STRIDE: Stress Reduction in Dementia Caregivers

NCT05732038 | Completed DMC

• 1 other identifier: 2022P001601
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Caregiver Stress

Outcome Measures

Primary Outcomes (10)

• 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.

  0 weeks

• 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 \>=70% of caregivers will complete \>=75% of weekly prescribed minutes (\>=10 minutes/day).

  12 weeks

• Credibility and Expectancy Questionnaire (CEQ)

  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.

  0 weeks

• Client Satisfaction Questionnaire (CSQ-3)

  This will be used to assess caregivers' satisfaction with the intervention. Scores range from 3 to 12, with higher values indicating higher satisfaction.

  12 weeks

• 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?"

  12 weeks

• 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?"

  12 weeks

• 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?"

  12 weeks

• Feasibility of weekly 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%.

  12 weeks

• 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?"

  12 weeks

• 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.

  20 weeks

Secondary Outcomes (9)

• Hospital Anxiety and Depression Scale (HADS)

  0 weeks, 12 weeks, 20 weeks

• Applied Mindfulness Process Scale (AMPS)

  0 weeks, 12 weeks, 20 weeks

• Stress Thermometer

  0-12 weeks, 20 weeks

• Mindfulness Thermometer

  0-12 weeks, 20 weeks

• Emotional Distress Thermometer

  0-12 weeks, 20 weeks

Study Arms (2)

Healthy Minds Program (HMP)

EXPERIMENTAL

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.

Behavioral: Healthy Minds Program (HMP)

Wellness App (WA)

EXPERIMENTAL

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

Behavioral: Wellness App (WA)

Interventions

Healthy Minds Program (HMP) 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.

Healthy Minds Program (HMP)

Wellness App (WA) 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.

Wellness App (WA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 37831492 DERIVED

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jennifer Huberty, PhD

  Mays Cancer Center at UT Health San Antonio MD Anderson

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Director

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 16, 2023
• Study Start: February 20, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: October 21, 2025

Record last verified: 2024-01

Locations

US (1)