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Online Self-guided ACT for Dementia Caregivers: Evaluating Psychological Flexibility as the Mechanism to Improve Psychological Distress
Sponsor study identifier
NIH
Secondary identifiers
interventional
120
1 country
1
Study Start
July 20, 2026
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2026
Actual (reported)September 14, 2026
Actual (reported)September 28, 2026
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Depression, Anxiety, and Stress Scale (DASS-21)
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.
Zarit Burden Interview-6 (ZBI-6)
The ZBI-6 will be completed at baseline, 6-week posttest, and 12-week follow-up.
Positive Aspects of Caregiving Scale-6 (PACS-6)
The PACS-6 will be completed at baseline, 6-week posttest, and 12-week follow-up.
Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT)
The CompACT will be completed at baseline, 6-week posttest, and 12-week follow-up.
Adherence Data
Adherence will be measured 6 weeks post baseline.
The treatment group will immediately receive access to the intervention following completion of the baseline survey.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Utah State University
Logan, Utah, 84322, United States
Fauth EB, Novak JR, Levin ME. Outcomes from a pilot online Acceptance and Commitment Therapy program for dementia family caregivers. Aging Ment Health. 2022 Aug;26(8):1620-1629. doi: 10.1080/13607863.2021.1942432. Epub 2021 Jul 7.
First Submitted
September 14, 2026
First Posted
September 28, 2026
Study Start
July 20, 2026
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 28, 2026
Record last verified: 2026-09
No identifying data will be shared outside of the IRB approved study team.
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Source: ClinicalTrials.gov.
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