Videoconferencing Acceptance and Commitment Therapy With a Web App Use for Family Caregivers of People With Dementia

NCT ID: NCT05518968

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-01-01

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acceptance and Commitment Therapy

8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy

Group Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: BEHAVIORAL

8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy

Interventions

Acceptance and commitment therapy

8 weekly coach-guided videoconferencing sessions and the use of a web app based on acceptance and commitment therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Areum Han

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areum Han, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300009858

Identifier Type: -

Identifier Source: org_study_id