- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07714408
The Effects of a Smartphone-Based Acceptance and Commitment Therapy Program on the Mental Health and Quality of Life of Caregivers Working in Long-Term Care Facilities
The Effects of a Smartphone-Based Acceptance and Commitment Therapy Program on the Mental Health and Quality of Life of Caregivers Working in Long-Term Care Facilities: A Randomized Controlled Trial Study
The aim of this study is to investigate whether a smartphone-based Acceptance and Commitment Therapy (ACT) program can improve the mental health and quality of life of care workers in long-term care facilities. The research question of this study is as follows: Among caregivers working in long-term care facilities, are there differences in mental health, quality of life, and job burnout between the experimental group that participated in a smartphone-based ACT program and the control group that participated in a document-based ACT program?
Participants in the experimental group will complete 70 daily sessions of a smartphone-based ACT program using Anzeilax-Plus, administered Monday through Friday over a 14-week period. Participants in the control group will complete 70 daily assignments from a document-based ACT program, administered Monday through Friday over the same 14-week period.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Woosang Hwang, Ph.D.
- Phone Number: 82-2-2077-7380
- Email: woosanghwang@sookmyung.ac.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Caregivers aged 18 years or older who provide care services to older adults in long-term care facilities, own a smartphone, and have no history of depression or other mental illnesses.
Exclusion Criteria:
- Caregivers with a history of depression or other mental illnesses, or those who do not own a smartphone.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile-based ACT group
One daily session of the smartphone-based ACT program delivered through the Anzeilax-Plus app
|
Participants will complete a daily Acceptance and Commitment Therapy (ACT) session through a mobile application on their smartphones.
|
|
Active Comparator: Document-based ACT group
One daily session of the document-based ACT program
|
Participants will complete a daily Acceptance and Commitment Therapy (ACT) session using materials provided by the research team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Depressive symptoms will be measured using the Patient Health Questionnaire-9, a 9-item self-report measure.
Each item is rated on a 4-point scale, with total scores ranging from 9 to 36.
Higher scores indicate higher levels of depressive symptoms.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Anxiety
Time Frame: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Anxiety will be measured using the Generalized Anxiety Disorder-7, a 7-item self-report measure.
Each item is rated on a 4-point scale, with total scores ranging from 7 to 28.
Higher scores indicate higher levels of anxiety.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Stress
Time Frame: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Stress will be measured using the Perceived Stress Scale-10, a 10-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 10 to 50.
Higher scores indicate higher levels of stress.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Self-esteem
Time Frame: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Self-esteem will be measured using the Rosenberg Self-Esteem Scale, a 10-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 10 to 50.
Higher scores indicate higher levels of self-esteem
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Job burnout
Time Frame: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Job burnout will be measured using the Maslach Burnout Inventory-General Survey, a 15-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 15 to 75.
Higher scores indicate higher levels of job burnout.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Quality of life (Psychological and physical well-being)
Time Frame: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Quality of life will be measured using the World Health Organization Quality of Life Scale a 15-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 15 to 75.
Higher scores indicate higher levels of quality of life.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMWU-2604-HR-020-01
- RS-2026-25477485 (Other Grant/Funding Number: National Research Foundation of Korea)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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