STRIDE: Stress Reduction in Dementia Caregivers

NCT ID: NCT05732038

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-06-03

Brief Summary

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

Detailed 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.

Conditions

Caregiver Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Healthy Minds Program (HMP)

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.

Group Type: EXPERIMENTAL

Healthy Minds Program (HMP)

Intervention Type: BEHAVIORAL

Participants assigned to the HMP group will be asked to complete a minimum of 10 minutes per day of meditation for 12 weeks. For the first four weeks, participants will listen to prescribed meditations that will teach them the foundations of mindfulness. During weeks 5-12, participants will have full access to the HMP meditation library.

Wellness App (WA)

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 Type: EXPERIMENTAL

Wellness App (WA)

Intervention Type: BEHAVIORAL

Participants in the WA group will listen to a minimum of 10 minutes per day of a caregiver specific educational podcast (including topics such as "Caring for the Caregiver" or "Folate and Preventing Alzheimer's") delivered via a mobile app for the 12 weeks. The app contains one podcast per day for twelve weeks.

Interventions

Healthy Minds Program (HMP)

Participants assigned to the HMP group will be asked to complete a minimum of 10 minutes per day of meditation for 12 weeks. For the first four weeks, participants will listen to prescribed meditations that will teach them the foundations of mindfulness. During weeks 5-12, participants will have full access to the HMP meditation library.

Intervention Type: BEHAVIORAL

Wellness App (WA)

Participants in the WA group will listen to a minimum of 10 minutes per day of a caregiver specific educational podcast (including topics such as "Caring for the Caregiver" or "Folate and Preventing Alzheimer's") delivered via a mobile app for the 12 weeks. The app contains one podcast per day for twelve weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ana-Maria Vranceanu, PhD

Associate Professor/Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana-Maria Vranceanu, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Jennifer Huberty, PhD

Role: PRINCIPAL_INVESTIGATOR

Mays Cancer Center at UT Health San Antonio MD Anderson

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Woodworth EC, Briskin EA, Plys E, Macklin E, Tatar RG, Huberty J, Vranceanu AM. Mindfulness-Based App to Reduce Stress in Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Single-Blind Feasibility Proof-of-Concept Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 13;12:e50108. doi: 10.2196/50108.

Reference Type: DERIVED

PMID: 37831492 (View on PubMed)

Other Identifiers

2022P001601

Identifier Type: -

Identifier Source: org_study_id