Acceptance Commitment Therapy for Caregivers of People with Memory Loss

NCT05749939 | Completed Phase 3

• 1 other identifier: 13040
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  30 days after access to program to 6 weeks later

Study Arms (2)

Treatment

EXPERIMENTAL

Receives access to the online ACT course immediately after enrollment

Behavioral: Acceptance and Commitment Therapy

Waitlist

NO INTERVENTION

Receives access to the online ACT course 30 days after enrollment

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Utah State University: lead

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (28)

• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Caregiver Burden; Behavior; Depression; Sleep Initiation and Maintenance Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Audrey C Juhasz, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

• Elizabeth Fauth, PhD

  Utah State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: March 1, 2023
• Study Start: February 16, 2023
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Dr. Elizabeth Fauth will review requests and criteria.

Locations

US (1)