The WeACT Program for Family Caregivers of People Living With Dementia

N/ANot Yet RecruitingNCT07342569

University of South Florida40 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria Family caregivers of people living with dementia will be eligible to participate if they meet all of the following criteria: 1. Are community-dwelling adults aged 18 years or older who have primary caregiving responsibilities for a relative diagnosed with dementia; 2. Present mild to moderately severe depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), with scores between 5 and 19; and 3. Have access to a web-enabled device, such as a smartphone, tablet, laptop, or desktop computer, with internet access. Exclusion criteria Family caregivers of people living with dementia will be excluded if they meet any of the following criteria: 1. Have cognitive, physical, or sensory impairments, or are unable to complete study procedures in English, that may impede study participation; 2. Present severe depressive symptoms, defined as PHQ-9 scores of 20 or higher; 3. Report having thoughts of harming themselves or attempting suicide within the past six months; 4. Have previously participated in a research study involving an ACT program; 5. Are currently participating in another caregiver intervention study; or 6. Have experienced more than three hospitalizations of either the family caregiver or the relative with dementia within the past year.

Outcomes

Primary Outcomes

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)

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)

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

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)

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)

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)

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)

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.