Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT05518968
Status:
WITHDRAWN
Last Update Posted:
2024-01-05
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We changed our plan.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: