Depressive SymptomsNCT03506945
Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
A study testing mPEP and Bibliotherapy in people with Depressive Symptoms and Stress, Psychological, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Stress, Psychological
- What is being tested?
- mPEP and Bibliotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 May 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
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.
Read the 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.
- Conditions
- Depressive Symptoms, Stress, Psychological
- Being tested
- mPEP, Bibliotherapy
- Medical subject headings
- Depression, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPEPBehavioural
Behavioral Activation Therapy
BibliotherapyBehavioural
Provide educational material on coping strategies pertinent to caregivers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: mPEP |
| 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. Receives: Behavioral: Bibliotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15-months
Secondary outcomes (3)
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.
Measured: 15-months
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: 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.
Measured: 15-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Nov 2018
- Primary completion31 May 2024
- Study completion31 May 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 Depressive SymptomsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Mausbach, University of California, San Diego
- Investigators
- Brent T Mausbach, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506945
- Sponsor's protocol ID
- 180454
- Other IDs
- R01AG061941
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2018
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
- ClinicalTrials.gov ID
- NCT03506945
- Acronym / sponsor ID
- 180454
- Conditions
- Depressive Symptoms, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mPEP | Experimental | Behavioral: mPEPBehavioral 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 | Behavioral: BibliotherapyBibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| mPEPBehavioral Activation Therapy | Behavioural | mPEP |
| BibliotherapyProvide educational material on coping strategies pertinent to caregivers | Behavioural | Bibliotherapy |
Primary outcome
Center for Epidemiologic Studies Depression Scale--Revised (CESD-R)
Time frame: 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.
3 secondary outcomes
Positive and Negative Affect Scale (PANAS)
Time frame: 15-months
Blood Pressure
Time frame: 15-months
Dementia Quality of Life Scale for Older Family Carers (DQoLOC)
Time frame: 15-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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.
Brent T Mausbach, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPEP and Bibliotherapy in people with Depressive Symptoms and Stress, Psychological, run by University of California, San Diego 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 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: finished, as of the sponsor's last update on 24 Oct 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. 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 24 Oct 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?
Center for Epidemiologic Studies Depression Scale--Revised (CESD-R) (time frame: 15-months). 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 Oct 2025.