Caregiver BurdenPhase 3NCT05749939
Acceptance Commitment Therapy for Caregivers of People with Memory Loss
A Phase 3 study testing Acceptance and Commitment Therapy in people with Caregiver Burden and Behavioral and Psychiatric Symptoms of Dementia, run by Utah State University at 1 site in United States.
Trial summary
Family caregivers for persons with dementia report high levels of depression, stress, and burden. Caregivers' limited time, transportation constraints, and unpredictable schedules make on-line, self-guided interventions more accessible and scalable. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Behavioral and Psychiatric Symptoms of Dementia, Depressive Symptoms
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 21 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identification as a family caregiver to a person with dementia or other significant memory loss
- Interest in taking part in an on-line self-guided program with multiple assessments up through 6-week follow-up
- 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)
- Ability to read/write English
- Access to a computer/smartphone/tablet with Internet
- 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.
Who cannot join
- Not caring for a family caregiver to a person with dementia or other significant memory loss
- Not interested in an on-line self-guided program with multiple assessments up through 6-week follow-up
- 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)
- Inability to read/write English
- Does not have reliable access to a computer/smartphone/tablet with Internet.
- Lives outside of the United States
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Online Acceptance Commitment Therapy for Caregivers: a Fully Longitudinal Mixed Methods RC
Family caregivers for persons with dementia report high levels of depression, stress, and burden. Caregivers' limited time, transportation constraints, and unpredictable schedules make on-line, self-guided interventions more accessible and scalable. Acceptance and Commitment Therapy (ACT) is an established and effective in-person therapy, well-suited to the dementia care giving context where caregivers cannot minimize stress exposure, and report difficult thoughts and emotions. ACT for Caregivers is an on-line self-guided ACT intervention that showed effectiveness in a Stage I pilot (n=52) with participants reporting decreased depressive symptoms, stressful reactions to caring, and caregiver burden, and increased quality of life and positive aspects of caring (all p <.05). Learning from the pilot, the current Stage III intervention will shorten the program from 10 sessions to 6 sessions. The investigators introduce a wait list randomized control trial (RCT) design with fully longitudinal mixed methods to evaluate ACT for Caregivers. Data will be collected at pretest, post-test, and 6-weeks follow-up. Study aims are: 1) to evaluate ACT for Caregivers in a larger sample using an RCT, 2) to understand user experiences and the process of change by collecting short response data from all participants at all time points and interviewing a subset of participants in-depth at two time points, 3) to integrate quantitative and qualitative findings and examine areas of convergence and divergence. This project offers a promising prevention and intervention program to support family caregivers that is scalable, at low cost and with high impact.
Read the detailed description
Literature Review An estimated 6.2 million Americans live with Alzheimer's disease or a related dementia (ADRD), and over 11 million family caregivers currently assist a person with ADRD. The combination of cognitive impairment, behavioral symptoms, and loss of a reciprocal relationship can be very challenging for caregivers. Chronic stress can affect caregivers' mental and physical health, and sometimes lead to lower quality of care for the person with ADRD. Research indicates promising pathways to support caregiver mental health through interventions that address coping skills, self-care, and commitment to personal values.
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:
- to improve wellbeing of 100 family caregivers for persons with ADRD via an online, self- guided intervention
- to complete a Stage III study with sufficient methodological rigor to provide evidence of program effectiveness and justify more widespread implementation of this program.
- 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.
- to understand how caregivers' experience changes over time within and following an intervention
- 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
- Caregiver Burden, Behavioral and Psychiatric Symptoms of Dementia, Depressive Symptoms, Quality of Life, Psychological Flexibility, Sleep Quality
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, Caregivers of people with dementia
- Medical subject headings
- Caregiver Burden, Behavior, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Receives access to the online ACT course immediately after enrollment Receives: Behavioral: Acceptance and Commitment Therapy |
| Waitlist | No intervention | Receives access to the online ACT course 30 days after enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean group (waitlist/treatment) differences in caregiver burden
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Caregiver burden is measured by a 12-item [short] caregiver burden scale. Participants rate the impact of caregiving on multiple aspects of health (response range 0 never to 4 nearly always). A total possible summed scores range from 0 to 48; higher scores indicate higher burden.
Measured: 30 days
Mean group (waitlist/treatment) differences in depressive symptoms
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Depressive symptoms are measured by 10-item [short] Center for Epidemiological Studies Depression Scale (CES-D). Participants rate the frequency of depressive symptoms during the past week. Responses range from 1 rarely or none of the time to 4 all of the time, with possible summed scores ranging from 10 to 40; higher scores indicate more depressive symptoms.
Measured: 30 days
Mean group (waitlist/treatment) differences in positive aspects of caregiving
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Positive aspects of caregiving will be measured using a 9-item Positive Aspects of Caregiving measure. Items use the following stem "Providing help to (name) has…", with example items such as "made me feel useful" and "enabled me to appreciate life more." Responses range from 1 disagree a lot to 5 agree a lot, and items are summed with a possible score range from 9 to 45; higher scores indicate more positive aspects of caregiving.
Measured: 30 days
Mean group (waitlist/treatment) differences in sleep quality
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Sleep quality will be measured by a 1-item Sleep Quality Scale ranging from 0 terrible to 10 excellent, with higher scores indicating higher quality. Respondents are asked to consider the overall quality of sleep on most nights over the last seven days only.
Measured: 30 days
Mean group (waitlist/treatment) differences in psychological flexibility
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Psychological flexibility will be measured by the 23-item CompACT consisting of three subscales: openness to experience (10 items; possible score range 0 to 60), behavioral awareness (5 items; possible score range 0 to 30), and valued actions (8 items; possible score range 0 to 48). Responses range from 0 strongly disagree to 6 strongly agree. Some items are reverse scored. Lower scores indicate more psychological flexibility.
Measured: 30 days
Mean group (waitlist/treatment) differences in quality of life
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Quality of life will be measured by a 1-item visual analogue scale ranging from 0 to 100, with higher scores indicating higher quality of life.
Measured: 30 days
Within person change from Pretest measures at Posttest and Follow up in caregiver burden
Change over time for all participants comparing scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Caregiver burden is measured by a 12-item [short] caregiver burden scale. Participants rate the impact of caregiving on multiple aspects of health (response range 0 never to 4 nearly always). A total possible summed scores range from 0 to 48; higher scores indicate higher burden.
Measured: Pretest before intervention, 30 days of treatment access, and 6 weeks after initial 30 day period
Within person change from Pretest measures at Posttest and Follow up in depressive symptoms
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Depressive symptoms are measured by 10-item [short] Center for Epidemiological Studies Depression Scale (CES-D). Participants rate the frequency of depressive symptoms during the past week. Responses range from 1 rarely or none of the time to 4 all of the time, with possible summed scores ranging from 10 to 40; higher scores indicate more depressive symptoms.
Measured: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Within person change from Pretest measures at Posttest and Follow up in positive aspects of caregiving
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Positive aspects of caregiving will be measured using a 9-item Positive Aspects of Caregiving measure. Items use the following stem "Providing help to (name) has…", with example items such as "made me feel useful" and "enabled me to appreciate life more." Responses range from 1 disagree a lot to 5 agree a lot, and items are summed with a possible score range from 9 to 45; higher scores indicate more positive aspects of caregiving.
Measured: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Within person change from Pretest measures at Posttest and Follow up in sleep quality
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Sleep quality will be measured by a 1-item Sleep Quality Scale ranging from 0 terrible to 10 excellent, with higher scores indicating higher quality. Respondents are asked to consider the overall quality of sleep on most nights over the last seven days only.
Measured: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Within person change from Pretest measures at Posttest and Follow up in psychological flexibility
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Psychological flexibility will be measured by the 23-item CompACT consisting of three subscales: openness to experience (10 items; possible score range 0 to 60), behavioral awareness (5 items; possible score range 0 to 30), and valued actions (8 items; possible score range 0 to 48). Responses range from 0 strongly disagree to 6 strongly agree. Some items are reverse scored. Lower scores indicate more psychological flexibility.
Measured: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Within person change from Pretest measures at Posttest and Follow up in quality of life
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Quality of life will be measured by a 1-item visual analogue scale ranging from 0 to 100, with higher scores indicating higher quality of life.
Measured: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Description of participant experience using this intervention
Qualitative interviews will capture how participant experiences support, refine, and contradict acceptance commitment therapy (ACT) principles.
Measured: 30 days
Change from Post intervention experience at Follow up
Qualitative interviews will capture changes in participant's attitudes and enactment of principles learned during the treatment.
Measured: 30 days after access to program to 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start16 Feb 2023
- Primary completion21 Jan 2024
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized wait list control trial. Participants are assigned to treatment and wait list groups. Wait list participants receive treatment after 4 weeks of waiting. Treatment participants receive treatment immediately.
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrey Juhasz, Utah State University
- Investigators
- Audrey C Juhasz, PhD, Principal investigator, Utah State UniversityElizabeth Fauth, PhD, Study director, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749939
- Sponsor's protocol ID
- 13040
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Publications
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.
PubMed 34233133Plano 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.
PubMed 33868913Cuijpers 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.
PubMed 20406528Godwin 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.
PubMed 23528881Bayly 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.
PubMed 31975685Ng 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.
PubMed 19469918Brown 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.
PubMed 27558740Levin 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.
PubMed 24313693Coon 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.
PubMed 14570964Han 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.
PubMed 32659142Losada 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.
PubMed 21061414Losada 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.
PubMed 26075381Hayes 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.
PubMed 16300724Coen 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.
PubMed 11893838
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Online Acceptance Commitment Therapy for Caregivers: a Fully Longitudinal Mixed Methods RC
- ClinicalTrials.gov ID
- NCT05749939
- Acronym / sponsor ID
- 13040
- Conditions
- Caregiver Burden, Behavioral and Psychiatric Symptoms of Dementia, Depressive Symptoms, Quality of Life, Psychological Flexibility, Sleep Quality
- Keywords
- Acceptance and Commitment Therapy, Caregivers of people with dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Family caregivers for persons with dementia report high levels of depression, stress, and burden. Caregivers' limited time, transportation constraints, and unpredictable schedules make on-line, self-guided interventions more accessible and scalable. Acceptance and Commitment Therapy (ACT) is an established and effective in-person therapy, well-suited to the dementia care giving context where caregivers cannot minimize stress exposure, and report difficult thoughts and emotions. ACT for Caregivers is an on-line self-guided ACT intervention that showed effectiveness in a Stage I pilot (n=52) with participants reporting decreased depressive symptoms, stressful reactions to caring, and caregiver burden, and increased quality of life and positive aspects of caring (all p <.05). Learning from the pilot, the current Stage III intervention will shorten the program from 10 sessions to 6 sessions. The investigators introduce a wait list randomized control trial (RCT) design with fully longitudinal mixed methods to evaluate ACT for Caregivers. Data will be collected at pretest, post-test, and 6-weeks follow-up. Study aims are: 1) to evaluate ACT for Caregivers in a larger sample using an RCT, 2) to understand user experiences and the process of change by collecting short response data from all participants at all time points and interviewing a subset of participants in-depth at two time points, 3) to integrate quantitative and qualitative findings and examine areas of convergence and divergence. This project offers a promising prevention and intervention program to support family caregivers that is scalable, at low cost and with high impact.
Detailed description
Literature Review An estimated 6.2 million Americans live with Alzheimer's disease or a related dementia (ADRD), and over 11 million family caregivers currently assist a person with ADRD. The combination of cognitive impairment, behavioral symptoms, and loss of a reciprocal relationship can be very challenging for caregivers. Chronic stress can affect caregivers' mental and physical health, and sometimes lead to lower quality of care for the person with ADRD. Research indicates promising pathways to support caregiver mental health through interventions that address coping skills, self-care, and commitment to personal values.
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:
- to improve wellbeing of 100 family caregivers for persons with ADRD via an online, self- guided intervention
- to complete a Stage III study with sufficient methodological rigor to provide evidence of program effectiveness and justify more widespread implementation of this program.
- 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.
- to understand how caregivers' experience changes over time within and following an intervention
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized wait list control trial. Participants are assigned to treatment and wait list groups. Wait list participants receive treatment after 4 weeks of waiting. Treatment participants receive treatment immediately.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Acceptance and Commitment TherapyReceives access to the online ACT course immediately after enrollment |
| Waitlist | No intervention | –Receives access to the online ACT course 30 days after enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identification as a family caregiver to a person with dementia or other significant memory loss
- Interest in taking part in an on-line self-guided program with multiple assessments up through 6-week follow-up
- 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)
- Ability to read/write English
- Access to a computer/smartphone/tablet with Internet
Key exclusion criteria (7 listed)
- Not caring for a family caregiver to a person with dementia or other significant memory loss
- Not interested in an on-line self-guided program with multiple assessments up through 6-week follow-up
- 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)
- Inability to read/write English
- Does not have reliable access to a computer/smartphone/tablet with Internet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAcceptance 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. | Behavioural | Treatment |
Primary outcome
Mean group (waitlist/treatment) differences in caregiver burden
Time frame: 30 days
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Caregiver burden is measured by a 12-item [short] caregiver burden scale. Participants rate the impact of caregiving on multiple aspects of health (response range 0 never to 4 nearly always). A total possible summed scores range from 0 to 48; higher scores indicate higher burden.
Mean group (waitlist/treatment) differences in depressive symptoms
Time frame: 30 days
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Depressive symptoms are measured by 10-item [short] Center for Epidemiological Studies Depression Scale (CES-D). Participants rate the frequency of depressive symptoms during the past week. Responses range from 1 rarely or none of the time to 4 all of the time, with possible summed scores ranging from 10 to 40; higher scores indicate more depressive symptoms.
Mean group (waitlist/treatment) differences in positive aspects of caregiving
Time frame: 30 days
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Positive aspects of caregiving will be measured using a 9-item Positive Aspects of Caregiving measure. Items use the following stem "Providing help to (name) has…", with example items such as "made me feel useful" and "enabled me to appreciate life more." Responses range from 1 disagree a lot to 5 agree a lot, and items are summed with a possible score range from 9 to 45; higher scores indicate more positive aspects of caregiving.
Mean group (waitlist/treatment) differences in sleep quality
Time frame: 30 days
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Sleep quality will be measured by a 1-item Sleep Quality Scale ranging from 0 terrible to 10 excellent, with higher scores indicating higher quality. Respondents are asked to consider the overall quality of sleep on most nights over the last seven days only.
Mean group (waitlist/treatment) differences in psychological flexibility
Time frame: 30 days
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Psychological flexibility will be measured by the 23-item CompACT consisting of three subscales: openness to experience (10 items; possible score range 0 to 60), behavioral awareness (5 items; possible score range 0 to 30), and valued actions (8 items; possible score range 0 to 48). Responses range from 0 strongly disagree to 6 strongly agree. Some items are reverse scored. Lower scores indicate more psychological flexibility.
Mean group (waitlist/treatment) differences in quality of life
Time frame: 30 days
Group differences between waitlist and treatment group scores after the treatment group has had access to the treatment for 30 days and the waitlist group has not received any intervention for the same amount of time. Quality of life will be measured by a 1-item visual analogue scale ranging from 0 to 100, with higher scores indicating higher quality of life.
Within person change from Pretest measures at Posttest and Follow up in caregiver burden
Time frame: Pretest before intervention, 30 days of treatment access, and 6 weeks after initial 30 day period
Change over time for all participants comparing scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Caregiver burden is measured by a 12-item [short] caregiver burden scale. Participants rate the impact of caregiving on multiple aspects of health (response range 0 never to 4 nearly always). A total possible summed scores range from 0 to 48; higher scores indicate higher burden.
Within person change from Pretest measures at Posttest and Follow up in depressive symptoms
Time frame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Depressive symptoms are measured by 10-item [short] Center for Epidemiological Studies Depression Scale (CES-D). Participants rate the frequency of depressive symptoms during the past week. Responses range from 1 rarely or none of the time to 4 all of the time, with possible summed scores ranging from 10 to 40; higher scores indicate more depressive symptoms.
Within person change from Pretest measures at Posttest and Follow up in positive aspects of caregiving
Time frame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Positive aspects of caregiving will be measured using a 9-item Positive Aspects of Caregiving measure. Items use the following stem "Providing help to (name) has…", with example items such as "made me feel useful" and "enabled me to appreciate life more." Responses range from 1 disagree a lot to 5 agree a lot, and items are summed with a possible score range from 9 to 45; higher scores indicate more positive aspects of caregiving.
Within person change from Pretest measures at Posttest and Follow up in sleep quality
Time frame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Sleep quality will be measured by a 1-item Sleep Quality Scale ranging from 0 terrible to 10 excellent, with higher scores indicating higher quality. Respondents are asked to consider the overall quality of sleep on most nights over the last seven days only.
Within person change from Pretest measures at Posttest and Follow up in psychological flexibility
Time frame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Psychological flexibility will be measured by the 23-item CompACT consisting of three subscales: openness to experience (10 items; possible score range 0 to 60), behavioral awareness (5 items; possible score range 0 to 30), and valued actions (8 items; possible score range 0 to 48). Responses range from 0 strongly disagree to 6 strongly agree. Some items are reverse scored. Lower scores indicate more psychological flexibility.
Within person change from Pretest measures at Posttest and Follow up in quality of life
Time frame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
Change over time for all participants comparing changes in scores from before the intervention, to after 30 day of access to the treatment, and again 6 weeks after the end of the initial 30 day period. Quality of life will be measured by a 1-item visual analogue scale ranging from 0 to 100, with higher scores indicating higher quality of life.
Description of participant experience using this intervention
Time frame: 30 days
Qualitative interviews will capture how participant experiences support, refine, and contradict acceptance commitment therapy (ACT) principles.
Change from Post intervention experience at Follow up
Time frame: 30 days after access to program to 6 weeks later
Qualitative interviews will capture changes in participant's attitudes and enactment of principles learned during the treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 34233133Fauth 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.
- BackgroundPlano 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.
- Background: PubMed 33868913Dochat 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.
- Background: PubMed 20406528Cuijpers 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.
- Background: PubMed 23528881Godwin 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.
- Background: PubMed 31975685Bayly 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.
- Background: PubMed 19469918Ng 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.
- Background: PubMed 27558740Brown 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.
- Background: PubMed 24313693Levin 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.
- Background: PubMed 14570964Coon 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.
- Background: PubMed 32659142Han 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.
- Background: PubMed 21061414Losada 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.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey C Juhasz, PhD principal investigator
Utah State University
Elizabeth Fauth, PhD study director
Utah State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acceptance and Commitment Therapy in people with Caregiver Burden and Behavioral and Psychiatric Symptoms of Dementia, run by Utah State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean group (waitlist/treatment) differences in caregiver burden (time frame: 30 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749939, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.