The WeACT Program for Family Caregivers of People Living With Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
WeACT
BehavioralWeACT 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Acceptance and commitment therapy (ACT) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Enrollment rate
Enrollment rate will be defined as the number of individuals who consent and complete baseline divided by the number eligible and invited.
Time frame
During the recruitment period (up to approximately 6 months)2
Retention (post-intervention assessment completion)
Retention will be defined as the proportion of enrolled participants who complete the post-intervention assessment.
Time frame
Baseline through post-intervention (approximately 6-8 weeks)3
Core module completion (adherence)
Adherence will be defined as completion of the core modules (range 0-6 modules).
Time frame
During program participation (~6-8 weeks)Secondary outcomes
1
Acceptability of Intervention Measure
4-item acceptability rating (5-point Likert-type responses; 1 = completely disagree to 5 = completely agree).
Time frame
Post-intervention (~6-8 weeks)2
Intervention Appropriateness Measure
4-item appropriateness rating (5-point Likert-type responses; 1 = completely disagree to 5 = completely agree).
Time frame
Post-intervention (~6-8 weeks)3
Feasibility of Intervention Measure
4-item perceived feasibility rating (5-point Likert-type responses; 1 = completely disagree to 5 = completely agree).
Time frame
Post-intervention (~6-8 weeks)4
System Usability Scale (SUS)
10-item usability measure (5-point Likert); interpreted using common benchmarks (e.g., \~68 average; ≥70 acceptable).
Time frame
Post-intervention (approximately 6-8 weeks)Other outcomes
1
User experiences (Semi-structured individual interviews)
Individual interviews (\~40 minutes) will be conducted via videoconference to explore user experiences (e.g., perceived impact, usability/access, and suggestions for improvement).
Time frame
Post-intervention (approximately 6-8 weeks)2
In-app daily ACT skills practice use
Number of self-initiated, tailored ACT daily practice sections completed per participant (log-based).
Time frame
During program participation (~6-8 weeks)3
Participant Perceptions of Weekly Modules and Daily Practice Section
Separate additional questions about the online weekly modules and daily practice section will assess participants' perceptions of clarity, ease of use, visual design and layout, relevance, engagement, perceived usefulness, manageability, and overall satisfaction using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scale scores will be calculated.
Time frame
Post-intervention (approximately 6-8 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov