Clinical trial NCT04847986: Guided Eight-week Online Acceptance and Commitment Therapy for Distressed Family Caregivers of People With Dementia
Official title: A Guided Eight-week Online Acceptance and Commitment Therapy (ACT) Intervention for Distressed Family Caregivers of People With Dementia: A Mixed-methods Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Keywords: Acceptance and Commitment Therapy
Alzheimer's Disease
Burden
Caregivers
Dementia
Mindfulness
Psychological health
Quality of life
Self-compassion
Stress
Depression
Anxiety
Guilt
Grief
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2021-04-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group. A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group. Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest. As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.

Detailed description: The pilot randomized controlled trial aims to assess effects of a guided online acceptance and commitment therapy (ACT) intervention on distressed family caregivers of people with dementia (PwD) compared to the control group. A total of 24 family caregivers of PwD who meet the inclusion criteria will be recruited and randomized to either the intervention or control group. Caregivers assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 8 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers assigned to the control group will receive care as usual with psychoeducation materials provided. Outcomes regarding caregivers' mental health will be collected at three time points (i.e., pretest, posttest, and 1-month follow-up) and compared between groups over time. Exploratory hypotheses are that the ACT group will show decreases in caregivers' psychological distress and burden and improvements in QoL and engagement in meaningful activities at posttest and 1-month follow-up, compared to the control group. Also, the project will evaluate the feasibility of recruitment, adherence, and retention of caregivers and explore caregivers' experiences in the ACT intervention through semi-structured interviews at posttest. As part of the pretest, we will also explore caregivers' perceived impacts of COVID-19 on daily lives.

Eligibility criteria: Inclusion Criteria:

* community-dwelling adults (age 18 or over) who are currently taking the primary responsibility for the care of a relative with dementia living in the community
* devoting at least four hours daily to the care of the relative with dementia
* having at least mild symptoms of psychological distress as measured by the Depression, Anxiety and Stress Scale (DASS-21; Antony et al., 1988)
* having a computer or a smartphone with the internet access at home and
* being able to provide informed consent.

Exclusion Criteria:

* having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that impede study participation
* currently receiving a psychological therapy
* having a prior experience in ACT
* having psychiatric hospitalizations or diagnoses of mental illness in the previous two years
* taking antipsychotic or anticonvulsant medication at the time of recruitment
* considering or planning to place family members of PwD in a nursing home within four months or
* having the possibility of study dropouts due to other medical conditions of family members with dementia (e.g., conditions that may impede study participation due to frequent hospitalization or death)

Primary outcomes:
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Depression, Anxiety and Stress Scale
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Zarit Burden Interview
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
Secondary outcomes:
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the World Health Organization Quality of Life-BREF - Psychological health component
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Meuser Caregiver Grief Inventory
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Caregiver Guilt Questionnaire
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Self-Compassion Scale- Short Form
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Action and Acceptance Questionnaire-II
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Cognitive Fusion Questionnaire
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
measure: Change from baseline to immediately after the intervention and 1 month follow-up on the Engagement in Meaningful Activities Survey
timeFrame: Change from baseline to immediately after the intervention and 1 month follow-up
Other outcomes:
measure: System Usability Scale
timeFrame: immediately after the intervention
measure: Interviews of participants
timeFrame: at baseline and immediately after the intervention
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Areum Han, PhD
role: PRINCIPAL_INVESTIGATOR
References: