Depressive Symptoms, Stress, Psychological
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Behavioral Activation Therapy
Provide educational material on coping strategies pertinent to caregivers
Sponsors
Study design
Eligibility
Inclusion criteria
- * English-speaking * Spouse or Child Caregiver of a loved-one with Alzheimer's Disease or Related Dementia (ADRD) * Aged 40 years or older at the time of enrollment * Providing at least 20 hours of in-home care per week * Screening positive for mild depressive symptoms (CESD-R≥16).
Exclusion criteria
- * Diagnosed with a terminal illness * Demonstrates cognitive impairment (MMSE\<27) * Severe hypertension (\>200/120 mm Hg) * Participating in another active caregiver intervention (other than support groups) * Receiving psychiatric care for serious mental illnesses such as schizophrenia or bipolar disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale--Revised (CESD-R) | 15-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect Scale (PANAS) | 15-months | 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. |
| Blood Pressure | 15-months | Systolic and Diastolic Blood Pressure |
| Dementia Quality of Life Scale for Older Family Carers (DQoLOC) | 15-months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 93 |
| 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). | 91 |
| Total | 184 |
Baseline characteristics
| Characteristic | Psychoeducation | Mobile Pleasant Events Program (mPEP) | Total |
|---|---|---|---|
| Age, Continuous | 63.1 Years STANDARD_DEVIATION 11.2 | 64.5 Years STANDARD_DEVIATION 11.3 | 63.8 Years STANDARD_DEVIATION 11.2 |
| Center For Epidemiologic Studies Depression Scale - Revised (CESD-R) | 19.0 Scores on a Scale STANDARD_DEVIATION 13.2 | 19.7 Scores on a Scale STANDARD_DEVIATION 13.7 | 19.4 Scores on a Scale STANDARD_DEVIATION 13.4 |
| Diastolic Blood Pressure | 75.8 mmHg STANDARD_DEVIATION 10.1 | 78.9 mmHg STANDARD_DEVIATION 7.8 | 77.4 mmHg STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 5 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 72 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 16 Participants | 25 Participants |
| Negative Affect | 22.1 Scores on a Scale STANDARD_DEVIATION 6.4 | 22.7 Scores on a Scale STANDARD_DEVIATION 7.5 | 22.4 Scores on a Scale STANDARD_DEVIATION 7 |
| Positive Affect | 28.4 Scores on a Scale STANDARD_DEVIATION 6.3 | 28.4 Scores on a Scale STANDARD_DEVIATION 7.1 | 28.4 Scores on a Scale STANDARD_DEVIATION 6.7 |
| Quality of Life | 60.3 Scores on a Scale STANDARD_DEVIATION 11.9 | 60.2 Scores on a Scale STANDARD_DEVIATION 12.4 | 60.2 Scores on a Scale STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 16 Participants | 25 Participants |
| Race (NIH/OMB) White | 71 Participants | 65 Participants | 136 Participants |
| Sex: Female, Male Female | 82 Participants | 80 Participants | 162 Participants |
| Sex: Female, Male Male | 9 Participants | 13 Participants | 22 Participants |
| Systolic Blood Pressure | 122.4 mmHg STANDARD_DEVIATION 17.8 | 124.8 mmHg STANDARD_DEVIATION 17.8 | 123.7 mmHg STANDARD_DEVIATION 17.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 1 / 91 |
| other Total, other adverse events | 12 / 93 | 13 / 91 |
| serious Total, serious adverse events | 0 / 93 | 0 / 91 |
Outcome results
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.
Time frame: 15-months
Population: Participants in each group dropped out or were lost to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mPEP | Center for Epidemiologic Studies Depression Scale--Revised (CESD-R) | 16.9 Score on a scale | Standard Error 1.6 |
| Bibliotherapy | Center for Epidemiologic Studies Depression Scale--Revised (CESD-R) | 14.9 Score on a scale | Standard Error 1.8 |
Blood Pressure
Systolic and Diastolic Blood Pressure
Time frame: 15-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mPEP | Blood Pressure | Systolic Blood Pressure | 123.4 mmHg | Standard Error 2.1 |
| mPEP | Blood Pressure | Diastolic Blood Pressure | 75.8 mmHg | Standard Error 1.2 |
| Bibliotherapy | Blood Pressure | Systolic Blood Pressure | 121.3 mmHg | Standard Error 1.9 |
| Bibliotherapy | Blood Pressure | Diastolic Blood Pressure | 76.0 mmHg | Standard Error 1.3 |
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.
Time frame: 15-months
Population: Participant withdrawal and lost to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| mPEP | Dementia Quality of Life Scale for Older Family Carers (DQoLOC) | 63.5 Score on a scale | Standard Error 1.9 |
| Bibliotherapy | Dementia Quality of Life Scale for Older Family Carers (DQoLOC) | 64.8 Score on a scale | Standard Error 2 |
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.
Time frame: 15-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| mPEP | Positive and Negative Affect Scale (PANAS) | Positive Affect | 30.0 Scores on a scale | Standard Error 0.97 |
| mPEP | Positive and Negative Affect Scale (PANAS) | Negative Affect | 20.4 Scores on a scale | Standard Error 0.95 |
| Bibliotherapy | Positive and Negative Affect Scale (PANAS) | Positive Affect | 29.8 Scores on a scale | Standard Error 0.98 |
| Bibliotherapy | Positive and Negative Affect Scale (PANAS) | Negative Affect | 19.5 Scores on a scale | Standard Error 0.98 |