Clinical trial NCT05732038: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caregiver Stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: 0 weeks
measure: Adherence to one of the two apps
timeFrame: 12 weeks
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: 0 weeks
measure: Client Satisfaction Questionnaire (CSQ-3)
timeFrame: 12 weeks
measure: Perceptions of daily meditations/podcast
timeFrame: 12 weeks
measure: Perceptions of emails and text reminders
timeFrame: 12 weeks
measure: Perceptions of the overall study
timeFrame: 12 weeks
measure: Feasibility of weekly Research Electronic Data Capture (RedCAP) measures
timeFrame: 12 weeks
measure: Perceptions of prompts/contacts in low adherence situations
timeFrame: 12 weeks
measure: Feasibility of quantitative measures
timeFrame: 20 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 0 weeks, 12 weeks, 20 weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form - 8 item
timeFrame: 0 weeks, 12 weeks, 20 weeks
measure: Applied Mindfulness Process Scale (AMPS)
timeFrame: 0 weeks, 12 weeks, 20 weeks
measure: Stress Thermometer
timeFrame: 0-12 weeks, 20 weeks
measure: Sleep Thermometer
timeFrame: 0-12 weeks; 20 weeks
measure: Mindfulness Thermometer
timeFrame: 0-12 weeks, 20 weeks
measure: Emotional Distress Thermometer
timeFrame: 0-12 weeks, 20 weeks
measure: Modified Patient Global Impression of Change (MPGI)
timeFrame: 12 weeks
measure: Perceived Stress Scale 10 items (PSS-10)
timeFrame: 0 weeks, 12 weeks, 20 weeks
measure: Healthy Minds Index
timeFrame: 0 weeks, 12 weeks, 20 weeks
measure: Caregiver Reaction Scale
timeFrame: 0 weeks, 12 weeks, 20 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mays Cancer Center at UT Health San Antonio MD Anderson
name: Jennifer Huberty, PhD
role: PRINCIPAL_INVESTIGATOR
References: