ACT for Dementia Caregivers: Evaluating Psychological Flexibility as the Mechanism to Improve Psychological Distress
Online Self-guided ACT for Dementia Caregivers: Evaluating Psychological Flexibility as the Mechanism to Improve Psychological Distress
Over 55 million people worldwide have dementia, and in the United States, 80% of people with dementia are cared for at home by family. While family caregivers report positive aspects of their role, many report depressive and anxiety symptoms, and global distress. There is vast heterogeneity in caregivers' experiences, dependent on biopsychosocial risk/contextual factors, and secondary challenges (financial concerns, work disturbances, etc.). While an array of empirically validated interventions can support dementia caregivers, interventions utilizing a transdiagnostic approach can yield improvements in comorbid symptomatology by addressing common underlying mechanisms of chronic or acute conditions, and mechanisms that promote living well with stress.
Acceptance and Commitment Therapy (ACT) is a modern ("third wave") Cognitive Behavioral Therapy (CBT) that addresses clinically significant, or subclinical levels of anxiety, depression, and a myriad of other conditions. The transdiagnostic mechanism in ACT involves increasing psychological flexibility, by changing the impact of negative thoughts and feelings, without having to change the frequency or form of their occurrence. ACT teaches individuals how to engage with painful/stressful experiences and respond with behaviors aligned with their personal values. Across 20 meta-analyses (n=12,477) of ACT clinical trials, ACT is efficacious in improving depression, anxiety, distress, and more. In dementia caregivers, therapist-guided ACT has also yielded improvements in various aspects of psychological distress.
Despite the evidence for ACT improving dementia caregivers' mental health, therapist-delivered interventions are more costly, less convenient, and less "scalable" (i.e. reaching fewer individuals). Online self-guided therapies can be equally effective as face-to-face therapy and are effective for caregivers. In non-caregivers, ACT has been adapted to online, self-guided delivery, demonstrating effective therapeutic results. The investigators' preliminary (Stage I and II) studies provide evidence that ACT is feasible and acceptable in an online, self-guided program tailored to dementia caregivers, and have identified preliminary efficacy in improving the proposed mechanism of change, psychological flexibility, and outcomes of caregiver depression. There is, however, a substantial need to understand if/how psychological flexibility and engagement with ACT for Caregivers work mechanistically to reduce psychological distress for users (with distress defined by the DASS-21 as symptoms of depression, anxiety, and stress). This proposal is responding to the EMBRACE call for mechanism-focused dementia care and caregiver support intervention development, targeting the level of the caregiver. Guided by the Checklist for Investigating Mechanisms in Behavior-change Research (CLIMBR), this Stage II (N=120) waitlist randomized control trial (RCT) will:
- Determine the efficacy of an online, self-guided ACT for Caregivers program for improving dementia caregiver psychological distress. The investigators hypothesize that treatment-to-waitlist condition will be associated with reductions in psychological distress over time, pre-to-post intervention, where those in the treatment group will show greater improvements in distress compared to those in the waitlist condition.
- Determine if and how treatment effects explain changes in psychological flexibility and how changes to psychological flexibility account for changes in distress. The investigators hypothesize that caregivers in the treatment group will show improvements in psychological flexibility, above and beyond, those in the control group. Further, the investigators hypothesize that these changes to psychological flexibility will account for changes in distress.
- Determine if and how user adherence to the program at time 2 (i.e., number of online sessions completed) is associated with the proposed mechanism, psychological flexibility (at time 3). The investigators hypothesize that, within the treatment group, greater adherence to ACT modules will be associated with greater psychological flexibility and greater improvements in distress.
With this Stage II study, the investigators examine if the proposed mechanism of change in ACT for Caregivers -- psychological flexibility -- influences changes in caregivers' distress. The investigators also explore how user adherence to the program is associated with changes in both the mediator and the outcome. Gathering evidence on the mechanism of change and intervention adherence is a necessary step in establishing ACT for Caregivers as an empirically validated intervention for dementia caregivers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design of the current study:
The proposed study has several design aspects that should be identified and justified. It is a waitlist randomized controlled trial, allowing us a rigorous experimental design for between-person comparisons and robust assessments of mediation between treatment (Tx) and waitlist control (W), while also allowing all participants to get the treatment, and facilitating a larger sample size for within person analyses. See Figure 3 for the timing and delivery of the study assessments.
Participants Power analysis: Using RStudio, the investigators stimulated models using the lme4 package and mediation package. Based on pilot data, the investigators assumed a medium effect across all variables (i.e., X --> M, X--> Y, and M --> Y) and a strong intraclass correlation (ICC = .6). The investigators ran 1000 simulations and found that using a sample size of 120 participants (60 Tx, 60 in waitlist), the investigators were able to identify significant average causal mediation effect, significant average direct effect, a significant total effect, and that the proportion mediated was significant (all ps < .05). The estimated proportion mediated was approximately 25% (95% CI: [10%,57%]), suggesting the ability to identify meaningful indirect pathways from X to Y via M. These results indicate that a sample size of 120 participants provides adequate power for the mediation analyses. Given that the mediation model represents the most complex analysis in the study and accounts for individual pathways, this sample size will be sufficient to power the direct between- and within-person analyses outlined in both Aim 1 and Aim 2. Based on the pilot study where a 27.7% attrition rate was observed between the first and second timepoints, the investigators will aim to recruit 153 individuals into the study to arrive at the desired sample size of 120.
Recruitment: Family caregivers will be recruited through IRB-approved materials. The investigators will utilize the recruitment methods deemed most effective in the prior Stage I and II studies. Of note, the prior Stage II study recruited 90+ participants across nine months in 2023. The investigators will advertise via 1) the Alzheimer's Association's TrialMatch program, 2) social media and print/online stories distributed by Utah State University, 3) health fairs and events such as the Walk to End Alzheimer's, and 4) existing listservs of community partners. These partners include Utah's Alzheimer's Disease and Related Dementia Coordinating Council (Utah Department of Health and Human Services), and USU's Institute for Disability Research, Policy, and Practice. New approaches for the current study will include accessing the research registry of USU's Alzheimer's Disease and Dementia Research Center, and using the newly-established USU Dementia Caregiver Clinic, which brings in an estimated 80 caregivers per year. The investigators also will utilize the Participant Manager's time to actively recruit out of state to increase geographic and ethnic/racial heterogeneity. The investigators will request that the study opportunity be distributed via the 15 newsletters representing NIA supported ADRC's. With IRB approval, the investigators can request to access the Participant Resource Pool Michigan Center for Urban African American Aging Research (MCUAAAR).
Retention: Participants will receive weekly reminder emails to complete a session, on a day of their choosing. If a participant has lapsed in engagement for two weeks, they will receive a reminder phone call. If attrition occurs, the data from any of the assessments or responses in treatment sessions attended are still useful; as described in the analysis section, an intent to treat analytic approach will be used.
ACT for Caregivers Intervention: The ACT for Caregivers online, self-guided intervention is intended to improve psychological flexibility (via learning to be more open, aware, and engaged), and to improve psychological distress. Participants access 6 sessions (each corresponding to one or more tenets of psychological flexibility), which they work through in order, asynchronously at their own pace, at home. Participants are encouraged (but not mandated) to complete one session per a week over six weeks, with sessions taking 20-40 minutes to complete.
Analyses:
An 'intent to treat' approach will be employed for all participants in the study. Analyses will be completed using Stata 18 (data cleaning) and R 4.0.0 or higher (lme4, nlme). A linear mixed-model will be used, where measurement occasions (Level 1) are nested within individuals (Level 2); treatment condition will be a Level 2 predictor that tests differences between the treatment and waitlist groups from T1 to T3. As observations (Level 1) are nested within individuals' (Level 2) over time, the investigators will employ mediation analyses within a mixed modeling framework. As an RCT examining psychological flexibility (putative mediator = M) as a mechanism underlying the effects of the ACT intervention (intervention = X) on reductions in caregiver psychological distress (outcome = Y), the investigators will conduct the following analyses, consistent with the Checklist for Investigating Mechanisms in Behavior-change Research (CLIMBR).
To assess aim 1, Model 1 will be used to investigate whether participants assigned to treatment with the ACT intervention exhibit decreased psychological distress relative to wait-list control participants, establishing the CLIMBR X --> Y path. To assess aim 2, Model 2 will extend Model 1 to include psychological flexibility as a mediator (M), to evaluate the CLIMBR X --> M and X --> M --> Y linkages articulating the extent to which ACT intervention-related changes in distress are mediated by (increased) psychological flexibility.
Mediation with be formally evaluated by percent reduction in the X --> Y association, tests of indirect effects, and computation of mediator effect sizes in RCTs. Supplemental analyses will consider the subcomponents of psychological flexibility, open, aware, and engaged, to explore the specific dimension(s) driving ACT-related change in psychological distress. Further, chi-square tests of nested model comparisons, evaluating model fit when constraining the magnitude of psychological flexibility effects to be equal, will be employed to determine differences in the magnitude of psychological flexibility components as mediating mechanisms. The investigators will also consider false discovery rates to evaluate potential spurious associations.
To assess aim 3, the investigators will investigate the role of program adherence in associations between psychological flexibility and caregiver psychological distress. The investigators will regress changes in T1 --> T2 and T1 --> T3 psychological flexibility on the number of sessions completed at T2, the operant index of adherence (# sessions completed 75 percent or more), to determine any modulation of effect by adherence. All item-level missingness will be treated using full information maximum likelihood (FIML).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth B. Fauth, PhD
- Phone Number: 435-797-1989
- Email: beth.fauth@usu.edu
Study Contact Backup
- Name: Heather H Kelley, PhD
- Email: heather.kelley@usu.edu
Study Locations
-
-
Utah
-
Logan, Utah, United States, 84322
- Recruiting
- Utah State University
-
Contact:
- Lindy Stant, B.S.
- Phone Number: 435-797-2905
- Email: lindy.stant@usu.edu
-
Principal Investigator:
- Elizabeth B Fauth, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Family caregiver to a person with dementia or with significant memory loss that impacts their everyday life
- Distressed from their caregiving role as measured by a score of 4+ on a single item "How distressed are you by caring for your family member?" (1 not at all to 10 extremely).
- Interested in taking part in an online self-guided six-session program with multiple assessments
- Able to read/write in English
- Have access to a computer/smartphone/tablet with internet.
- Live in the United States
Exclusion:
- No additional exclusion criteria beyond if participants do not meet one or more of the inclusion criteria.
- Have a phone number from a land-line or cellular carrier. This latter requirement is to reduce fraudulent participants, who in prior studies all provided IP-based numbers (IP-based numbers are identifiable via free online software). Of note, cohabiting with the care receiver is NOT a requirement, as distress can occur in non-cohabiting care dyads.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
The treatment group will immediately receive access to the intervention following completion of the baseline survey. |
ACT for Caregivers is a self-guided digital mental health intervention intended to improve psychological flexibility (via learning to be more open, aware, and engaged), and to improve psychological distress. Participants access 6 sessions (each corresponding to one or more tenets of psychological flexibility), which they work through in order, asynchronously at their own pace, at home. Participants are encouraged (but not mandated) to complete one session per a week over six weeks, with sessions taking 20-40 minutes to complete. |
|
Experimental: Waitlist Group
This group will not receive the intervention until 12 weeks post baseline |
ACT for Caregivers is a self-guided digital mental health intervention intended to improve psychological flexibility (via learning to be more open, aware, and engaged), and to improve psychological distress. Participants access 6 sessions (each corresponding to one or more tenets of psychological flexibility), which they work through in order, asynchronously at their own pace, at home. Participants are encouraged (but not mandated) to complete one session per a week over six weeks, with sessions taking 20-40 minutes to complete. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: The DASS-21 will be assessed at baseline, 6-week posttest, and 12-week follow-up.
|
Depression, Anxiety, and Stress Scale (DASS-21) will be used to assess caregiver's overall psychological distress |
The DASS-21 will be assessed at baseline, 6-week posttest, and 12-week follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zarit Burden Interview-6 (ZBI-6)
Time Frame: The ZBI-6 will be completed at baseline, 6-week posttest, and 12-week follow-up.
|
The Zarit Burden Interview-6 (ZBI-6) is a 6-item scale designed to assess perceived caregiver burden and strain associated with providing care. Items assess the impact of caregiving on areas such as personal time, relationships, health, and emotional well-being. Responses range from 0 (never) to 4 (nearly always), with higher scores indicating greater caregiver burden |
The ZBI-6 will be completed at baseline, 6-week posttest, and 12-week follow-up.
|
|
Positive Aspects of Caregiving Scale-6 (PACS-6)
Time Frame: The PACS-6 will be completed at baseline, 6-week posttest, and 12-week follow-up.
|
The Positive Aspects of Caregiving Scale-6 (PACS-6) is a 6-item scale designed to assess positive perceptions and benefits associated with the caregiving experience, such as feeling useful, appreciated, needed, and more confident. Responses range from 1 (disagree a lot) to 5 (agree a lot), with higher scores indicating greater perceived positive aspects of caregiving. |
The PACS-6 will be completed at baseline, 6-week posttest, and 12-week follow-up.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
Time Frame: The CompACT will be completed at baseline, 6-week posttest, and 12-week follow-up.
|
The Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) is a 23-item scale to assess caregiver psychological flexibility, consisting of three subscales: openness to experience (10 items), behavioral awareness (5 items), and engagement in valued actions (8 items). Responses range from 0 (strongly disagree) to 6 (strongly agree). |
The CompACT will be completed at baseline, 6-week posttest, and 12-week follow-up.
|
|
Adherence Data
Time Frame: Adherence will be measured 6 weeks post baseline.
|
Adherence to the program: At the end of each session users are given a message that the session is complete and they "click to end session". This allows them to return to the next session the next time they visit the program and it alerts the researchers that a session is complete. Adherence will be assessed by counting the number of modules that the users completed. If a user has completed 75% of the content and has not clicked to end the session, it will be considered as a completed module. |
Adherence will be measured 6 weeks post baseline.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1P30AG086642 (U.S. NIH Grant/Contract)
- 5P30AG086642-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
No identifying data will be shared outside of the IRB approved study team.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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