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

NCT05518968 | Withdrawn

• 1 other identifier: IRB-300009858
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Acceptance and Commitment Therapy; Alzheimer's Disease; Burden; Caregivers; Dementia; Mindfulness; Self-compassion; Stress; Anxiety; Guilt; Grief; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Change from baseline to immediately after the 8-week intervention on the Patient Health Questionnaire-9

  The Patient Health Questionnaire-9 is a 9-item questionnaire assessing depressive symptoms on a scale of 0 to 3. Scores range from 0 to 27. Higher scores indicate greater symptomatology in depression.

  Change from baseline to immediately after the 8-week intervention

Secondary Outcomes (11)

• Change from baseline to immediately after the 8-week intervention on the Generalized Anxiety Disorder-7

  Change from baseline to immediately after the 8-week intervention

• Change from baseline to immediately after the 8-week intervention on the Perceived Stress Scale

  Change from baseline to immediately after the 8-week intervention

• Change from baseline to immediately after the 8-week intervention on the World Health Organization Quality of Life - Psychological health component

  Change from baseline to immediately after the 8-week intervention

• Change from baseline to immediately after the 8-week intervention on the Zarit Burden Interview

  Change from baseline to immediately after the 8-week intervention

• Change from baseline to immediately after the 8-week intervention on the Marwit-Meuser Caregiver Grief Inventory Brief-Form

  Change from baseline to immediately after the 8-week intervention

Other Outcomes (1)

• System Usability Scale

  immediately after the 8-week intervention

Study Arms (1)

Acceptance and Commitment Therapy

EXPERIMENTAL

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

Behavioral: Acceptance and commitment therapy

Interventions

Acceptance and commitment therapy BEHAVIORAL

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

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Depression; Alzheimer Disease; Dementia; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Areum Han, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)