioral: Wellness App (WA)