DepressionNCT04428112
Rural Dementia Caregiver Project
A study testing Building Better Caregivers Workshop in people with Depression and Stress, Psychological, run by University of California, San Francisco at 1 site in United States.
Trial summary
Rural caregivers face challenges of geographic isolation and lower health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Stress, Psychological, Self Efficacy
- What is being tested?
- Building Better Caregivers Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to 16 Oct 2023
- 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
- Aged 18 years or older
- Caring for person with dementia
- Able to read and write in English
- Able to access the internet
- Providing care for ≥ 10 hours per week
- Reporting a minimum stress level of 4 or more on a 10-point scale
- Living in rural area of United States (self-identify or zip code is a Rural Urban Commuting Area Codes (RUCA) defined rural area)
Who cannot join
- Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias
Rural caregivers face challenges of geographic isolation and lower health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers.
Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia.
Read more
The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depressive symptoms. The investigators hypothesize that stress scores and depressive symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations.
If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).
- Conditions
- Depression, Stress, Psychological, Self Efficacy, Loneliness, Social Isolation, Health Care Utilization
- Being tested
- Building Better Caregivers Workshop, Attention Control
- Keywords
- Caregiver, Caregiving
- Medical subject headings
- Depression, Stress, Psychological, Social Isolation, Patient Acceptance of Health Care, Dementia, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Better Caregivers WorkshopBehavioural
Workshops consist of small group or about 20-25 persons. Two peer co-facilitators (caregiver themselves) will guide workshop activities. Participants will receive a workshop booklet. Each week, participants will log on at least 2-3 times for a total time of approximately two hours. Participants do not require "real time" attendance at pre-determined times.
Attention ControlBehavioural
Participants will receive two brief 15-30 minutes phone calls by study staff, and will receive a handbook on dementia and caregiver resources while they wait for the workshop.
| Study group | Role | What they receive |
|---|---|---|
| Building Better Caregivers Workshop Group | Experimental | Building Better Caregivers Workshop is a 6-week online self-management and skills building workshop. Participants receive the online workshop as soon as possible after randomization. Receives: Behavioral: Building Better Caregivers Workshop |
| Attention Control Group | Active comparator | Participants will be offered the online workshop after the 12 month trial is completed if they so desire. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Health Questionnaire Depression (PHQ-8) Scale Score
Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Measured: 12 months
Visual Numeric Stress Scale
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
Measured: 12 months
Secondary outcomes (9)
Personal Health Questionnaire Depression (PHQ-8) Scale Score
Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Measured: 6 months
Visual Numeric Stress Scale Score
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
Measured: 6 months
Short Caregiver Self-Efficacy Scale Score
Short Caregiver Self-Efficacy scale (8-items). The scale scores is calculated by taking the mean of the items to produce a total score between 1 and 10, with higher scores indicating better outcome.
Measured: 12 months
Zarit Burden Interview-12 (ZBI-12) Scale Score
Short form of the Zarit Burden Interview-12 (ZBI-12) scale (12-items). The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Measured: 12 months
Caregiver Self-rated General Health Score
Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 self-rated general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.
Measured: 12 months
UCLA Loneliness Scale Score
UCLA loneliness scale (3-items). The scale score is calculated by summing each item to produce a total score between 3 and 9, with higher scores indicating worse outcome.
Measured: 12 months
Lubben Social Isolation Scale Score
Lubben Social isolation scale (6-items). The scale score is calculated by summing each item to produce a total score between 0 and 30, with lower scores indicating worse outcome.
Measured: 12 months
Caregiver Health Care Utilization
3-items measuring days of overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from self-report for past 12 months to self-report for past 6 months; scored as single items; with higher scores indicating worse outcome. Scores range from 0-180.
Measured: 12 months
Person With Dementia General Health Score as Reported by Caregiver
Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 caregiver-reported general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start5 Jun 2020
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Veronica Yank, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428112
- Sponsor's protocol ID
- 18-25814
- Other IDs
- 5R01AG057855-02, 3R01AG057855-02S1
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2020
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data to be shared will be individual participant data that underlie the results reported in published article(s), after deidentification (e.g., text, tables, figures, and appendices). The additional and related documents that will be available are study protocol and data dictionary. The data will become available beginning within 3 months of article publication and ending 5 years following article publication.The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).
Publications
Santoyo-Olsson J, Covinsky KE, Cheng J, Gallagher Thompson D, Yank V. Utilization of home- and community-based services among rural family caregivers of persons with dementia: the role of the area deprivation index. Front Public Health. 2025 Oct 14;13:1688161. doi: 10.3389/fpubh.2025.1688161. eCollection 2025.
PubMed 41164840Santoyo-Olsson J, Covinsky KE, Chesla CA, Lorig K, Gallagher-Thompson D, Cheng J, Luzanilla M, Macias Romo E, Aguayo Ramirez G, Karliner L, Yank V. Predictors of Psychological Distress Among Rural Family/Friend Caregivers of People Living With Dementia in the United States: Consequences of the COVID-19 Pandemic. J Gerontol B Psychol Sci Soc Sci. 2024 Feb 1;79(2):gbad164. doi: 10.1093/geronb/gbad164.
PubMed 37897201Santoyo-Olsson J, Lorig K, Romo EM, Luzanilla M, Ramirez GA, Cheng J, Chesla C, Covinsky KE, Karliner L, Thompson DG, Fahrenwald N, Yank V. Study protocol for a hybrid effectiveness-implementation trial of the Building Better Caregivers online workshop for rural family/friend caregivers of people living with dementia. Contemp Clin Trials. 2022 Oct;121:106903. doi: 10.1016/j.cct.2022.106903. Epub 2022 Aug 31.
PubMed 36057375
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT04428112
- Acronym / sponsor ID
- 18-25814
- Conditions
- Depression, Stress, Psychological, Self Efficacy, Loneliness, Social Isolation, Health Care Utilization
- Keywords
- Caregiver, Caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rural caregivers face challenges of geographic isolation and lower health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers.
Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia.
The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depressive symptoms. The investigators hypothesize that stress scores and depressive symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations.
If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Building Better Caregivers Workshop Group | Experimental | Behavioral: Building Better Caregivers WorkshopBuilding Better Caregivers Workshop is a 6-week online self-management and skills building workshop. Participants receive the online workshop as soon as possible after randomization. |
| Attention Control Group | Active comparator | Behavioral: Attention ControlParticipants will be offered the online workshop after the 12 month trial is completed if they so desire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Caring for person with dementia
- Able to read and write in English
- Able to access the internet
- Providing care for ≥ 10 hours per week
Key exclusion criteria (1 listed)
- Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)
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 |
|---|---|---|
| Building Better Caregivers WorkshopWorkshops consist of small group or about 20-25 persons. Two peer co-facilitators (caregiver themselves) will guide workshop activities. Participants will receive a workshop booklet. Each week, participants will log on at least 2-3 times for a total time of approximately two hours. Participants do not require "real time" attendance at pre-determined times. | Behavioural | Building Better Caregivers Workshop Group |
| Attention ControlParticipants will receive two brief 15-30 minutes phone calls by study staff, and will receive a handbook on dementia and caregiver resources while they wait for the workshop. | Behavioural | Attention Control Group |
Primary outcome
Personal Health Questionnaire Depression (PHQ-8) Scale Score
Time frame: 12 months
Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Visual Numeric Stress Scale
Time frame: 12 months
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
9 secondary outcomes
Personal Health Questionnaire Depression (PHQ-8) Scale Score
Time frame: 6 months
Visual Numeric Stress Scale Score
Time frame: 6 months
Short Caregiver Self-Efficacy Scale Score
Time frame: 12 months
Zarit Burden Interview-12 (ZBI-12) Scale Score
Time frame: 12 months
Caregiver Self-rated General Health Score
Time frame: 12 months
UCLA Loneliness Scale Score
Time frame: 12 months
Lubben Social Isolation Scale Score
Time frame: 12 months
Caregiver Health Care Utilization
Time frame: 12 months
Person With Dementia General Health Score as Reported by Caregiver
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41164840Santoyo-Olsson J, Covinsky KE, Cheng J, Gallagher Thompson D, Yank V. Utilization of home- and community-based services among rural family caregivers of persons with dementia: the role of the area deprivation index. Front Public Health. 2025 Oct 14;13:1688161. doi: 10.3389/fpubh.2025.1688161. eCollection 2025.
- Derived from this study: PubMed 37897201Santoyo-Olsson J, Covinsky KE, Chesla CA, Lorig K, Gallagher-Thompson D, Cheng J, Luzanilla M, Macias Romo E, Aguayo Ramirez G, Karliner L, Yank V. Predictors of Psychological Distress Among Rural Family/Friend Caregivers of People Living With Dementia in the United States: Consequences of the COVID-19 Pandemic. J Gerontol B Psychol Sci Soc Sci. 2024 Feb 1;79(2):gbad164. doi: 10.1093/geronb/gbad164.
- Derived from this study: PubMed 36057375Santoyo-Olsson J, Lorig K, Romo EM, Luzanilla M, Ramirez GA, Cheng J, Chesla C, Covinsky KE, Karliner L, Thompson DG, Fahrenwald N, Yank V. Study protocol for a hybrid effectiveness-implementation trial of the Building Better Caregivers online workshop for rural family/friend caregivers of people living with dementia. Contemp Clin Trials. 2022 Oct;121:106903. doi: 10.1016/j.cct.2022.106903. Epub 2022 Aug 31.
- Individual participant dataSharing planned: Yes. The data to be shared will be individual participant data that underlie the results reported in published article(s), after deidentification (e.g., text, tables, figures, and appendices). The additional and related documents that will be available are study protocol and data dictionary. The data will become available beginning within 3 months of article publication and ending 5 years following article publication.The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).
Related trials for Depression
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
RecruitingObservational study
Characterization and Treatment of Adolescent Depression
Depression
Active, not recruiting
Preventing Anxiety and Depression in Older Hispanics
Depression, Anxiety
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
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.
Veronica Yank, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Better Caregivers Workshop in people with Depression and Stress, Psychological, run by University of California, San Francisco 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 7 inclusion and 1 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 17 Jul 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 17 Jul 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?
Personal Health Questionnaire Depression (PHQ-8) Scale Score (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428112, which also lists 3 linked publications.
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 17 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.