An interventional study of Building Better Caregivers Workshop and Attention Control in Depression, Stress, Psychological and Self Efficacy, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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).
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 418 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Building Better Caregivers Workshop
Participants will be offered the online workshop after the 12 month trial is completed if they so desire.
Behavioral: Attention Control
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.
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.
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.
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
| Milestone | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Started | 304 | 114 |
| Group delivery begins = modified intention to treat population | 300 | 109 |
| 1.5 month follow-up | 266 | 103 |
| 6-month follow-up | 261 | 99 |
| Completed | 196 | 69 |
| Not completed | 108 | 45 |
| Withdrew: Administratively removed prior to group delivery: unable to verify identify, duplicate, plwd death | 4 | 5 |
| Withdrew: Planned study completion at 6-months. 2 final cohorts initiated with known follow up of 6 months. | 68 | 29 |
| Withdrew: Withdrawal by subject | 9 | 4 |
| Withdrew: Lost to follow-up | 27 | 7 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Personal Health Questionnaire Depression (PHQ-8) Scale Score | 5.6 ± 4.1 | 5.8 ± 4.4 |
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
| score on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Visual Numeric Stress Scale | 5.9 ± 2.2 | 6.0 ± 2.1 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Personal Health Questionnaire Depression (PHQ-8) Scale Score | 5.7 ± 4.6 | 7.1 ± 5.4 |
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Visual Numeric Stress Scale Score | 6.0 ± 2.2 | 5.9 ± 2.2 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Short Caregiver Self-Efficacy Scale Score | 5.4 ± 2.0 | 5.1 ± 1.6 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Zarit Burden Interview-12 (ZBI-12) Scale Score | 21.9 ± 9.0 | 23.4 ± 7.3 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Caregiver Self-rated General Health Score | 2.6 ± 0.9 | 2.7 ± 0.9 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| UCLA Loneliness Scale Score | 5.9 ± 2.0 | 5.4 ± 1.9 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Lubben Social Isolation Scale Score | 13.1 ± 5.7 | 13.8 ± 5.1 |
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.
| days | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Caregiver Health Care Utilization | 0.30 ± 1.3 | 0.84 ± 3.1 |
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.
| units on a scale | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| Person With Dementia General Health Score as Reported by Caregiver | 3.8 ± 1.0 | 3.8 ± 1.0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Building Better Caregivers Workshop Group | 0/304 (0%) | 0/304 (0%) | 0/304 (0%) |
| Attention Control Group | 1/114 (0.9%) | 1/114 (0.9%) | 0/114 (0%) |
| Event | Building Better Caregivers Workshop Group | Attention Control Group |
|---|---|---|
| natural disasterGeneral disorders | 0/304 | 1/114 |
| Age, Continuous(years) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| Mean | 61.79 ± 11.47 | 63.53 ± 10.57 | 62.26 ± 11.24 |
| Sex/Gender, Customized(Participants) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| Sex — Female | 258 | 94 | 352 |
| Sex — Male | 42 | 20 | 62 |
| Sex — Prefers not to identify | 4 | 0 | 4 |
| Race/Ethnicity, Customized(Participants) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| White | 263 | 96 | 359 |
| Black/African American | 14 | 4 | 18 |
| Hispanic/Latino | 11 | 6 | 17 |
| American Indian/Native American/Alaska Native | 4 | 4 | 8 |
| Asian/Asian American | 0 | 1 | 1 |
| Native Hawaiian/Other Pacific Islander | 1 | 0 | 1 |
| More than one race | 3 | 0 | 3 |
| Other | 3 | 1 | 4 |
| Unknown or not reported | 5 | 2 | 7 |
| Region of Enrollment(participants) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| United States | 304 | 114 | 418 |
| PHQ-8(units on a scale) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| Mean | 5.3 ± 4.4 | 5.9 ± 4.7 | 5.5 ± 4.5 |
| Stress(units on a scale) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| Mean | 6.5 ± 1.8 | 6.8 ± 1.8 | 6.6 ± 1.8 |
| Caregiver Self-Efficacy(units on a scale) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| Mean | 5.2 ± 1.8 | 5.1 ± 1.8 | 5.2 ± 1.8 |
| Zarit Care Burden(units on a scale) | Building Better Caregivers Workshop Group | Attention Control Group | Total |
|---|---|---|---|
| Mean | 22.9 ± 8.6 | 22.6 ± 7.7 | 22.8 ± 8.3 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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).
Supporting information: Study protocol
Time frame: The data will become available beginning within 3 months of article publication and ending 5 years following article publication.
Access criteria: 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).
Ran from Jun 2020 to primary completion in Oct 2023, 40 months.
Results were first posted in Jul 2025, 1 year 9 months after primary completion.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 40 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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