Clinical trial NCT05749939: Acceptance Commitment Therapy for Caregivers of People with Memory Loss
Official title: Brief Online Acceptance Commitment Therapy for Caregivers: a Fully Longitudinal Mixed Methods RC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Caregiver Burden
Behavioral and Psychiatric Symptoms of Dementia
Depressive Symptoms
Quality of Life
Psychological Flexibility
Sleep Quality
Positive Aspects of Caregiving
Keywords: Acceptance and Commitment Therapy
Caregivers of people with dementia
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

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.

Eligibility criteria: Inclusion Criteria:

1. Self-identification as a family caregiver to a person with dementia or other significant memory loss
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:

1. Not caring for a family caregiver to a person with dementia or other significant memory loss
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

Primary outcomes:
measure: Mean group (waitlist/treatment) differences in caregiver burden
timeFrame: 30 days
measure: Mean group (waitlist/treatment) differences in depressive symptoms
timeFrame: 30 days
measure: Mean group (waitlist/treatment) differences in positive aspects of caregiving
timeFrame: 30 days
measure: Mean group (waitlist/treatment) differences in sleep quality
timeFrame: 30 days
measure: Mean group (waitlist/treatment) differences in psychological flexibility
timeFrame: 30 days
measure: Mean group (waitlist/treatment) differences in quality of life
timeFrame: 30 days
measure: Within person change from Pretest measures at Posttest and Follow up in caregiver burden
timeFrame: Pretest before intervention, 30 days of treatment access, and 6 weeks after initial 30 day period
measure: Within person change from Pretest measures at Posttest and Follow up in depressive symptoms
timeFrame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
measure: Within person change from Pretest measures at Posttest and Follow up in positive aspects of caregiving
timeFrame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
measure: Within person change from Pretest measures at Posttest and Follow up in sleep quality
timeFrame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
measure: Within person change from Pretest measures at Posttest and Follow up in psychological flexibility
timeFrame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
measure: Within person change from Pretest measures at Posttest and Follow up in quality of life
timeFrame: Pretest before intervention, 30 days of program access, and 6 weeks after initial 30 day period
measure: Description of participant experience using this intervention
timeFrame: 30 days
measure: Change from Post intervention experience at Follow up
timeFrame: 30 days after access to program to 6 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Audrey C Juhasz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Utah State University
name: Elizabeth Fauth, PhD
role: STUDY_DIRECTOR
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