Clinical trial NCT05518968: Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia
Official title: An Eight-week Program for Family Caregivers of People With Dementia Involving Coach-guided Videoconferencing Sessions With the Use of a Web App Based on Acceptance and Commitment Therapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Keywords: Acceptance and Commitment Therapy
Alzheimer's Disease
Burden
Caregivers
Dementia
Mindfulness
Self-compassion
Stress
Anxiety
Guilt
Grief
Telemedicine
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews.

Detailed description: The purpose of the pilot study is to assess the effects of an 8-week program on improving mental health in depressed family caregivers of people with dementia. The program will involve 8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy (ACT) for 8 weeks. Also, the study aims to understand these caregivers' experiences in the program, including their perspectives on the app features and contents. We aim to recruit 8-10 people for this pilot project. Outcomes regarding caregivers' mental health and ACT processes will be collected at pretest and posttest (after the completion of the 8-week program) and compared over time (i.e., posttest scores compared to pretest). At posttest, acceptability and perceived usability of the app will be evaluated using the 10-item System Usability Scale and 30-40 minute individual interviews. Participants' characteristics will be summarized using descriptive statistics. Either the Wilcoxon signed-rank test (a non-parametric test) or the paired sample t-test (a parametric test) will be performed to test the exploratory hypothesis that participants' scores for the outcome measures would significantly improve at posttest compared to pretest. Because of the exploratory nature of the study, no adjustment of p values will be conducted for multiple statistical comparisons of the outcome measures. Statistical significance will be set at p \<.05, and the effect sizes derived from this pilot study will form a basis for determining a sample size with sufficient statistical power required for a subsequent clinical trial. Caregivers' experiences in the app use and perspectives on the developed app will be explored using individual Zoom interviews. Interpretative phenomenological analysis will be used to analyze the interview data.

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 web-enabled device (e.g., a smartphone, a tablet, or a laptop/desktop) with the internet access at home

Exclusion Criteria:

* having cognitive, physical, or sensory deficits or language barriers (non-English communicator) that might impede study participation
* receiving a psychological therapy at the time of recruitment
* having a prior experience in acceptance and commitment therapy
* having psychiatric hospitalizations in the previous two years
* considering or planning to place relatives with dementia in a nursing home within 3 months
* recent frequent hospitalizations of their relatives with dementia that might contribute to study dropout

Primary outcomes:
measure: Change from baseline to immediately after the 8-week intervention on the Patient Health Questionnaire-9
timeFrame: Change from baseline to immediately after the 8-week intervention
Secondary outcomes:
measure: Change from baseline to immediately after the 8-week intervention on the Generalized Anxiety Disorder-7
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Perceived Stress Scale
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the World Health Organization Quality of Life - Psychological health component
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Zarit Burden Interview
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Marwit-Meuser Caregiver Grief Inventory Brief-Form
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Caregiver Guilt Questionnaire
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Self-Compassion Scale-Short Form
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Action and Acceptance Questionnaire-II
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Cognitive Fusion Questionnaire
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Engaged Living Scale
timeFrame: Change from baseline to immediately after the 8-week intervention
measure: Change from baseline to immediately after the 8-week intervention on the Five Facet Mindfulness Questionnaire
timeFrame: Change from baseline to immediately after the 8-week intervention
Other outcomes:
measure: System Usability Scale
timeFrame: immediately after the 8-week 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: