StressNCT04603482
Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)
A study testing Resourcefulness training and Biofeedback in people with Stress and Carer Stress Syndrome, run by Case Western Reserve University at 1 site in United States.
Trial summary
How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Carer Stress Syndrome, Dementia
- What is being tested?
- Resourcefulness training and Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 30 Jun 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia
- Identify self as a primary caregiver
- In-home Caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc.
- Be capable of performing informed consent and participating in study procedures
Who cannot join
- Does not have a family member with Alzheimer's disease or another dementia
- Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 months
- Has knowledge of another family member in the same household enrolled in the study
- Currently pregnant
- Has a pacemaker
- Lives outside of the study area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).
Read the detailed description
The study has two aims: The primary aim (A1) is to examine differences across the three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the attention control.
Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions.
All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference.
Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.
- Conditions
- Stress, Carer Stress Syndrome, Dementia, Alzheimer's Disease, Bereavement
- Being tested
- Resourcefulness training, Biofeedback, Attention Control
- Keywords
- Caregiver, Biofeedback, Resourcefulness, Self-Management
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resourcefulness trainingBehavioural
Resourcefulness training is a cognitive behavioral intervention that consists of teaching and reinforcing personal (self-help) and social (help-seeking) strategies to overcome adversity.
BiofeedbackBehavioural
Biofeedback training combines teaching slow, deep, paced breathing with real-time tracking to increase an individual's heart rate variability and ultimately improve self-regulation.
Attention ControlBehavioural
Participants randomly assigned to this intervention will receive suggested Diversional Activities, presented in an audiovisual format.
| Study group | Role | What they receive |
|---|---|---|
| Self-management intervention based on Need | Active comparator | Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to baseline data. Receives: Behavioral: Resourcefulness training; Behavioral: Biofeedback |
| Self-management intervention based on Preference | Active comparator | Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to their preference. Receives: Behavioral: Resourcefulness training; Behavioral: Biofeedback |
| Attention Control: Diversonal Activities | Placebo comparator | Participants randomly assigned to this arm will be presented with diversional activities. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver's Perceived Stress Scale
14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress
Measured: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in Caregiver's Negative Emotions Checklist
10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions.
Measured: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in Caregiver's Depressive Cognitions Scales
8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition
Measured: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)
Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Measured: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Measured: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in Caregiver's Health Risk Behavior Scale
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
Measured: From T1 (baseline) to T2 (6 months) through T3 (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start8 Jan 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclene A. Zauszniewski, Case Western Reserve University
- Investigators
- Jaclene A Zauszniewski, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603482
- Sponsor's protocol ID
- R01NR018476
- Status last verified
- May 2025
- First submitted
- 21 Oct 2020
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
- ClinicalTrials.gov ID
- NCT04603482
- Acronym / sponsor ID
- R01NR018476
- Conditions
- Stress, Carer Stress Syndrome, Dementia, Alzheimer's Disease, Bereavement
- Keywords
- Caregiver, Biofeedback, Resourcefulness, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).
Detailed description
The study has two aims: The primary aim (A1) is to examine differences across the three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the attention control.
Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions.
All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference.
Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-management intervention based on Need | Active comparator | Behavioral: Resourcefulness training, Behavioral: BiofeedbackParticipants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to baseline data. |
| Self-management intervention based on Preference | Active comparator | Behavioral: Resourcefulness training, Behavioral: BiofeedbackParticipants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to their preference. |
| Attention Control: Diversonal Activities | Placebo comparator | Behavioral: Attention ControlParticipants randomly assigned to this arm will be presented with diversional activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia
- Identify self as a primary caregiver
- In-home Caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc.
- Be capable of performing informed consent and participating in study procedures
Key exclusion criteria (6 listed)
- Does not have a family member with Alzheimer's disease or another dementia
- Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 months
- Has knowledge of another family member in the same household enrolled in the study
- Currently pregnant
- Has a pacemaker
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 |
|---|---|---|
| Resourcefulness trainingResourcefulness training is a cognitive behavioral intervention that consists of teaching and reinforcing personal (self-help) and social (help-seeking) strategies to overcome adversity. | Behavioural | Self-management intervention based on Need, Self-management intervention based on Preference |
| BiofeedbackBiofeedback training combines teaching slow, deep, paced breathing with real-time tracking to increase an individual's heart rate variability and ultimately improve self-regulation. | Behavioural | Self-management intervention based on Need, Self-management intervention based on Preference |
| Attention ControlParticipants randomly assigned to this intervention will receive suggested Diversional Activities, presented in an audiovisual format. | Behavioural | Attention Control: Diversonal Activities |
Primary outcome
Change in Caregiver's Perceived Stress Scale
Time frame: From T1 (baseline) to T2 (6 months) through T3 (one year)
14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress
Change in Caregiver's Negative Emotions Checklist
Time frame: From T1 (baseline) to T2 (6 months) through T3 (one year)
10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions.
Change in Caregiver's Depressive Cognitions Scales
Time frame: From T1 (baseline) to T2 (6 months) through T3 (one year)
8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition
Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)
Time frame: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
Time frame: From T1 (baseline) to T2 (6 months) through T3 (one year)
Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Change in Caregiver's Health Risk Behavior Scale
Time frame: From T1 (baseline) to T2 (6 months) through T3 (one year)
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Jaclene A Zauszniewski, PhD principal investigator
Case Western Reserve 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 Resourcefulness training and Biofeedback in people with Stress and Carer Stress Syndrome, run by Case Western Reserve 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 5 inclusion and 6 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 13 May 2025. 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. Some participants in this study may receive a placebo. 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 18 Mar 2025). 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?
Change in Caregiver's Perceived Stress Scale (time frame: From T1 (baseline) to T2 (6 months) through T3 (one year)). The study lists 6 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 13 May 2025.