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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG061941 | U.S. NIH Grant/Contract | View source |
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Caregivers suffer great amounts of distress that significantly impacts their mental and physical well-being, yet caregivers' access to quality, evidence-based care is currently very limited. The public health significance of the proposed study is that our internet and mobile-based web intervention will (1) significantly reduce caregiver distress and improve caregivers' overall well-being, and (2) dramatically increase caregivers' access to high quality, evidence-based care at relatively low cost.
Over 15 million men and women provide informal caregiving services to family members who have dementia. The literature is replete with evidence that caregiving results in high rates of depression and distress, and potentially high rates of physical morbidity. For example, 40% of caregivers are at risk for depression compared to just 5% of non-caregiving older adults. Further, increased symptoms of depression and distress in caregivers are associated with accelerated risk for developing cardiovascular disease. Thus, efficacious interventions for reducing caregiver distress appear potentially valuable for both mental and physical well-being.
Given the distress experienced by caregivers, it is no surprise that over 80 intervention studies for reducing caregiver distress have been published. The message from these studies is that caregiver interventions, in general, are effective for reducing distress. Yet, the implementation of Evidence Based Treatments (EBTs) continues to be a challenge. Despite identification of EBTs, their use at the community-level has been absent. In 2007, NIH sponsored a workshop on the use of EBTs for caregivers. The conclusion was that "The majority of effective interventions for caregivers were not being implemented through the aging network." Ten years later, this lack of implementation remains. It is critical that scientists develop interventions for caregivers with maximal reach and minimal cost. Currently, most caregiver intervention frameworks require caregivers to meet with a therapist in one of four formats: a) face-to-face meetings with a therapist outside the caregiver's home, b) face-to-face meetings with a therapist in the caregiver's home, c) in-person, group-based meetings, or d) phone-based interventions in which caregivers call a therapist or support group. While possibly efficacious, these therapeutic formats are limited because: a) community agencies serving caregivers do not offer EBTs, b) the interventions are often not accessible to caregivers who reside outside the care network, c) they require caregivers to attend therapy sessions on specific days and times that may not be convenient for them, or d) they may require caregivers to find alternate care for their care recipients while they attend the therapy. To address these limitations, the investigators have adapted an evidence-based, brief Behavioral Activation (BA) program to be delivered to caregivers via mobile phones with internet-based capabilities, thereby increasing caregivers' access to quality care. This mobile intervention is now being tested in this full-scale trial. The investigators will test mechanisms of action, namely that increased behavioral activation promotes well-being in caregivers. To do so, the investigators will recruit and randomize 200 caregivers to receive either a mobile BA intervention (N = 100) known as the mobile pleasant events program (mPEP), or a web-based bibliotherapy condition (N = 100) teaching skills on coping with caregiving. Participants will be assessed for depressive symptoms, positive and negative affect, well-being, and blood pressure at baseline, 3-months, 9-months, and 15-months follow-up time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mPEP | Experimental | Behavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis. |
|
| Bibliotherapy | Active Comparator | Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mPEP | Behavioral | Behavioral Activation Therapy |
| |
| Bibliotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale--Revised (CESD-R) | 20 item scale measuring Depressive Symptoms. Each item rated on a range of 0-4 and items are summed to create a total score (Range = 0-80). Higher scores denote greater depressive symptoms. | 15-months |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Affect Scale (PANAS) | Positive and Negative Affect Scale (PANAS). There are 10 items asking about Positive Affect, each item is rated on a range of 1-5. All 10 items are summed to create a total score (Range = 10-50) There are 10 items asking about Negative Affect, each item is rated from 1-5, and items are summed to create an overall score (Range = 10-50). Higher scores denote greater positive and negative affect, respectively. |
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Inclusion Criteria -
Exclusion Criteria -
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| Name | Affiliation | Role |
|---|---|---|
| Brent T Mausbach, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States |
Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. The PI will determine who is authorized to have copies of what types of data and when the data will be available. Publicizing availability of the data after main results from the study have been published, and providing a USB or CD containing the data to individuals who express interest, will ensure that maximum data sharing occurs. We will make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology; and (3) a commitment to destroy or return the data after analyses are completed.
Within 12 months of close of the trial
The PI will determine who is authorized to have copies of what types of data and when the data will be available. Publicizing availability of the data after main results from the study have been published, and providing a USB or CD containing the data to individuals who express interest, will ensure that maximum data sharing occurs.
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Recruitment centered on community providers and research organizations serving caregivers and persons with dementia, as well as community-based caregiver support groups. Further recruitment occurred via digital and print advertisement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Pleasant Events Program (mPEP) | This arm consists of 12 weeks of behavioral activation therapy delivered via smart phone or smart device (e.g., iPAD). |
| FG001 | Psychoeducation | This arm consists of 12 weeks of digital psychoeducation consisting of a comprehensive resource guide containing materials on coping with specific caregiver stresses (e.g., developing problem-solving skills; managing care receiver problem behaviors; improving communication). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Pleasant Events Program (mPEP) | This arm consists of 12 weeks of behavioral activation therapy delivered via smart phone or smart device (e.g., iPAD). |
| BG001 | Psychoeducation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Center for Epidemiologic Studies Depression Scale--Revised (CESD-R) | 20 item scale measuring Depressive Symptoms. Each item rated on a range of 0-4 and items are summed to create a total score (Range = 0-80). Higher scores denote greater depressive symptoms. | Participants in each group dropped out or were lost to follow-up | Posted | Mean | Standard Error | Score on a scale | 15-months |
|
From enrollment until 15 months
Clinical Trials definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mPEP | Behavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Progression of Dementia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brent Mausbach | University of California San Diego | 8588227529 | bmausbach@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2019 | Sep 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001638 | Bibliotherapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Behavioral |
Provide educational material on coping strategies pertinent to caregivers |
|
| 15-months |
| Blood Pressure | Systolic and Diastolic Blood Pressure | 15-months |
| Dementia Quality of Life Scale for Older Family Carers (DQoLOC) | Dementia Quality of Life Scale for Older Family Carers (DQoLOC). Scale consists of 22 items, each item is rated from 1-5. The total range for the scale is 22-110, with higher score indicating greater quality of life. | 15-months |
This arm consists of 12 weeks of digital psychoeducation consisting of a comprehensive resource guide containing materials on coping with specific caregiver stresses (e.g., developing problem-solving skills; managing care receiver problem behaviors; improving communication).
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Center For Epidemiologic Studies Depression Scale - Revised (CESD-R) | Scale consists of 20 questions with individual item responses ranging from 0-4 (total range for scale is 0-80, with higher score indicating greater depression) | Mean | Standard Deviation | Scores on a Scale |
|
| Positive Affect | Positive and Negative Affect Scale (PANAS) - Positive Affect Score. Scale consists of 10 items, individual items rated from 1-5 (total range for scale = 10-50, with higher score indicating greater positive affect) | Mean | Standard Deviation | Scores on a Scale |
|
| Negative Affect | Positive and Negative Affect Scale (PANAS) - Negative Affect Score. Scale consists of 10 items, individual items rated from 1-5 (total range for scale = 10-50, with higher score indicating greater negative affect. | Mean | Standard Deviation | Scores on a Scale |
|
| Quality of Life | Dementia Quality of Life Scale for Older Family Carers (DQoLOC). Scale consists of 22 items, each item is rated from 1-5. The total range for the scale is 22-110, with higher score indicating greater quality of life. | Mean | Standard Deviation | Scores on a Scale |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Bibliotherapy |
Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems. |
|
|
| Secondary | Positive and Negative Affect Scale (PANAS) | Positive and Negative Affect Scale (PANAS). There are 10 items asking about Positive Affect, each item is rated on a range of 1-5. All 10 items are summed to create a total score (Range = 10-50) There are 10 items asking about Negative Affect, each item is rated from 1-5, and items are summed to create an overall score (Range = 10-50). Higher scores denote greater positive and negative affect, respectively. | Posted | Mean | Standard Error | Scores on a scale | 15-months |
|
|
|
| Secondary | Blood Pressure | Systolic and Diastolic Blood Pressure | Posted | Mean | Standard Error | mmHg | 15-months |
|
|
|
| Secondary | Dementia Quality of Life Scale for Older Family Carers (DQoLOC) | Dementia Quality of Life Scale for Older Family Carers (DQoLOC). Scale consists of 22 items, each item is rated from 1-5. The total range for the scale is 22-110, with higher score indicating greater quality of life. | Participant withdrawal and lost to follow-up | Posted | Mean | Standard Error | Score on a scale | 15-months |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 12 |
| 93 |
| EG001 | Bibliotherapy | Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems. | 1 | 91 | 0 | 91 | 13 | 91 |
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| D013812 |
| Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |