Skip to content

Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being

Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03506945
Enrollment
184
Registered
2018-04-24
Start date
2018-11-01
Completion date
2024-05-31
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms, Stress, Psychological

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

BEHAVIORALmPEP

Behavioral Activation Therapy

BEHAVIORALBibliotherapy

Provide educational material on coping strategies pertinent to caregivers

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Center for Epidemiologic Studies Depression Scale--Revised (CESD-R)15-months20 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

MeasureTime frameDescription
Positive and Negative Affect Scale (PANAS)15-monthsPositive 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 Pressure15-monthsSystolic and Diastolic Blood Pressure
Dementia Quality of Life Scale for Older Family Carers (DQoLOC)15-monthsDementia 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

ArmCount
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
Total184

Baseline characteristics

CharacteristicPsychoeducationMobile Pleasant Events Program (mPEP)Total
Age, Continuous63.1 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 Pressure75.8 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 Participants5 Participants17 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
70 Participants72 Participants142 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants16 Participants25 Participants
Negative Affect22.1 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 Affect28.4 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 Life60.3 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 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
5 Participants8 Participants13 Participants
Race (NIH/OMB)
Black or African American
4 Participants3 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants16 Participants25 Participants
Race (NIH/OMB)
White
71 Participants65 Participants136 Participants
Sex: Female, Male
Female
82 Participants80 Participants162 Participants
Sex: Female, Male
Male
9 Participants13 Participants22 Participants
Systolic Blood Pressure122.4 mmHg
STANDARD_DEVIATION 17.8
124.8 mmHg
STANDARD_DEVIATION 17.8
123.7 mmHg
STANDARD_DEVIATION 17.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 931 / 91
other
Total, other adverse events
12 / 9313 / 91
serious
Total, serious adverse events
0 / 930 / 91

Outcome results

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.

Time frame: 15-months

Population: Participants in each group dropped out or were lost to follow-up

ArmMeasureValue (MEAN)Dispersion
mPEPCenter for Epidemiologic Studies Depression Scale--Revised (CESD-R)16.9 Score on a scaleStandard Error 1.6
BibliotherapyCenter for Epidemiologic Studies Depression Scale--Revised (CESD-R)14.9 Score on a scaleStandard Error 1.8
Secondary

Blood Pressure

Systolic and Diastolic Blood Pressure

Time frame: 15-months

ArmMeasureGroupValue (MEAN)Dispersion
mPEPBlood PressureSystolic Blood Pressure123.4 mmHgStandard Error 2.1
mPEPBlood PressureDiastolic Blood Pressure75.8 mmHgStandard Error 1.2
BibliotherapyBlood PressureSystolic Blood Pressure121.3 mmHgStandard Error 1.9
BibliotherapyBlood PressureDiastolic Blood Pressure76.0 mmHgStandard Error 1.3
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.

Time frame: 15-months

Population: Participant withdrawal and lost to follow-up

ArmMeasureValue (MEAN)Dispersion
mPEPDementia Quality of Life Scale for Older Family Carers (DQoLOC)63.5 Score on a scaleStandard Error 1.9
BibliotherapyDementia Quality of Life Scale for Older Family Carers (DQoLOC)64.8 Score on a scaleStandard Error 2
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.

Time frame: 15-months

ArmMeasureGroupValue (MEAN)Dispersion
mPEPPositive and Negative Affect Scale (PANAS)Positive Affect30.0 Scores on a scaleStandard Error 0.97
mPEPPositive and Negative Affect Scale (PANAS)Negative Affect20.4 Scores on a scaleStandard Error 0.95
BibliotherapyPositive and Negative Affect Scale (PANAS)Positive Affect29.8 Scores on a scaleStandard Error 0.98
BibliotherapyPositive and Negative Affect Scale (PANAS)Negative Affect19.5 Scores on a scaleStandard Error 0.98

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026