CaregiversCARINGNCT03857308
Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
A study testing Mindfulness Training and Reappraisal Training in people with Caregivers and Burnout, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Burnout, Sleep
- What is being tested?
- Mindfulness Training and Reappraisal Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 25 Mar 2020
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Self-reporting informal caregivers of persons with dementia
Who cannot join
- Self-reported major depressive disorder with psychotic features
- History of schizophrenia
- Bipolar disorder
- Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
- Previous MBSR training or regular meditative practice within previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.
Read the detailed description
The research project will be conducted over approximately 9 months and will consist of three data collection sessions for each participant. The three data sessions will occur before, after, and at 3-month follow-up of an 14-day, online stress-reduction training, in which participants will be asked to complete about 25 to 30 minutes of practice each day in one of two stress-reduction techniques. Participants will be randomly assigned to either a mindfulness training program or a reappraisal training program. The mindfulness training emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas the reappraisal training emphasizes cognitive strategies to change one's perception of the stressor as a way to reduce stress and promote well-being.
- Conditions
- Caregivers, Burnout, Sleep
- Being tested
- Mindfulness Training, Reappraisal Training
- Keywords
- well-being, sleep, caregiver
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
This stress reduction training will last 14 days and teach participants skills in concentration, monitoring of present-moment bodily experience, and acceptance of experience. Participants are encouraged to "mentally welcome" all physical and emotional experience. Each day will consist of approximately 25 to 30 minutes of training.
A full explanation of the mindfulness training compared to the reappraisal training could interfere with study blinding procedures. A complete description can be provided after data collection is complete.
Reappraisal TrainingBehavioural
Also called My Time
This stress reduction training will last 14-days. Each day consists of 25 to 30 minutes of daily practice in "Coping control." Participants are encouraged to reframe and reappraise life events, both past and present, and encouraged to solve personal problems through active change.
A full explanation of the reappraisal stress reduction program compared to the mindfulness program could interfere with study blinding procedures. A complete description can be provided after data collection is complete.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training | Experimental | Not described Receives: Behavioral: Mindfulness Training |
| Reappraisal Training | Active comparator | Not described Receives: Behavioral: Reappraisal Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eudaimonic well-being
54 item self-reported scale assessing change in eudaimonic well-being from pre to post-intervention. Will be assessed using the Scales of Psychologica Well-being (SPWB; Ryff \& Keyes, 1995)
1 = strongly disagree, 6 = strongly agree. This scale range applies for the 6 subscales, which can stand-alone, or be summed to obtain a total Eudaimonic Well-Being score. For this study, we are primarily interested in investigated changes over time of the summed score for eudaimonic well-being. Higher scores indicate higher eudaimonic well-being.
Measured: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Change in Sleep Quality
We will use a sleep diary that involves self-reported sleep habits, which we will use to calculate sleep onset, wake after sleep onset, and sleep efficiency. This will allow us to understand any changes in overall sleep quality across the intervention.
Measured: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Change in Sleep Quality: Actigraph
Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.
Measured: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Secondary outcomes (1)
Change in Relationship Quality
The Mutuality Scale of Family Care Inventory (Archbold, Stewart, Greenlick, \& Harvath, 1990) will be used to assess for change in caregiver/care recipient relationship quality. It is a 15-item self-report measure to assess caregiver's perceived relationship quality with the care recipient. The scale items range in score from 1 to 4, with higher scores indicating greater relationship quality. Items are summed to create a total score.
Measured: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start13 Nov 2019
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Why it stopped: Unable to continue enrollment for dissertation study due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Dzierzewski, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857308
- Sponsor's protocol ID
- HM20011802
- Acronym
- CARING
- Status last verified
- Apr 2020
- First submitted
- 7 Jan 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
- ClinicalTrials.gov ID
- NCT03857308
- Acronym / sponsor ID
- CARING / HM20011802
- Conditions
- Caregivers, Burnout, Sleep
- Keywords
- well-being, sleep, caregiver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to continue enrollment for dissertation study due to COVID-19
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 27 Feb 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.
This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.
Detailed description
The research project will be conducted over approximately 9 months and will consist of three data collection sessions for each participant. The three data sessions will occur before, after, and at 3-month follow-up of an 14-day, online stress-reduction training, in which participants will be asked to complete about 25 to 30 minutes of practice each day in one of two stress-reduction techniques. Participants will be randomly assigned to either a mindfulness training program or a reappraisal training program. The mindfulness training emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas the reappraisal training emphasizes cognitive strategies to change one's perception of the stressor as a way to reduce stress and promote well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Experimental | Behavioral: Mindfulness Training |
| Reappraisal Training | Active comparator | Behavioral: Reappraisal Training |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking
- Self-reporting informal caregivers of persons with dementia
Key exclusion criteria (5 listed)
- Self-reported major depressive disorder with psychotic features
- History of schizophrenia
- Bipolar disorder
- Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
- Previous MBSR training or regular meditative practice within previous 6 months
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 TrainingThis stress reduction training will last 14 days and teach participants skills in concentration, monitoring of present-moment bodily experience, and acceptance of experience. Participants are encouraged to "mentally welcome" all physical and emotional experience. Each day will consist of approximately 25 to 30 minutes of training. A full explanation of the mindfulness training compared to the reappraisal training could interfere with study blinding procedures. A complete description can be provided after data collection is complete. | Behavioural | Mindfulness Training |
| Reappraisal TrainingAlso: My TimeThis stress reduction training will last 14-days. Each day consists of 25 to 30 minutes of daily practice in "Coping control." Participants are encouraged to reframe and reappraise life events, both past and present, and encouraged to solve personal problems through active change. A full explanation of the reappraisal stress reduction program compared to the mindfulness program could interfere with study blinding procedures. A complete description can be provided after data collection is complete. | Behavioural | Reappraisal Training |
Primary outcome
Change in Eudaimonic well-being
Time frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
54 item self-reported scale assessing change in eudaimonic well-being from pre to post-intervention. Will be assessed using the Scales of Psychologica Well-being (SPWB; Ryff \& Keyes, 1995) 1 = strongly disagree, 6 = strongly agree. This scale range applies for the 6 subscales, which can stand-alone, or be summed to obtain a total Eudaimonic Well-Being score. For this study, we are primarily interested in investigated changes over time of the summed score for eudaimonic well-being. Higher scores indicate higher eudaimonic well-being.
Change in Sleep Quality
Time frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
We will use a sleep diary that involves self-reported sleep habits, which we will use to calculate sleep onset, wake after sleep onset, and sleep efficiency. This will allow us to understand any changes in overall sleep quality across the intervention.
Change in Sleep Quality: Actigraph
Time frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Actigraphic measure of limb movements used to calculate sleep efficiency, which is an assessment of the quality of sleep participants have.
1 secondary outcome
Change in Relationship Quality
Time frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Results and safety
The study was stopped early (reason given: Unable to continue enrollment for dissertation study due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
Joseph Dzierzewski, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training and Reappraisal Training in people with Caregivers and Burnout, run by Virginia Commonwealth University 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Apr 2020. 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?
The study was stopped early (reason given: Unable to continue enrollment for dissertation study due to COVID-19). Results are not available in the source record.
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?
Change in Eudaimonic well-being (time frame: Baseline to 2-weeks (post-intervention), and 3-month follow-up). 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 24 Apr 2020.