AgingCare2NCT05309577
Self-Care for Dementia Caregivers
A study testing Behavioral Self-Monitoring + Motivational Interviewing in people with Aging and Mental Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The Self-care for Dementia Caregivers Study is a behavioral health intervention that uses digital monitoring tools and motivational health coaching to help caregivers of persons with dementia engage in a regular routine of sleep and activity. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Mental Disorder, Eating, Healthy
- What is being tested?
- Behavioral Self-Monitoring + Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 10 Mar 2025
- 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 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being ≥60 years
- having been diagnosed with Alzheimer's disease, vascular dementia, mixed Alzheimer's/vascular dementia, or frontotemporal dementia
- living with their caregiver
- being willing to wear the watch and participate in assessments and calls
- being a primary caregiver for an ADRD patient
- being ≥50 years
Show all 11Show fewer
- experiencing stress/strain related to caregiving
- the person being cared for has problems with sleep or keeping a consistent routine
- scoring ≥5 on the PHQ-9 (experiencing depression symptoms)
- living with their care recipient
- being willing to try the app and participate in assessments and calls
Who cannot join
- being less than 60 years
- not having a diagnosis of ADRD
- not living with their caregiver
- not being willing to wear the watch and participate in assessments and calls
- being less than 50 years
- not experiencing stress/strain related to caregiving
Show all 11Show fewer
- the person being cared for does not have problems with sleep or keeping a consistent routine
- scoring <5 on the PHQ-9
- not living with their care recipient
- not being willing to try the app and participate in assessments and calls
- Participants of this study may enroll as care givers or recipient-caregiver dyads.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Self-Care for Dementia Caregivers Using the myRhythmWatch
The Self-care for Dementia Caregivers Study is a behavioral health intervention that uses digital monitoring tools and motivational health coaching to help caregivers of persons with dementia engage in a regular routine of sleep and activity. Participants wear an apple watch for the objective collection of sleep-wake rhythms. They receive personalized feedback on their sleep-wake rhythms via a new app. Health coaches call participants weekly, for up to 6 weeks to help participants meet their health/sleep goals and promote self-knowledge of regular routines. Participants will help the study team improve the design elements and content of the mobile app. The goal of this intervention is to reduce depressive and insomnia symptoms.
Read the detailed description
Caregivers of family members with Alzheimer's Disease (AD) and AD-related dementias (ADRD) experience high rates of psychological stress, physical impairments, and often, disruptions in normal daily activities. Caregivers must be alert both at night and during the day, and often on an inconsistent schedule. As a result, caregivers are less likely to sleep, exercise, and be socially active on a regular schedule. Disruptions of these biological and behavioral time cues, or "zeitgebers", in turn decrease the stability of the body's biological clock, placing caregivers at high risk for adverse health outcomes related to an out-of-sync biological clock (e.g. diabetes, cardiovascular disease, and depression, among others). Caregivers of individuals with ADRD experience worse health outcomes compared with other types of caregivers, likely due to more heavily or frequently disrupted schedules.
For this research study, up to 25 individuals aged 50 and older who are providing care for a family member with mild-to-moderate dementia will be included. Data from 5 participants will be used for the development of an intervention manual (NIH Stage Model IA). A small pilot study will be conducted (NIH Stage Model IB) in which 20 participants will use a new mobile app - my rhythm watch - for up to 6 weeks. Objective actigraphic measures of the 24-hour pattern of sleep and daytime activity - known as the circadian rest-activity rhythm (RAR) - will be measured continuously via the apple watch to evaluate circadian rhythms as a potential intervention target/mechanism of action. The investigators will measure the regularity, timing, and amplitude of behavioral patterns over a 24-hour period. Participants will be assessed at baseline, post-intervention, and 3-months post-intervention. Initially our plan was to focus an intervention on promoting self-care and reducing caregiving burden. However, in designing the trial, we switched the focus to the circadian-informed, behavioral activation-based approach that aimed to improve sleep and mood in caregivers. Therefore, the two main outcomes of interest were measures of depression symptom severity and insomnia symptom severity.
The study as described in the original registration (April 2022) never proceeded. The registration has been revised to reflect the study as modified after securing a technology partner (per funding requirements) and prior to study initiation
- Conditions
- Aging, Mental Disorder, Eating, Healthy, Physical Inactivity, Prodromal Symptoms, Sleep
- Being tested
- Behavioral Self-Monitoring + Motivational Interviewing
- Keywords
- Caregivers, Carers, Alzheimer Disease, Alzheimer Dementia, Dementia, Twenty-Four Hour Rhythm, Geriatrics, Self Care, Circadian Rhythm
- Medical subject headings
- Mental Disorders, Sedentary Behavior, Prodromal Symptoms, Alzheimer Disease, Dementia, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Self-Monitoring + Motivational InterviewingBehavioural
Participants (n=20) will wear a iWatch to continuously measure their objective sleep-wake activity. The iWatch data sync to the new myRhythmWatch app, where participants will monitor their behavioral rhythm. Participants will also interact with a 'health coach' about their recorded behaviors weekly. This health coach will use motivational interviewing to enhance older adult caregivers' confidence and intrinsic motivation to engage in regular self-care.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver Intervention | Experimental | Behavioral self-monitoring of sleep and activity up to 6 weeks, using the myRhythmWatch app, and motivational health coaching. Receives: Behavioral: Behavioral Self-Monitoring + Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre/Post Change in Depressive Symptoms
The 9-item Patient Health Questionnaire (PHQ-9) scale is a self-reported questionnaire to be completed by the participant that assesses severity of depression. The PHQ-9 will be administered throughout the study to assess changes in depressive symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 27, indicating more severe impacts to patient health.
Measured: Up to 6 weeks
Pre/Post Change in Insomnia Symptoms
The 7-item Insomnia Severity Index (ISI) is a self-reported questionnaire to be completed by the participant that assesses severity of insomnia. The ISI will be administered throughout the study to assess changes in insomnia symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 28, indicating more severe impacts to patient health.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start7 Mar 2023
- Primary completion1 Dec 2024
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Activity Rhythm Solutions Corporation, Oregon Health and Science University
- Responsible party
- Principal investigator, Sarah T. Stahl, PhD, University of Pittsburgh
- Investigators
- Sarah T Stahl, PhD, Principal investigator, University of Pittsburgh, Assistant Professor of Psychiatry and Clinical and Translational Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309577
- Sponsor's protocol ID
- STUDY21060122
- Other IDs
- P30AG024978, R41AG069596
- Acronym
- Care2
- Status last verified
- Nov 2025
- First submitted
- 24 Mar 2022
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial will be available, after de-identification.
Publications
Stahl ST, Rodakowski J, Patira R, Smagula SF. Enhancing a Behavioral Intervention Using Rest-Activity Rhythm Monitoring via a Consumer Wearable in Older Dementia Caregivers and People With Dementia: Feasibility and Acceptability Study. JMIR Form Res. 2026 Sep 30;10:e88773. doi: 10.2196/88773.
PubMed 42815039
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Care for Dementia Caregivers Using the myRhythmWatch
- ClinicalTrials.gov ID
- NCT05309577
- Acronym / sponsor ID
- Care2 / STUDY21060122
- Conditions
- Aging, Mental Disorder, Eating, Healthy, Physical Inactivity, Prodromal Symptoms, Sleep
- Keywords
- Caregivers, Carers, Alzheimer Disease, Alzheimer Dementia, Dementia, Twenty-Four Hour Rhythm, Geriatrics, Self Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Activity Rhythm Solutions Corporation, Oregon Health and Science University
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 23 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Self-care for Dementia Caregivers Study is a behavioral health intervention that uses digital monitoring tools and motivational health coaching to help caregivers of persons with dementia engage in a regular routine of sleep and activity. Participants wear an apple watch for the objective collection of sleep-wake rhythms. They receive personalized feedback on their sleep-wake rhythms via a new app. Health coaches call participants weekly, for up to 6 weeks to help participants meet their health/sleep goals and promote self-knowledge of regular routines. Participants will help the study team improve the design elements and content of the mobile app. The goal of this intervention is to reduce depressive and insomnia symptoms.
Detailed description
Caregivers of family members with Alzheimer's Disease (AD) and AD-related dementias (ADRD) experience high rates of psychological stress, physical impairments, and often, disruptions in normal daily activities. Caregivers must be alert both at night and during the day, and often on an inconsistent schedule. As a result, caregivers are less likely to sleep, exercise, and be socially active on a regular schedule. Disruptions of these biological and behavioral time cues, or "zeitgebers", in turn decrease the stability of the body's biological clock, placing caregivers at high risk for adverse health outcomes related to an out-of-sync biological clock (e.g. diabetes, cardiovascular disease, and depression, among others). Caregivers of individuals with ADRD experience worse health outcomes compared with other types of caregivers, likely due to more heavily or frequently disrupted schedules.
For this research study, up to 25 individuals aged 50 and older who are providing care for a family member with mild-to-moderate dementia will be included. Data from 5 participants will be used for the development of an intervention manual (NIH Stage Model IA). A small pilot study will be conducted (NIH Stage Model IB) in which 20 participants will use a new mobile app - my rhythm watch - for up to 6 weeks. Objective actigraphic measures of the 24-hour pattern of sleep and daytime activity - known as the circadian rest-activity rhythm (RAR) - will be measured continuously via the apple watch to evaluate circadian rhythms as a potential intervention target/mechanism of action. The investigators will measure the regularity, timing, and amplitude of behavioral patterns over a 24-hour period. Participants will be assessed at baseline, post-intervention, and 3-months post-intervention. Initially our plan was to focus an intervention on promoting self-care and reducing caregiving burden. However, in designing the trial, we switched the focus to the circadian-informed, behavioral activation-based approach that aimed to improve sleep and mood in caregivers. Therefore, the two main outcomes of interest were measures of depression symptom severity and insomnia symptom severity.
The study as described in the original registration (April 2022) never proceeded. The registration has been revised to reflect the study as modified after securing a technology partner (per funding requirements) and prior to study initiation
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver Intervention | Experimental | Behavioral: Behavioral Self-Monitoring + Motivational InterviewingBehavioral self-monitoring of sleep and activity up to 6 weeks, using the myRhythmWatch app, and motivational health coaching. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- being ≥60 years
- having been diagnosed with Alzheimer's disease, vascular dementia, mixed Alzheimer's/vascular dementia, or frontotemporal dementia
- living with their caregiver
- being willing to wear the watch and participate in assessments and calls
- being a primary caregiver for an ADRD patient
Key exclusion criteria (11 listed)
- being less than 60 years
- not having a diagnosis of ADRD
- not living with their caregiver
- not being willing to wear the watch and participate in assessments and calls
- being less than 50 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Self-Monitoring + Motivational InterviewingParticipants (n=20) will wear a iWatch to continuously measure their objective sleep-wake activity. The iWatch data sync to the new myRhythmWatch app, where participants will monitor their behavioral rhythm. Participants will also interact with a 'health coach' about their recorded behaviors weekly. This health coach will use motivational interviewing to enhance older adult caregivers' confidence and intrinsic motivation to engage in regular self-care. | Behavioural | Caregiver Intervention |
Primary outcome
Pre/Post Change in Depressive Symptoms
Time frame: Up to 6 weeks
The 9-item Patient Health Questionnaire (PHQ-9) scale is a self-reported questionnaire to be completed by the participant that assesses severity of depression. The PHQ-9 will be administered throughout the study to assess changes in depressive symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 27, indicating more severe impacts to patient health.
Pre/Post Change in Insomnia Symptoms
Time frame: Up to 6 weeks
The 7-item Insomnia Severity Index (ISI) is a self-reported questionnaire to be completed by the participant that assesses severity of insomnia. The ISI will be administered throughout the study to assess changes in insomnia symptoms pre- and post-intervention. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 28, indicating more severe impacts to patient health.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42815039Stahl ST, Rodakowski J, Patira R, Smagula SF. Enhancing a Behavioral Intervention Using Rest-Activity Rhythm Monitoring via a Consumer Wearable in Older Dementia Caregivers and People With Dementia: Feasibility and Acceptability Study. JMIR Form Res. 2026 Sep 30;10:e88773. doi: 10.2196/88773.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial will be available, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah T Stahl, PhD principal investigator
University of Pittsburgh, Assistant Professor of Psychiatry and Clinical and Translational Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Self-Monitoring + Motivational Interviewing in people with Aging and Mental Disorder, run by University of Pittsburgh 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 11 inclusion and 11 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 23 Jan 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 23 Jan 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?
Pre/Post Change in Depressive Symptoms (time frame: Up to 6 weeks). The study lists 2 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 NCT05309577, which also lists 1 linked publication.
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 23 Jan 2026; AzTrials last refreshed its copy on 29 Oct 2026.