Clinical trial NCT05043441: A Ten-Week Online Acceptance and Commitment Therapy Intervention for Family Caregivers of People With Dementia
Official title: A Ten-Week Online Acceptance and Commitment Therapy Intervention Guided by a Coach for Family Caregivers of People With Dementia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
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: Alzheimer's Association
First posted: 2021-09-14
Enrollment: 33
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: This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 32 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

Detailed description: This randomized controlled trial aims to assess the effects of a coach-guided ten-week videoconferencing acceptance and commitment therapy (ACT) program on mental health outcomes in depressed family caregivers of people with dementia (PwD) compared to the control group. A total of 32 family caregivers of PwD who meet the eligibility criteria will be recruited and randomized to either the intervention group or the control group. Caregivers randomly assigned to the intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with supplemental psychoeducation materials provided. Caregivers randomly assigned to the control group will receive care as usual with psychoeducation materials provided during the study period. Outcomes regarding caregivers' mental health and ACT processes will be collected at three time points (i.e., pretest, posttest, and 3-month follow-up) and compared between groups over time. The hypotheses are that the ACT group will show improvements in depressive symptoms, other mental health outcomes, and ACT process measures at posttest and 3-month follow-up, compared to the control group.

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
* having at least mild depression as measured by the Patient Health Questionnaire (PHQ)-9
* 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
* 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 6 months or
* having the possibility of study dropouts due to medical conditions of caregivers (e.g., surgery that may affect mental health) and their relatives 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 3 month follow-up on the Patient Health Questionnaire-9
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
Secondary outcomes:
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Generalized Anxiety Disorder-7
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Perceived Stress Scale
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the World Health Organization Quality of Life - Psychological health component
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Meuser Caregiver Grief Inventory
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Caregiver Guilt Questionnaire
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Self-Compassion Scale- Short Form
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Action and Acceptance Questionnaire-II
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Cognitive Fusion Questionnaire
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3-month follow-up on the Engaged Living Scale
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
measure: Change from baseline to immediately after the intervention and 3 month follow-up on the Zarit Burden Interview
timeFrame: Change from baseline to immediately after the intervention and 3 month follow-up
Other outcomes:
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: