The WeACT Program for Family Caregivers of People Living With Dementia

NCT ID: NCT07342569

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2026-12-01

Brief 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. 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 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acceptance and commitment therapy (ACT) group

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.

Group Type: EXPERIMENTAL

WeACT

Intervention Type: BEHAVIORAL

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.

Interventions

WeACT

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Community-dwelling adults (aged 18 years or older) who have primary caregiving responsibilities for a relative diagnosed with dementia;

2. Present mild to moderate depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), with scores between 5 and 14; and

3. Have access to a web-enabled device (i.e., a smartphone, tablet, laptop, or desktop) with internet access

Exclusion Criteria

1. Cognitive, physical, or sensory impairments, or language barriers (non-English communicator) that might impede study participation;

2. Present moderately severe to severe depressive symptoms, defined as PHQ-9 scores between 15 and 27;

3. Have previously participated in a research study that involved an ACT program;

4. Have suicidal intent or a suicide attempt within the past six months;

5. Are currently participating in another caregiver study; or

6. Have experienced more than three hospitalizations (of either the family caregiver or the relative with dementia) within the past year.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Areum Han

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areum Han

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Countries

United States

Central Contacts

Areum Han, PhD

Role: CONTACT

areumhan@usf.edu

813-396-0524

Jeremy Jenkins, MS

Role: CONTACT

jeremyjenkins@usf.edu

813-396-0524

Facility Contacts

Areum Han, PhD

Role: primary

areumhan@usf.edu

813-396-0524

Jeremy Jenkins, MS

Role: backup

jeremyjenkins@usf.edu

813-396-0524

Other Identifiers

7R21AG085254-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY009455

Identifier Type: -

Identifier Source: org_study_id