Back to resultsSTRIDE: Stress Reduction in Dementia Caregivers
Primary Purpose
Caregiver Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Minds Program (HMP)
Wellness App (WA)
Sponsored by
About this trial
This is an interventional treatment trial for Caregiver Stress
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Minds Program (HMP)
Wellness App (WA)
Arm 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.
Participants in the WA group will be asked to listen to the app content for 10 minutes per day for the entire 12 weeks.
Outcomes
Primary Outcome Measures
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.
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).
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.
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.
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?"
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?"
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?"
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%.
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?"
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.
Secondary Outcome Measures
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. Scores can be summed to create a global emotional distress score (0-42).
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form - 8 item
We will use the PROMIS sleep disturbance short form to assess caregivers' sleep. Each item is rated on a 5-point scale with the overall score ranging from 8 to 40. Higher scores indicate greater severity of sleep disturbance.
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.
Stress Thermometer
We will use a stress thermometer scale (0-10) to assess how caregivers rate their level of stress each week: "During the past week, how would you rate your stress on a scale from 0-10? (0 = not at all; 10 = extremely stressed)?"
Sleep Thermometer
We will use a sleep thermometer scale (0-10) to assess quality of sleep: "During the past week, how would you rate your quality of sleep on a scale from 0-10? (0 = extremely low quality; 10 = extremely high quality)?"
Mindfulness Thermometer
We will use a mindfulness thermometer scale (0-10) to assess how caregivers rate their level of mindfulness each week: "During the past week, how would you rate your mindfulness on a scale from 0-10? (0 = not at all; 10 = extremely mindful)?"
Emotional Distress Thermometer
We will use an emotional distress thermometer scale (0-10) to assess how caregivers rate their level of distress each week: "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)?"
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?"
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.
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). Higher scores indicate greater levels of each sub scale.
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); workplace productivity (5 items). Each item is measured on 1-4 point scale. Sub scales with 4 items are scored from 4-16; sub scales with 5 items are scored from 5-20. Higher scores indicate higher levels of each sub scale's construct.
Full Information
NCT ID
NCT05732038
First Posted
January 20, 2023
Last Updated
March 24, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05732038
Brief Title
STRIDE: Stress Reduction in Dementia Caregivers
Official Title
Using Mobile Technology to Reduce Stress in Caregivers of Persons With Dementia. A Scalable Solution to a Growing Problem.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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), sleep, 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, emotional distress and sleep dysfunction 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Minds Program (HMP)
Arm Type
Experimental
Arm 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.
Arm Title
Wellness App (WA)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Minds Program (HMP)
Intervention Description
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
Intervention Name(s)
Wellness App (WA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Recruitment
Description
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.
Time Frame
0 weeks
Title
Adherence to one of the two apps
Description
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).
Time Frame
12 weeks
Title
Credibility and Expectancy Questionnaire (CEQ)
Description
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.
Time Frame
0 weeks
Title
Client Satisfaction Questionnaire (CSQ-3)
Description
This will be used to assess caregivers' satisfaction with the intervention. Scores range from 3 to 12, with higher values indicating higher satisfaction.
Time Frame
12 weeks
Title
Perceptions of daily meditations/podcast
Description
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?"
Time Frame
12 weeks
Title
Perceptions of emails and text reminders
Description
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?"
Time Frame
12 weeks
Title
Perceptions of the overall study
Description
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?"
Time Frame
12 weeks
Title
Feasibility of weekly Research Electronic Data Capture (RedCAP) measures
Description
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%.
Time Frame
12 weeks
Title
Perceptions of prompts/contacts in low adherence situations
Description
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?"
Time Frame
12 weeks
Title
Feasibility of quantitative measures
Description
We will assess the feasibility of the quantitative measures sent to caregivers with the benchmark of no questionnaires missing fully in >=25% caregivers.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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. Scores can be summed to create a global emotional distress score (0-42).
Time Frame
0 weeks, 12 weeks, 20 weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form - 8 item
Description
We will use the PROMIS sleep disturbance short form to assess caregivers' sleep. Each item is rated on a 5-point scale with the overall score ranging from 8 to 40. Higher scores indicate greater severity of sleep disturbance.
Time Frame
0 weeks, 12 weeks, 20 weeks
Title
Applied Mindfulness Process Scale (AMPS)
Description
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.
Time Frame
0 weeks, 12 weeks, 20 weeks
Title
Stress Thermometer
Description
We will use a stress thermometer scale (0-10) to assess how caregivers rate their level of stress each week: "During the past week, how would you rate your stress on a scale from 0-10? (0 = not at all; 10 = extremely stressed)?"
Time Frame
0-12 weeks, 20 weeks
Title
Sleep Thermometer
Description
We will use a sleep thermometer scale (0-10) to assess quality of sleep: "During the past week, how would you rate your quality of sleep on a scale from 0-10? (0 = extremely low quality; 10 = extremely high quality)?"
Time Frame
0-12 weeks; 20 weeks
Title
Mindfulness Thermometer
Description
We will use a mindfulness thermometer scale (0-10) to assess how caregivers rate their level of mindfulness each week: "During the past week, how would you rate your mindfulness on a scale from 0-10? (0 = not at all; 10 = extremely mindful)?"
Time Frame
0-12 weeks, 20 weeks
Title
Emotional Distress Thermometer
Description
We will use an emotional distress thermometer scale (0-10) to assess how caregivers rate their level of distress each week: "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)?"
Time Frame
0-12 weeks, 20 weeks
Title
Modified Patient Global Impression of Change (MPGI)
Description
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?"
Time Frame
12 weeks
Title
Perceived Stress Scale 10 items (PSS-10)
Description
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.
Time Frame
0 weeks, 12 weeks, 20 weeks
Title
Healthy Minds Index
Description
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). Higher scores indicate greater levels of each sub scale.
Time Frame
0 weeks, 12 weeks, 20 weeks
Title
Caregiver Reaction Scale
Description
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); workplace productivity (5 items). Each item is measured on 1-4 point scale. Sub scales with 4 items are scored from 4-16; sub scales with 5 items are scored from 5-20. Higher scores indicate higher levels of each sub scale's construct.
Time Frame
0 weeks, 12 weeks, 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana-Maria Vranceanu, PhD
Phone
6176437996
Email
AVRANCEANU@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Huberty, PhD
Email
jenhubertyphd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Huberty, PhD
Organizational Affiliation
Mays Cancer Center at UT Health San Antonio MD Anderson
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana-Maria Vranceanu, PhD
12. IPD Sharing Statement
Learn more about this trial
STRIDE: Stress Reduction in Dementia Caregivers
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