Healthy AdultsNCT07714408
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 study testing Mobile-based Acceptance and Commitment Therapy (ACT) program and Document-based Acceptance and Commitment Therapy (ACT) Program in people with Healthy Adults, run by Sookmyung Women's University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Mobile-based Acceptance and Commitment Therapy (ACT) program and Document-based Acceptance and Commitment Therapy (ACT) Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 27 Jul 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Caregivers with a history of depression or other mental illnesses, or those who do not own a smartphone.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Healthy Adults
- Being tested
- Mobile-based Acceptance and Commitment Therapy (ACT) program, Document-based Acceptance and Commitment Therapy (ACT) Program
- Keywords
- mobile app, acceptance and commitment therapy, Randomized Controlled Trial, caregivers, long-term care facilities, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-based Acceptance and Commitment Therapy (ACT) programOther
Participants will complete a daily Acceptance and Commitment Therapy (ACT) session through a mobile application on their smartphones.
Document-based Acceptance and Commitment Therapy (ACT) ProgramOther
Participants will complete a daily Acceptance and Commitment Therapy (ACT) session using materials provided by the research team.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-based ACT group | Experimental | One daily session of the smartphone-based ACT program delivered through the Anzeilax-Plus app Receives: Other: Mobile-based Acceptance and Commitment Therapy (ACT) program |
| Document-based ACT group | Active comparator | One daily session of the document-based ACT program Receives: Other: Document-based Acceptance and Commitment Therapy (ACT) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
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.
Measured: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
Anxiety
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.
Measured: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
Stress
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.
Measured: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
Self-esteem
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
Measured: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
Job burnout
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.
Measured: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
Quality of life (Psychological and physical well-being)
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.
Measured: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start27 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sookmyung Women's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woosang Hwang, Sookmyung Women's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714408
- Sponsor's protocol ID
- SMWU-2604-HR-020-01
- Other IDs
- RS-2026-25477485
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07714408
- Acronym / sponsor ID
- SMWU-2604-HR-020-01
- Conditions
- Healthy Adults
- Keywords
- mobile app, acceptance and commitment therapy, Randomized Controlled Trial, caregivers, long-term care facilities, mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sookmyung Women's UniversityUniversity, hospital or other
- Study start
- 27 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile-based ACT group | Experimental | Other: Mobile-based Acceptance and Commitment Therapy (ACT) programOne daily session of the smartphone-based ACT program delivered through the Anzeilax-Plus app |
| Document-based ACT group | Active comparator | Other: Document-based Acceptance and Commitment Therapy (ACT) ProgramOne daily session of the document-based ACT program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Caregivers with a history of depression or other mental illnesses, or those who do not own a smartphone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile-based Acceptance and Commitment Therapy (ACT) programParticipants will complete a daily Acceptance and Commitment Therapy (ACT) session through a mobile application on their smartphones. | Other | Mobile-based ACT group |
| Document-based Acceptance and Commitment Therapy (ACT) ProgramParticipants will complete a daily Acceptance and Commitment Therapy (ACT) session using materials provided by the research team. | Other | Document-based ACT group |
Primary outcome
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.
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.
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-based Acceptance and Commitment Therapy (ACT) program and Document-based Acceptance and Commitment Therapy (ACT) Program in people with Healthy Adults, run by Sookmyung Women's University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Woosang Hwang, Ph.D. (82-2-2077-7380, woosanghwang@sookmyung.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.