Caregiver BurnoutNCT04150055
mHealth Mindfulness for Dementia Caregivers
A study testing Mindfulness Coach in people with Caregiver Burnout and Stress, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
The investigators will recruit 60 family caregivers of older adults with cognitive impairment or dementia to participate in a pilot feasibility and acceptability trial of Mindfulness Coach, an mHealth mobile application that delivers mindfulness therapy. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burnout, Stress, Anxiety
- What is being tested?
- Mindfulness Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Nov 2019to 8 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- owns a smart phone or tablet
- speaks English fluently, aged 21+
- identifies as the caregiver for an older adult with dementia or mild cognitive impairment
Who cannot join
- does not own smart phone or tablet
- does not speak English fluently
- is under age 21
- does not provide care for older adult with dementia or mild cognitive impairment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
RWJ Barnabas Monmouth South
Lakewood, New Jersey, 08701
RWJ Barnabas
Monroe, New Jersey, 08331
About this study
Official title: Piloting an mHealth Mindfulness Therapy Intervention to Alleviate Symptoms of Stress for Caregivers of Older Adults With Cognitive Impairment.
The investigators will recruit 60 family caregivers of older adults with cognitive impairment or dementia to participate in a pilot feasibility and acceptability trial of Mindfulness Coach, an mHealth mobile application that delivers mindfulness therapy. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The app also offers a library of information about MT (e.g., "how to anchor participants' attention"), 12 audio-guided mindfulness exercises, and a catalog of additional exercises available for free. In addition to collecting data about the feasibility and acceptability of Mindfulness Coach with caregivers of patients with dementia or cognitive impairment, the investigators will also collect data on preliminary efficacy of Mindfulness Coach at relieving symptoms of caregiver burden, anxiety, stress and depression.
Read the detailed description
The objective of this project is to evaluate the feasibility, acceptability and preliminary efficacy of Mindfulness Coach for stress and caregiver burden in caregivers of persons with dementia. The investigators will recruit participants across three outpatient geriatric primary care sites in the RWJ Barnabas Healthcare system: Monmouth, Monroe and New Brunswick.
Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The app also offers a library of information about MT (e.g., "how to anchor your attention"), 12 audio-guided mindfulness exercises, and a catalog of additional exercises available for free. The app tracks progress over time with a mindfulness mastery assessment, has customizable reminders which the patient will learn to set during orientation, and goal-setting and tracking features, which the patient will learn to customize during orientation. Mindfulness Coach was designed by a multidisciplinary team of experts in telehealth, technology and mental health from the VA's National Center for PTSD and the Department of Defense's National Center for Telehealth and Technology and is free and available on iOS and Android. In this study, the intervention will be introduced during 1 in-person session by a trained research assistant with 1-2 booster instructional phone call at 7 and 14-days to ensure that the participant knows how and is encouraged to use the app. The participant will also be provided with a laminated card that provides the basic instructions. The investigators will encourage the participant to use Mindfulness Coach weekly for 8 weeks, or more if desired, as this treatment dose is commensurate with most in-person MT psychotherapy treatment protocols.
Subjects and Sample Size:The investigators will recruit 60 patients from three RWJ Barnabas sites: Monmouth, Monroe and New Brunswick. Caregivers will be recruited by physician referral. Physicians will identify patients with a diagnosis of dementia or cognitive impairment and their family caregivers. The term "family caregiver" refers to any family member or relative who is involved in a patient's health care because of a personal connection, not for financial compensation. Family caregivers are eligible if they are age 21 or older, English-speaking, currently own a mobile device (smartphone or tablet) and spend at least 10 hours per week providing care to the older adult patient. Procedures: Providers will notify study coordinator of patients who have a diagnosis of dementia or cognitive impairment and typically have a family caregiver present during medical visits. Emails will be sent to providers to inquire about potential subjects. The study research assistant (RA) will call potential subjects to obtain consent for a phone screen. The screen will include questions about current caregiving practices and questions about mobile device usage (e.g., do participants own a smart phone or tablet? How often do participants use this device?). If a patient is eligible and interested in participating, an in-person baseline assessment and orientation will be scheduled at the primary care provider's office. Informed consent will be obtained in person prior to the baseline assessment. The baseline assessor will also be the individual who orients participants to Mindfulness Coach. Follow-up interviews will be conducted via telephone.
The orientation will consist of the following components: 1.) education about the app, its developers and MT (to establish credibility); 2.) discussion of goals of the app; 3.) procedural information about how to launch and navigate the app; and 4.) assessment of participant's ability to use the app: participants must be able to meet pre-established criteria of being able to open, launch, navigate and use the app independently prior to the end of the orientation session. During orientation, study personnel will discuss the benefits of daily, brief (5-15 minutes) mindfulness practice and ask participants if daily practice is a goal they would be willing to set. If the participant is amenable, study personnel will help participants set reminders (push notifications) within Mindfulness Coach to facilitate daily practice. The investigators will work with each participant to set mindfulness practice goals that are tailored to the unique needs of each participant. Participants will also be given a laminated instructional card explaining how to access and use Mindfulness Coach. Booster sessions: The study RA will schedule a 1-week booster phone call with intervention participants to troubleshoot potential difficulties users may be experiencing with the application. At this session, participants will be asked if they have used the app in their first week. If they have not, the investigators will schedule an additional follow up booster session phone call at 2-weeks to provide additional troubleshooting and encouragement.
- Conditions
- Caregiver Burnout, Stress, Anxiety
- Being tested
- Mindfulness Coach
- Keywords
- mindfulness, caregiver, palliative care
- Medical subject headings
- Caregiver Burden, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness CoachBehavioural
Mindfulness Coach is an mHealth delivered mindfulness therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Everyone in the study will get Mindfulness Coach and an orientation session. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The intervention will be introduced during 1 in-person session by a trained research assistant with 1-2 booster instructional phone call at 7 and 14-days to ensure that the participant knows how and is encouraged to use the app. The participant will also be provided with a laminated card that provides the basic instructions. We will encourage the participant to use Mindfulness Coach weekly for 8 weeks, or more if desired, as this treatment dose is commensurate with most in-person MT psychotherapy treatment protocols. Receives: Behavioral: Mindfulness Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - amount of time participants spend in app
how much do caregivers use mindfulness coach
Measured: 8 weeks
Acceptability - satisfaction with mindfulness coach survey
Do caregivers find mindfulness coach helpful and easy to use?
Measured: 8 weeks
Bakas Caregiver Outcomes Scale - 15 items
scores range from 15-105 with higher scores indicating better outcomes
Measured: 8 weeks
Secondary outcomes (4)
hospital anxiety and depression scale- anxiety sub scale
scores range from 0-21 with higher scores indicating worse outcomes
Measured: 8 weeks
hospital anxiety and depression scale, depression sub scale
scores range from 0-21 with higher scores indicating worse outcomes
Measured: 8 weeks
The World Health Organization Quality of Life Brief
scores range from 26-130 with higher scores indicating better outcomes
Measured: 8 weeks
perceived stress scale
scores range from 0-40 with higher scores indicating worse stress
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start5 Nov 2019
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elissa Kozlov, Ph.D, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150055
- Sponsor's protocol ID
- Pro2019001438
- Other IDs
- KL2TR003018
- Status last verified
- Sep 2021
- First submitted
- 30 Oct 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an mHealth Mindfulness Therapy Intervention to Alleviate Symptoms of Stress for Caregivers of Older Adults With Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT04150055
- Acronym / sponsor ID
- Pro2019001438
- Conditions
- Caregiver Burnout, Stress, Anxiety
- Keywords
- mindfulness, caregiver, palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will recruit 60 family caregivers of older adults with cognitive impairment or dementia to participate in a pilot feasibility and acceptability trial of Mindfulness Coach, an mHealth mobile application that delivers mindfulness therapy. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The app also offers a library of information about MT (e.g., "how to anchor participants' attention"), 12 audio-guided mindfulness exercises, and a catalog of additional exercises available for free. In addition to collecting data about the feasibility and acceptability of Mindfulness Coach with caregivers of patients with dementia or cognitive impairment, the investigators will also collect data on preliminary efficacy of Mindfulness Coach at relieving symptoms of caregiver burden, anxiety, stress and depression.
Detailed description
The objective of this project is to evaluate the feasibility, acceptability and preliminary efficacy of Mindfulness Coach for stress and caregiver burden in caregivers of persons with dementia. The investigators will recruit participants across three outpatient geriatric primary care sites in the RWJ Barnabas Healthcare system: Monmouth, Monroe and New Brunswick.
Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The app also offers a library of information about MT (e.g., "how to anchor your attention"), 12 audio-guided mindfulness exercises, and a catalog of additional exercises available for free. The app tracks progress over time with a mindfulness mastery assessment, has customizable reminders which the patient will learn to set during orientation, and goal-setting and tracking features, which the patient will learn to customize during orientation. Mindfulness Coach was designed by a multidisciplinary team of experts in telehealth, technology and mental health from the VA's National Center for PTSD and the Department of Defense's National Center for Telehealth and Technology and is free and available on iOS and Android. In this study, the intervention will be introduced during 1 in-person session by a trained research assistant with 1-2 booster instructional phone call at 7 and 14-days to ensure that the participant knows how and is encouraged to use the app. The participant will also be provided with a laminated card that provides the basic instructions. The investigators will encourage the participant to use Mindfulness Coach weekly for 8 weeks, or more if desired, as this treatment dose is commensurate with most in-person MT psychotherapy treatment protocols.
Subjects and Sample Size:The investigators will recruit 60 patients from three RWJ Barnabas sites: Monmouth, Monroe and New Brunswick. Caregivers will be recruited by physician referral. Physicians will identify patients with a diagnosis of dementia or cognitive impairment and their family caregivers. The term "family caregiver" refers to any family member or relative who is involved in a patient's health care because of a personal connection, not for financial compensation. Family caregivers are eligible if they are age 21 or older, English-speaking, currently own a mobile device (smartphone or tablet) and spend at least 10 hours per week providing care to the older adult patient. Procedures: Providers will notify study coordinator of patients who have a diagnosis of dementia or cognitive impairment and typically have a family caregiver present during medical visits. Emails will be sent to providers to inquire about potential subjects. The study research assistant (RA) will call potential subjects to obtain consent for a phone screen. The screen will include questions about current caregiving practices and questions about mobile device usage (e.g., do participants own a smart phone or tablet? How often do participants use this device?). If a patient is eligible and interested in participating, an in-person baseline assessment and orientation will be scheduled at the primary care provider's office. Informed consent will be obtained in person prior to the baseline assessment. The baseline assessor will also be the individual who orients participants to Mindfulness Coach. Follow-up interviews will be conducted via telephone.
The orientation will consist of the following components: 1.) education about the app, its developers and MT (to establish credibility); 2.) discussion of goals of the app; 3.) procedural information about how to launch and navigate the app; and 4.) assessment of participant's ability to use the app: participants must be able to meet pre-established criteria of being able to open, launch, navigate and use the app independently prior to the end of the orientation session. During orientation, study personnel will discuss the benefits of daily, brief (5-15 minutes) mindfulness practice and ask participants if daily practice is a goal they would be willing to set. If the participant is amenable, study personnel will help participants set reminders (push notifications) within Mindfulness Coach to facilitate daily practice. The investigators will work with each participant to set mindfulness practice goals that are tailored to the unique needs of each participant. Participants will also be given a laminated instructional card explaining how to access and use Mindfulness Coach. Booster sessions: The study RA will schedule a 1-week booster phone call with intervention participants to troubleshoot potential difficulties users may be experiencing with the application. At this session, participants will be asked if they have used the app in their first week. If they have not, the investigators will schedule an additional follow up booster session phone call at 2-weeks to provide additional troubleshooting and encouragement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindfulness CoachEveryone in the study will get Mindfulness Coach and an orientation session. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The intervention will be introduced during 1 in-person session by a trained research assistant with 1-2 booster instructional phone call at 7 and 14-days to ensure that the participant knows how and is encouraged to use the app. The participant will also be provided with a laminated card that provides the basic instructions. We will encourage the participant to use Mindfulness Coach weekly for 8 weeks, or more if desired, as this treatment dose is commensurate with most in-person MT psychotherapy treatment protocols. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- owns a smart phone or tablet
- speaks English fluently, aged 21+
- identifies as the caregiver for an older adult with dementia or mild cognitive impairment
Key exclusion criteria (4 listed)
- does not own smart phone or tablet
- does not speak English fluently
- is under age 21
- does not provide care for older adult with dementia or mild cognitive impairment.
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 |
|---|---|---|
| Mindfulness CoachMindfulness Coach is an mHealth delivered mindfulness therapy. | Behavioural | Intervention |
Primary outcome
Feasibility - amount of time participants spend in app
Time frame: 8 weeks
how much do caregivers use mindfulness coach
Acceptability - satisfaction with mindfulness coach survey
Time frame: 8 weeks
Do caregivers find mindfulness coach helpful and easy to use?
Bakas Caregiver Outcomes Scale - 15 items
Time frame: 8 weeks
scores range from 15-105 with higher scores indicating better outcomes
4 secondary outcomes
hospital anxiety and depression scale- anxiety sub scale
Time frame: 8 weeks
hospital anxiety and depression scale, depression sub scale
Time frame: 8 weeks
The World Health Organization Quality of Life Brief
Time frame: 8 weeks
perceived stress scale
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Coach in people with Caregiver Burnout and Stress, run by Rutgers, The State University of New Jersey at 2 sites 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 3 inclusion and 4 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 - amount of time participants spend in app (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2021.