DepressionNCT07342569
The WeACT Program for Family Caregivers of People Living With Dementia
A study testing WeACT in people with Depression and Caregivers, run by University of South Florida at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Caregivers, Dementia
- What is being tested?
- WeACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family caregivers of people living with dementia will be eligible to participate if they meet all of the following criteria:
- Are community-dwelling adults aged 18 years or older who have primary caregiving responsibilities for a relative diagnosed with dementia;
- Present mild to moderately severe depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), with scores between 5 and 19; and
- Have access to a web-enabled device, such as a smartphone, tablet, laptop, or desktop computer, with internet access.
Who cannot join
- Family caregivers of people living with dementia will be excluded if they meet any of the following criteria:
- Have cognitive, physical, or sensory impairments, or are unable to complete study procedures in English, that may impede study participation;
- Present severe depressive symptoms, defined as PHQ-9 scores of 20 or higher;
- Report having thoughts of harming themselves or attempting suicide within the past six months;
- Have previously participated in a research study involving an ACT program;
- Are currently participating in another caregiver intervention study; or
- Have experienced more than three hospitalizations of either the family caregiver or the relative with dementia within the past year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Areum Han, PhD, 813-396-0524, areumhan@usf.edu
Jeremy Jenkins, MS, 813-396-0524, jeremyjenkins@usf.edu
About this study
The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most.
The main questions this study aims to answer are:
Read more
- Can caregivers complete WeACT as planned?
- Do caregivers show improvements in mental health and coping after using WeACT?
- What are caregivers' experiences with the program, and what suggestions do they have to improve it?
Participants will:
- Complete six self-paced weekly online modules and use the daily practice section during the program.
- Complete online questionnaires before starting and after completing the program.
- Take part in one online interview about their experience.
Read the detailed description
Family caregivers of people living with dementia often experience psychological distress (such as depressive symptoms and stress) and face practical barriers to accessing support. This study will evaluate WeACT, a research-developed, self-paced, web-based acceptance and commitment therapy (ACT) skills program designed to support caregivers' mental health outcomes in a scalable format. This is a one-group, pretest-posttest mixed-methods pilot study conducted fully online. All enrolled participants will receive access to the WeACT program. The study will assess feasibility and user experience and will explore pre-to-post changes in caregiver mental health outcomes and ACT-related processes. WeACT includes six self-paced weekly ACT modules and a tailored daily practice section. Each weekly module includes ACT skills training materials. The daily practice section provides brief, in-the-moment ACT skill coaching based on participants' current self-ratings. Recruitment will occur by distributing a study flyer across the United States. Interested individuals will contact the study team and complete an online eligibility screening survey. Eligible individuals will complete electronic informed consent and then complete pretest questionnaires online. After completing baseline procedures, participants will receive program access and study-specific login credentials. Participants will be encouraged to complete one module per week and to use the daily practice section regularly during the intervention period. After completing the program modules, participants will complete posttest questionnaires online and participate in a one-time individual interview. Interviews will be conducted and recorded using the HIPAA-compliant version of Microsoft Teams. Feasibility will be evaluated using recruitment, retention, and adherence indicators and by documenting reasons for ineligibility and dropout. The program will also capture engagement and in-program response data. Pretest and posttest questionnaires will be used to explore changes in caregiver mental health outcomes and ACT-related processes and to assess perceived feasibility, acceptability, appropriateness, and usability at posttest. Qualitative interviews will be used to understand participant experiences and identify recommendations to refine the program and study procedures. Analyses will focus on feasibility and descriptive characterization of engagement. Pre-to-post changes will be explored using paired statistical tests as appropriate. Daily practice data will be explored using multilevel modeling to estimate average change and individual variability over time. Interview data will be analyzed using thematic analysis to summarize common experiences and improvement suggestions. All data will be collected electronically using university-approved secure platforms (Qualtrics, the WeACT program hosted on the secure USF Microsoft Azure environment, and HIPAA-compliant Microsoft Teams). WeACT is not publicly available and is accessible only to enrolled participants. Participants will use study-specific login credentials. Identifying information will be collected only as needed for study operations (e.g., communication and compensation) and stored separately from research data. Study data will be stored in secure, access-controlled USF systems (including USF Box), with access restricted to authorized study personnel. Only de-identified, aggregate results will be used for dissemination.
- Conditions
- Depression, Caregivers, Dementia
- Being tested
- WeACT
- Keywords
- acceptance and commitment therapy, Internet-Based Intervention, caregivers, dementia, depressive symptoms, feasibility, usability, web-based intervention, mixed methods, Pilot Study
- Medical subject headings
- Depression, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeACTBehavioural
WeACT includes six self-paced weekly ACT modules and a tailored daily practice component. Each weekly module includes ACT skills training materials. The daily practice section provides brief, in-the-moment ACT skill coaching based on participants' current self-ratings.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | The ACT group will complete the WeACT program, a self-paced, web-based ACT program that includes six weekly online modules and a daily practice section. Receives: Behavioral: WeACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Enrollment rate will be defined as the number of individuals who consent and complete baseline divided by the number eligible and invited.
Measured: During the recruitment period (up to approximately 6 months)
Retention (post-intervention assessment completion)
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment.
Measured: Baseline through post-intervention (approximately 6-8 weeks)
Core module completion (adherence)
Adherence will be defined as completion of the core modules (range 0-6 modules).
Measured: During program participation (~6-8 weeks)
Secondary outcomes (15)
Acceptability of Intervention Measure
4-item acceptability rating (5-point Likert-type responses; 1 = completely disagree to 5 = completely agree).
Measured: Post-intervention (~6-8 weeks)
Intervention Appropriateness Measure
4-item appropriateness rating (5-point Likert-type responses; 1 = completely disagree to 5 = completely agree).
Measured: Post-intervention (~6-8 weeks)
Feasibility of Intervention Measure
4-item perceived feasibility rating (5-point Likert-type responses; 1 = completely disagree to 5 = completely agree).
Measured: Post-intervention (~6-8 weeks)
System Usability Scale (SUS)
10-item usability measure (5-point Likert); interpreted using common benchmarks (e.g., ~68 average; ≥70 acceptable).
Measured: Post-intervention (approximately 6-8 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention
PHQ-9 is a nine-item self-report questionnaire assessing depressive symptoms over the past two weeks, rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Generalized Anxiety Disorder-7 (GAD-7) scores from baseline to post-intervention
GAD-7 is a seven-item self-report questionnaire assessing anxiety symptoms over the past two weeks, rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores reflecting greater anxiety symptoms.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Perceived Stress Scale-10 (PSS-10) scores from baseline to post-intervention
PSS-10 is a 10-item questionnaire assessing stress on a scale of 0 to 4. Scores range from 0 to 40. Higher scores indicate greater stress.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF)- Psychological Health Subscale scores from baseline to post-intervention
WHOQOL-BREF-Psychological Health Subscale has 6 items measuring psychological quality of life on a scale of 1 to 5. The total scores range from 6 to 30. Higher scores denote a higher quality of life in terms of psychological health.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Zarit Burden Interview (ZBI) scores from baseline to post-intervention
ZBI is a 12-item self-report questionnaire assessing caregiver burden on a scale of 0 to 4. The total scores range from 0 to 48. Higher scores indicate higher burden levels.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Marwit-Meuser Caregiver Grief Inventory-Brief Form (MM-CGI-BF) scores from baseline to post-intervention
MM-CGI-BF is a six-item self-report questionnaire that assesses pre-death grief in caregivers of people with dementia, rated on a scale from 1 to 5. Scores range from 6 to 30, with higher scores indicating greater grief.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Caregiver Guilt Questionnaire (CGQ) scores from baseline to post-intervention
CGQ is a 22-item self-report measure that assesses feelings of guilt in caregivers, rated on a scale from 0 to 4. Scores range from 0 to 88, with higher scores indicating greater levels of guilt.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Brief Experiential Avoidance Questionnaire (BEAQ) scores from baseline to post-intervention
BEAQ is a15-item self-report measure of experiential avoidance on a scale of 1 to 6. Total scores range from 15 to 90, with higher scores indicating greater experiential avoidance.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Cognitive Fusion Questionnaire-7 (CFQ-7) scores from baseline to post-intervention
CFQ-7 is a 7-item self-report questionnaire measuring cognitive fusion on a scale of 1 to 7. The total scores range from 7 to 49, and higher scores indicate a higher degree of cognitive fusion.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Engaged Living Scale-9 (ELS-9) scores from baseline to post-intervention
ELS-9 is a 9-item self-assessment instrument that measures clarity and engagement with personal values and life fulfillment on a scale of 1 to 5. The total scores range from 9 to 45, and higher scores indicate increased clarity and engagement with personal values.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Change in Multidimensional Psychological Flexibility Inventory-24 (MPFI-24) scores from baseline to post-intervention
MPFI-24 is a 24-item self-report measure of multidimensional psychological flexibility and inflexibility processes on a scale of 1 to 6. Higher subscale or composite scores indicate greater psychological flexibility or inflexibility.
Measured: Baseline to post-intervention (approximately 6-8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start23 Sep 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Areum Han, University of South Florida
- Investigators
- Areum Han, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342569
- Sponsor's protocol ID
- STUDY009455
- Other IDs
- 7R21AG085254-02
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WeACT Program for Family Caregivers of People Living With Dementia
- ClinicalTrials.gov ID
- NCT07342569
- Acronym / sponsor ID
- STUDY009455
- Conditions
- Depression, Caregivers, Dementia
- Keywords
- acceptance and commitment therapy, Internet-Based Intervention, caregivers, dementia, depressive symptoms, feasibility, usability, web-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most.
The main questions this study aims to answer are:
- Can caregivers complete WeACT as planned?
- Do caregivers show improvements in mental health and coping after using WeACT?
- What are caregivers' experiences with the program, and what suggestions do they have to improve it?
Participants will:
- Complete six self-paced weekly online modules and use the daily practice section during the program.
- Complete online questionnaires before starting and after completing the program.
- Take part in one online interview about their experience.
Detailed description
Family caregivers of people living with dementia often experience psychological distress (such as depressive symptoms and stress) and face practical barriers to accessing support. This study will evaluate WeACT, a research-developed, self-paced, web-based acceptance and commitment therapy (ACT) skills program designed to support caregivers' mental health outcomes in a scalable format. This is a one-group, pretest-posttest mixed-methods pilot study conducted fully online. All enrolled participants will receive access to the WeACT program. The study will assess feasibility and user experience and will explore pre-to-post changes in caregiver mental health outcomes and ACT-related processes. WeACT includes six self-paced weekly ACT modules and a tailored daily practice section. Each weekly module includes ACT skills training materials. The daily practice section provides brief, in-the-moment ACT skill coaching based on participants' current self-ratings. Recruitment will occur by distributing a study flyer across the United States. Interested individuals will contact the study team and complete an online eligibility screening survey. Eligible individuals will complete electronic informed consent and then complete pretest questionnaires online. After completing baseline procedures, participants will receive program access and study-specific login credentials. Participants will be encouraged to complete one module per week and to use the daily practice section regularly during the intervention period. After completing the program modules, participants will complete posttest questionnaires online and participate in a one-time individual interview. Interviews will be conducted and recorded using the HIPAA-compliant version of Microsoft Teams. Feasibility will be evaluated using recruitment, retention, and adherence indicators and by documenting reasons for ineligibility and dropout. The program will also capture engagement and in-program response data. Pretest and posttest questionnaires will be used to explore changes in caregiver mental health outcomes and ACT-related processes and to assess perceived feasibility, acceptability, appropriateness, and usability at posttest. Qualitative interviews will be used to understand participant experiences and identify recommendations to refine the program and study procedures. Analyses will focus on feasibility and descriptive characterization of engagement. Pre-to-post changes will be explored using paired statistical tests as appropriate. Daily practice data will be explored using multilevel modeling to estimate average change and individual variability over time. Interview data will be analyzed using thematic analysis to summarize common experiences and improvement suggestions. All data will be collected electronically using university-approved secure platforms (Qualtrics, the WeACT program hosted on the secure USF Microsoft Azure environment, and HIPAA-compliant Microsoft Teams). WeACT is not publicly available and is accessible only to enrolled participants. Participants will use study-specific login credentials. Identifying information will be collected only as needed for study operations (e.g., communication and compensation) and stored separately from research data. Study data will be stored in secure, access-controlled USF systems (including USF Box), with access restricted to authorized study personnel. Only de-identified, aggregate results will be used for dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy (ACT) group | Experimental | Behavioral: WeACTThe ACT group will complete the WeACT program, a self-paced, web-based ACT program that includes six weekly online modules and a daily practice section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Family caregivers of people living with dementia will be eligible to participate if they meet all of the following criteria:
- Are community-dwelling adults aged 18 years or older who have primary caregiving responsibilities for a relative diagnosed with dementia;
- Present mild to moderately severe depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), with scores between 5 and 19; and
- Have access to a web-enabled device, such as a smartphone, tablet, laptop, or desktop computer, with internet access.
Key exclusion criteria (7 listed)
- Family caregivers of people living with dementia will be excluded if they meet any of the following criteria:
- Have cognitive, physical, or sensory impairments, or are unable to complete study procedures in English, that may impede study participation;
- Present severe depressive symptoms, defined as PHQ-9 scores of 20 or higher;
- Report having thoughts of harming themselves or attempting suicide within the past six months;
- Have previously participated in a research study involving an ACT program;
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 |
|---|---|---|
| WeACTWeACT includes six self-paced weekly ACT modules and a tailored daily practice component. Each weekly module includes ACT skills training materials. The daily practice section provides brief, in-the-moment ACT skill coaching based on participants' current self-ratings. | Behavioural | Acceptance and commitment therapy (ACT) group |
Primary outcome
Enrollment rate
Time frame: During the recruitment period (up to approximately 6 months)
Enrollment rate will be defined as the number of individuals who consent and complete baseline divided by the number eligible and invited.
Retention (post-intervention assessment completion)
Time frame: Baseline through post-intervention (approximately 6-8 weeks)
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment.
Core module completion (adherence)
Time frame: During program participation (~6-8 weeks)
Adherence will be defined as completion of the core modules (range 0-6 modules).
15 secondary outcomes
Acceptability of Intervention Measure
Time frame: Post-intervention (~6-8 weeks)
Intervention Appropriateness Measure
Time frame: Post-intervention (~6-8 weeks)
Feasibility of Intervention Measure
Time frame: Post-intervention (~6-8 weeks)
System Usability Scale (SUS)
Time frame: Post-intervention (approximately 6-8 weeks)
Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Generalized Anxiety Disorder-7 (GAD-7) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Perceived Stress Scale-10 (PSS-10) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF)- Psychological Health Subscale scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Zarit Burden Interview (ZBI) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Marwit-Meuser Caregiver Grief Inventory-Brief Form (MM-CGI-BF) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Caregiver Guilt Questionnaire (CGQ) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Brief Experiential Avoidance Questionnaire (BEAQ) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Cognitive Fusion Questionnaire-7 (CFQ-7) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Engaged Living Scale-9 (ELS-9) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Change in Multidimensional Psychological Flexibility Inventory-24 (MPFI-24) scores from baseline to post-intervention
Time frame: Baseline to post-intervention (approximately 6-8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Areum Han principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeACT in people with Depression and Caregivers, run by University of South Florida 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Areum Han, PhD (813-396-0524, areumhan@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: During the recruitment period (up to approximately 6 months)). The study lists 3 primary outcomes in all. 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 27 Oct 2026.