The WeACT Program for Family Caregivers of People Living With Dementia

NCT07342569 | Not Yet Recruiting

• 2 other identifiers: STUDY0094557R21AG085254-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers; Dementia; Depression

Keywords

acceptance and commitment therapy; Internet-Based Intervention; caregivers; dementia; depressive symptoms; feasibility; usability; web-based intervention; mixed methods; Pilot Study

Outcome Measures

Primary Outcomes (3)

• Enrollment rate

  Enrollment rate will be defined as the number of individuals who consent and complete baseline divided by the number eligible and invited.

  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.

  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).

  During program participation (~6-8 weeks)

Secondary Outcomes (14)

• Acceptability of Intervention Measure

  Post-intervention (~6-8 weeks)

• Intervention Appropriateness Measure

  Post-intervention (~6-8 weeks)

• Feasibility of Intervention Measure

  Post-intervention (~6-8 weeks)

• System Usability Scale (SUS)

  Post-intervention (approximately 6-8 weeks)

• Change in Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention

  Baseline to post-intervention (approximately 6-8 weeks)

Other Outcomes (2)

• User experiences (Semi-structured individual interviews)

  Post-intervention (approximately 6-8 weeks)

• In-app daily ACT skills practice use

  During program participation (~6-8 weeks)

Study Arms (1)

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.

Behavioral: WeACT

Interventions

WeACT 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.

Acceptance and commitment therapy (ACT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling adults (aged 18 years or older) who have primary caregiving responsibilities for a relative diagnosed with dementia;
• Present mild to moderate depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), with scores between 5 and 14; and
• Have access to a web-enabled device (i.e., a smartphone, tablet, laptop, or desktop) with internet access

You may not qualify if:

• Cognitive, physical, or sensory impairments, or language barriers (non-English communicator) that might impede study participation;
• Present moderately severe to severe depressive symptoms, defined as PHQ-9 scores between 15 and 27;
• Have previously participated in a research study that involved an ACT program;
• Have suicidal intent or a suicide attempt within the past six months;
• Are currently participating in another caregiver study; or
• Have experienced more than three hospitalizations (of either the family caregiver or the relative with dementia) within the past year.

Sponsors & Collaborators

• University of South Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Depression; Dementia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Areum Han

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Areum Han, PhD

CONTACT

813-396-0524; areumhan@usf.edu

Jeremy Jenkins, MS

CONTACT

813-396-0524; jeremyjenkins@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)