Acceptance Commitment Therapy for Caregivers of People with Memory Loss
NCT ID: NCT05749939
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
121 participants
INTERVENTIONAL
2023-02-16
2024-01-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A growing number of studies demonstrate that Acceptance and Commitment Therapy (ACT) is effective in reducing distress across a broad number of conditions and contexts. ACT combines the skills of acceptance, cognitive defusion, being present, self as context, values, and committed action to help individuals engage with a meaningful life. ACT helps individuals feel less guided by rigid or critical thoughts, and it teaches individuals to be nonjudgmental and present when difficult experiences arise. A goal of ACT is to help people develop psychological flexibility, meaning being capable of experiencing and living with difficult thoughts and emotions, while still pursue what matters to the individual.
Caregivers of persons with ADRD often disconnect from meaningful activities and relationships due to the ongoing supervision needed for their loved one. Caregivers experience feelings of grief and loss, even while their loved one is still alive, and sometimes use avoidant approaches to minimize feelings of loss, guilt, and exhaustion. ACT with a therapist is highly effective in helping family caregivers of persons with ADRD to reduce depression, anxiety, and experiential avoidance.
While ACT is traditionally delivered in person with a trained therapist, it has also demonstrated effective psychological and emotional benefits in an online format. Online interventions are well-suited for dementia caregivers, who have limited time, transportation constraints, and unpredictable care schedules. Online programs can be accessed conveniently around care routines, do not require driving or finding supervision for the care receiver, are low-cost for users and providers, and are able to relay informational, emotional, and task-specific support, even to hard-to-reach populations, such as those living in rural areas. Clinical trials indicate that online therapy is effective, arguably equally effective to face-to-face therapy.
The Current Study In 2021, USU researchers published results of a pilot study for an online, self-guided ACT for Caregivers of persons with ADRD. Participation in this 10-session online intervention was associated with decreased depressive symptoms, care-related burden, and stress reactions to behavioral symptoms. Caregivers also reported increased positive aspects of caregiving and quality of life. Importantly, the pilot study lacked a control condition. There is also increasing evidence that ACT, can be delivered more concisely; ACT research in other populations suggests a brief approach may be equally effective as longer programs. Given the time constraints of this population, shorter programs may be more appealing for users. The primary aim of the current project is to use a randomized waitlist controlled trial design to determine whether a shorter six session ACT intervention is effective in improving relevant caregiver outcomes.
While the 2021 pilot demonstrated that ACT could improve caregivers outcomes, the investigators were unable to examine the specific ways that participants utilized ACT in their lives. In other words, currently the field recognizes that individuals can change, but knows less about the mechanisms of change, which is important in moving these interventions forward, and on a larger scale. A mixed methods design will allow for the examination of this project's second aim to integrate participants' quantitative data with descriptions of their lived experience to better understand how the intervention promotes positive change.
Research Objectives The current study uses a randomized wait-list controlled trial design and fully longitudinal mixed methods analysis to examine the effectiveness of a condensed online ACT for Caregivers program.
Aim 1: Empirically evaluate the effectiveness of a six-session online ACT intervention in reducing negative aspects of caregiving (depressive symptoms, burden, stressful reactions to memory and behavior problems) and promotion of positive thoughts and behaviors (recognition of positive aspects of caregiving, improved sleep quality, and increased quality of life).
Aim 2: Qualitatively explore caregivers' lived experience with the intervention and ways that caregivers are applying the skills in their lives and examine the extent to which caregivers' descriptions align with and expand on theory-based mechanisms of change.
Impact
Anticipated Outcomes
The anticipated outcomes of our study are:
1. to improve wellbeing of 100 family caregivers for persons with ADRD via an online, self- guided intervention
2. to complete a Stage III study with sufficient methodological rigor to provide evidence of program effectiveness and justify more widespread implementation of this program.
3. to produce necessary documentation of effectiveness to support pursuit of further funding through the National Institute of Health (NIH) or the National Institute of Mental Health (NIMH). NIH expects to spend 3.4+ billion in ADRD grants in the next year.
4. to understand how caregivers' experience changes over time within and following an intervention
5. to understand how ACT-based skills act as potential drivers of change for family caregivers.
Implications Our study is a robust Stage III test of the effectiveness of a shorter (more user-friendly) version of ACT for Caregivers, which has not yet been empirically tested using a randomized control design. While evidence suggests that ACT in other populations can be delivered effectively in as little as one face-to- face session, little is known about the 'dosage' required for online, self-guided interventions. If our shorter ACT for Caregivers protocol is effective in improving caregiver outcomes, the program will move forward towards the implementation goal of being offered for free (or at very low cost) through Utah State University's Alzheimer's Research Center.
The ACT for Caregivers Stage I pilot study (with the longer 10-session format) demonstrated improved outcomes but inadequate power to examine more nuanced mechanisms for change, and without qualitative data collected. With a larger sample, the present study allows for adequate power to examine change mechanisms quantitatively. Qualitative interviews and mixed methods approaches are added to the current study to understand change, and how ACT-related skills contribute to change. Although fully longitudinal mixed methods research is becoming more common in health research, it is still novel in program development and evaluation with ADRD caregivers. Fully longitudinal mixed methods research allows for a holistic examination of whether and how change occurs over time and is therefore highly relevant for evaluating promising intervention programs in the growing population of family caregivers for persons with ADRD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Receives access to the online ACT course immediately after enrollment
Acceptance and Commitment Therapy
Acceptance and commitment therapy (ACT) combines the skills of acceptance, cognitive defusion, being present, self as context, values, and committed action to help individuals engage with a meaningful life. A goal of ACT is to help people develop psychological flexibility, meaning they can experience and live with difficult thoughts and emotions, and still pursue what matters to them. The current project is an online, self-guided, 6-session intervention. Each session is expected to take about 30 minutes each, and the entire course will take approximately 3-4 weeks to complete, as users are encouraged to take a few days in between sessions. Within each session, participants will read about concepts and ACT metaphors, apply ACT concepts to general and care- specific vignettes, and apply ACT concepts to their own lives and care situations. Interactive experiences are included in each session and ends with a printable summary with practice skills before proceeding.
Waitlist
Receives access to the online ACT course 30 days after enrollment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acceptance and Commitment Therapy
Acceptance and commitment therapy (ACT) combines the skills of acceptance, cognitive defusion, being present, self as context, values, and committed action to help individuals engage with a meaningful life. A goal of ACT is to help people develop psychological flexibility, meaning they can experience and live with difficult thoughts and emotions, and still pursue what matters to them. The current project is an online, self-guided, 6-session intervention. Each session is expected to take about 30 minutes each, and the entire course will take approximately 3-4 weeks to complete, as users are encouraged to take a few days in between sessions. Within each session, participants will read about concepts and ACT metaphors, apply ACT concepts to general and care- specific vignettes, and apply ACT concepts to their own lives and care situations. Interactive experiences are included in each session and ends with a printable summary with practice skills before proceeding.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Interest in taking part in an on-line self-guided program with multiple assessments up through 6-week follow-up
3. Distressed from the care giving 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)
4. Ability to read/write English
5. Access to a computer/smartphone/tablet with Internet
6. Caregiver does not have to live with the care recipient, as distress can arise with or without cohabitation, participants must live within the United States.
Exclusion Criteria
2. Not interested in an on-line self-guided program with multiple assessments up through 6-week follow-up
3. Responds with a score of 3 or less when asked "How distressed are you by caring for your family member?" (1 not at all to 10 extremely)
4. Inability to read/write English
5. Does not have reliable access to a computer/smartphone/tablet with Internet.
6. Lives outside of the United States
7. Younger than 18 years old
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Utah State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Audrey Juhasz
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Audrey C Juhasz, PhD
Role: PRINCIPAL_INVESTIGATOR
Utah State University
Elizabeth Fauth, PhD
Role: STUDY_DIRECTOR
Utah State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Utah State University
Logan, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Plano Clark VL, Anderson N, Wertz JA, Zhou Y, Schumacher K, & Miaskowski C. Conceptualizing longitudinal mixed methods designs: A methodological review of health sciences research. Journal of Mixed Methods Research. 2015; 9(4): 297-319.
Dochat C, Wooldridge JS, Herbert MS, Lee MW, Afari N. Single-Session Acceptance and Commitment Therapy (ACT) Interventions for Patients with Chronic Health Conditions: A Systematic Review and Meta-Analysis. J Contextual Behav Sci. 2021 Apr;20:52-69. doi: 10.1016/j.jcbs.2021.03.003. Epub 2021 Mar 6.
Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010 Dec;40(12):1943-57. doi: 10.1017/S0033291710000772. Epub 2010 Apr 21.
Godwin KM, Mills WL, Anderson JA, Kunik ME. Technology-driven interventions for caregivers of persons with dementia: a systematic review. Am J Alzheimers Dis Other Demen. 2013 May;28(3):216-22. doi: 10.1177/1533317513481091. Epub 2013 Mar 25.
Bayly M, Morgan D, Froehlich Chow A, Kosteniuk J, Elliot V. Dementia-Related Education and Support Service Availability, Accessibility, and Use in Rural Areas: Barriers and Solutions. Can J Aging. 2020 Dec;39(4):545-585. doi: 10.1017/S0714980819000564. Epub 2020 Jan 24.
Ng GT. Support for family caregivers: what do service providers say about accessibility, availability and affordability of services? Health Soc Care Community. 2009 Nov;17(6):590-8. doi: 10.1111/j.1365-2524.2009.00858.x. Epub 2009 May 13.
Brown M, Glendenning A, Hoon AE, John A. Effectiveness of Web-Delivered Acceptance and Commitment Therapy in Relation to Mental Health and Well-Being: A Systematic Review and Meta-Analysis. J Med Internet Res. 2016 Aug 24;18(8):e221. doi: 10.2196/jmir.6200.
Levin ME, Pistorello J, Seeley JR, Hayes SC. Feasibility of a prototype web-based acceptance and commitment therapy prevention program for college students. J Am Coll Health. 2014;62(1):20-30. doi: 10.1080/07448481.2013.843533.
Coon DW, Thompson L, Steffen A, Sorocco K, Gallagher-Thompson D. Anger and depression management: psychoeducational skill training interventions for women caregivers of a relative with dementia. Gerontologist. 2003 Oct;43(5):678-89. doi: 10.1093/geront/43.5.678.
Han A, Yuen HK, Jenkins J. Acceptance and commitment therapy for family caregivers: A systematic review and meta-analysis. J Health Psychol. 2021 Jan;26(1):82-102. doi: 10.1177/1359105320941217. Epub 2020 Jul 10.
Losada A, Marquez-Gonzalez M, Romero-Moreno R. Mechanisms of action of a psychological intervention for dementia caregivers: effects of behavioral activation and modification of dysfunctional thoughts. Int J Geriatr Psychiatry. 2011 Nov;26(11):1119-27. doi: 10.1002/gps.2648. Epub 2010 Nov 9.
Losada A, Marquez-Gonzalez M, Romero-Moreno R, Mausbach BT, Lopez J, Fernandez-Fernandez V, Nogales-Gonzalez C. Cognitive-behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for dementia family caregivers with significant depressive symptoms: Results of a randomized clinical trial. J Consult Clin Psychol. 2015 Aug;83(4):760-72. doi: 10.1037/ccp0000028. Epub 2015 Jun 15.
Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
Coen RF, O'Boyle CA, Coakley D, Lawlor BA. Individual quality of life factors distinguishing low-burden and high-burden caregivers of dementia patients. Dement Geriatr Cogn Disord. 2002;13(3):164-70. doi: 10.1159/000048648.
Gao C, Chapagain NY, Scullin MK. Sleep Duration and Sleep Quality in Caregivers of Patients With Dementia: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Aug 2;2(8):e199891. doi: 10.1001/jamanetworkopen.2019.9891.
Li R, Cooper C, Livingston G. Relationship of coping style to mood and anxiety disorders in dementia carers. Curr Opin Psychiatry. 2014 Jan;27(1):52-6. doi: 10.1097/YCO.0000000000000020.
Romero-Moreno R, Losada A, Marquez-Gonzalez M, Mausbach BT. Stressors and anxiety in dementia caregiving: multiple mediation analysis of rumination, experiential avoidance, and leisure. Int Psychogeriatr. 2016 Nov;28(11):1835-1844. doi: 10.1017/S1041610216001009. Epub 2016 Jul 26.
Walter E, Pinquart M. How Effective Are Dementia Caregiver Interventions? An Updated Comprehensive Meta-Analysis. Gerontologist. 2020 Nov 23;60(8):609-619. doi: 10.1093/geront/gnz118.
Chiao CY, Wu HS, Hsiao CY. Caregiver burden for informal caregivers of patients with dementia: A systematic review. Int Nurs Rev. 2015 Sep;62(3):340-50. doi: 10.1111/inr.12194. Epub 2015 Jun 8.
Finkel S. Introduction to behavioural and psychological symptoms of dementia (BPSD). Int J Geriatr Psychiatry. 2000 Jul;15 Suppl 1:S2-4. doi: 10.1002/(sici)1099-1166(200004)15:1+3.0.co;2-3. No abstract available.
Alzheimer's Association (2021). Alzheimer's disease facts and figures 2021. Retrieved from https://www.alz.org/alzheimers-dementia/facts-figures Oct 5, 2022.
Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
Tarlow BJ, Wisniewski SR, Belle SH, Rubert M, Ory MG, & Gallagher-Thompson D. Positive Aspects of Caregiving: Contributions of the REACH Project to the Development of New Measures for Alzheimer's Caregiving. Research on Aging. 2004; 26(4): 429-453. doi:10.1177/0164027504264493
Snyder E, Cai B, DeMuro C, Morrison MF, Ball W. A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression. J Clin Sleep Med. 2018 Nov 15;14(11):1849-1857. doi: 10.5664/jcsm.7478.
Lowenberg B, van Putten WL, Ferrant A, Ossenkoppele G, Vellenga E, Verdonck LF, Gratwohl A, Boogaerts MA. Peripheral blood progenitor cell transplantation as an alternative to autologous marrow transplantation in the treatment of acute myeloid leukemia. Stem Cells. 1997;15 Suppl 1:177-80; discussion 181. doi: 10.1002/stem.5530150823.
de Boer AG, van Lanschot JJ, Stalmeier PF, van Sandick JW, Hulscher JB, de Haes JC, Sprangers MA. Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004 Mar;13(2):311-20. doi: 10.1023/B:QURE.0000018499.64574.1f.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13040
Identifier Type: -
Identifier Source: org_study_id