AzTrials
AzTrials

Caregiver StressNCT05732038

STRIDE: Stress Reduction in Dementia Caregivers

A study testing Healthy Minds Program (HMP) and Wellness App (WA) in people with Caregiver Stress, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Caregiver Stress
What is being tested?
Healthy Minds Program (HMP) and Wellness App (WA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteUnited States
Study dates
20 Feb 2023to 3 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Using Mobile Technology to Reduce Stress in Caregivers of Persons With Dementia. A Scalable Solution to a Growing Problem.

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

Read the 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.

Being tested
Healthy Minds Program (HMP), Wellness App (WA)
Medical subject headings
Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Minds Program (HMP)Behavioural

    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)Behavioural

    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.

Study groups in NCT05732038
Study groupRoleWhat they receive
Healthy Minds Program (HMP)ExperimentalParticipants 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.
Receives: Behavioral: Healthy Minds Program (HMP)
Wellness App (WA)ExperimentalParticipants in the WA group will be asked to listen to the app content for 10 minutes per day for the entire 12 weeks.
Receives: Behavioral: Wellness App (WA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Recruitment

    We will assess number of dementia caregivers enrolled from the number of caregivers that were eligible. Our primary aim focuses on feasibility of recruitment during the trial.

    Measured: 0 weeks

  2. Number of Participants With Adherence to One of the Two Apps

    We will assess data from the Healthy Minds Program app and the Podcast app to measure adherence to the intervention and the control conditions. Our benchmark will be that caregivers will complete >=75% of weekly prescribed minutes (>=10 minutes/day).

    Measured: 12 weeks

  3. Number of Participants With Credibility and Expectancy Questionnaire (CEQ) Scores Above the Midpoint (>15)

    We will use the Credibility and Expectancy Questionnaire (CEQ) to assesses caregivers perceptions that the treatment will work after learning about the study. Scores range from 3-27; higher ratings indicate more belief that the program is logical and will help with the intended outcome. Composite scores were derived. Scores indicate number of participants who had scores above the midpoint (>15) for credibility and expectancy.

    Measured: 0 weeks

  4. Number of Participants Client Satisfaction Questionnaire (CSQ-3) Score >7.5

    This will be used to assess caregivers' satisfaction with the intervention. Scores range from 3 to 12, with higher values indicating higher satisfaction. Credibility was determined by a score of 7.5 or greater. The number of participants in each group with a score of 7.5 or greater is reported.

    Measured: 12 weeks

  5. Perceptions of Daily Meditations/Podcast

    We will assess caregivers' perception of their app's prescription by asking, "Do you think that the amount of daily prescribed app content was: too little, just enough, or too much?"

    Measured: 12 weeks

  6. Perceptions of Emails and Text Reminders

    We will assess caregivers' perception of emails and text message reminders by asking, "Do you think that the amount of emails/texts you received was: too little, just enough, too much?"

    Measured: 12 weeks

  7. Perceptions of the Overall Study

    We will assess caregivers' perceptions of the study by asking, "Do you have any feedback about your experience in this program (content of the program, content of the text message reminders, etc.) that you would like to share?"

    Measured: 12 weeks

  8. Number of Caregivers Who Responded to >=75% Research Electronic Data Capture (RedCAP) Measures

    We will assess the feasibility of the weekly REDCap measures sent to patients by review of responses to ensure that >=70% caregivers will answer >=75%. Reported below is the number of caregivers who responded to >=75% of the REDCap measures.

    Measured: 12 weeks

  9. Perceptions of Prompts/Contacts in Low Adherence Situations

    We will assess caregivers' perception of the amount of prompts and contact in situations where they were not adhering to their practice by asking "Do you think that the amount of prompts you received when you struggled with your practice was: too little, just enough, too much?"

    Measured: 12 weeks

  10. Number of Participants With no Quantitative Measures Fully Missing (Feasibility of Quantitative Measures)

    We will assess the feasibility of the quantitative measures sent to caregivers with the benchmark of no questionnaires missing fully in >=25% caregivers.

    Measured: 20 weeks

Secondary outcomes (9)

  1. Hospital Anxiety and Depression Scale (HADS)

    We will use the Hospital Anxiety and Depression Scale HADS, a 14-item measure that assesses symptoms of emotional distress (anxiety and depression). The anxiety and depression sub-scale are each scored from 0-21, with higher scores indicating greater severity of symptoms.

    Measured: 0 weeks, 12 weeks, 20 weeks

  2. Applied Mindfulness Process Scale (AMPS)

    We will use the Applied Mindfulness Process Scale (AMPS) to assess caregivers mindfulness. AMPS consists of 3 sub scales: de-centering, positive emotion regulation, and negative emotion regulation. Each sub scale is scored from 0-20. An overall score ranging from 0-60 can be obtained by summing all 15 items. Higher scores indicate greater mindfulness.

    Measured: 0 weeks, 12 weeks, 20 weeks

  3. Stress Thermometer

    We will use a stress thermometer scale (0-10) to assess how caregivers rate their level of stress: "During the past week, how would you rate your stress on a scale from 0-10? (0 = not at all; 10 = extremely stressed)?"

    Measured: 0 weeks, 12 weeks, 20 weeks

  4. Mindfulness Thermometer

    We will use a mindfulness thermometer scale (0-10) to assess how caregivers (in the HMP group) rate their level of mindfulness: "During the past week, how would you rate your mindfulness on a scale from 0-10? (0 = not at all; 10 = extremely mindful)?"

    Measured: 12 weeks, 20 weeks

  5. Emotional Distress Thermometer

    We will use an emotional distress thermometer scale (0-10) to assess how caregivers rate their level of distress: "During the past week, how would you rate your emotional distress on a scale from 0-10? (0 = not at all; 10 = extremely emotionally distressed)?"

    Measured: 0 weeks, 12 weeks, 20 weeks

  6. Modified Patient Global Impression of Change (MPGI)

    We will use the Modified Patient Global Impression of Change (MPGI), a 1-item questionnaire, to assess the extent to which caregivers perceive the intervention improved functioning and symptoms: "Do you think your ability to manage stress associated with caring for your loved one with dementia is now improved, about the same, or worse, as compared to before your participation in this program?"

    Measured: 12 weeks

  7. Perceived Stress Scale 10 Items (PSS-10)

    We will use the PSS-10, to assess perceived stress using a 5-point Likert scale. Scores range from 0 to 40 with higher scores indicating greater stress.

    Measured: 0 weeks, 12 weeks, 20 weeks

  8. Healthy Minds Index

    This is a 17-item measure (each item is scored on a 0-4 scale) that assesses awareness (items 1-4; scored from 0-16), connection (items 5-10; scored from 0-24), insight (items 11-13; scored from 0-12), and purpose (items 14-17; scored from 0-16). Total score is calculated by summing subscales. Higher scores indicate greater well-being on awareness, connection, insight, and purpose.

    Measured: 0 weeks, 12 weeks, 20 weeks

  9. Caregiver Reaction Scale

    This measure assesses caregiver burden. We are administering the following sub scales: role entrapment (4 items); role overload (4 items); mastery as a caregiver (4 items); self mastery (4 items). Each item is measured on 1-4 point scale. Sub scales with 4 items are scored from 4-16. Higher scores indicate higher levels of each sub scale's construct (i.e., entrapment, overload, and self/caregiver mastery).

    Measured: 0 weeks, 12 weeks, 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start20 Feb 2023
  3. Primary completion3 Jun 2024
  4. Study completion3 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05732038
Sponsor's protocol ID
2022P001601
Other IDs
1R01AG075899-01
Status last verified
May 2026
First submitted
20 Jan 2023
Last updated
30 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Plys E, Seward M, Allen EM, Tatar RG, Huberty J, Vranceanu AM. Pilot Randomized Controlled Trial of the Feasibility of a Mobile App-Delivered Mindfulness-Based Intervention for Caregiver Stress. Gerontologist. 2025 May 10;65(6):gnaf047. doi: 10.1093/geront/gnaf047.

    PubMed 39921878

  • 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.

    PubMed 37831492

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Minds Program (HMP) and Wellness App (WA) in people with Caregiver Stress, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment (time frame: 0 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05732038, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in