Health Adult SubjectsNCT07066800
Mindfulness Intervention for Maltreatment-Related Cognitive Decline
A study testing Mindfulness-Based Online Training Program in people with Health Adult Subjects and Maltreament, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to examine whether an online mindfulness-based training program can help improve cognitive function including attention, emotional regulation, and mental health (such as depression and anxiety) in young adults (ages 19 to 40) who have experienced maltreatment. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects, Maltreament
- What is being tested?
- Mindfulness-Based Online Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 19 to 40 years
- Individuals with a history of childhood maltreatment, defined as meeting at least one of the following on the Early Trauma Inventory-Short Form (ETISR-SF)
- At least one subscale (general trauma, physical abuse, emotional abuse, sexual abuse) exceeding established cut-off scores (Plaza et al., 2011)
- A Global score ≥ 4 on ETISR-SF
- No current or past history of major internal medical or psychiatric disorders
- Willing and able to provide written informed consent
- Able to access and use an online platform (computer or mobile device)
Who cannot join
- Intellectual disability, defined as IQ ≤ 70
- History of traumatic brain injury
- Ongoing or past (≥6 months) psychiatric treatment for a diagnosed mental disorder
- Presence of severe psychiatric symptoms impairing reality testing or basic daily functioning (Note: Individuals with mild to moderate depressive symptoms based on screening are not excluded)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verification of the Effects of a Mindfulness-based Online Training Program for Recovering From Cognitive Decline Related to Maltreatment Experiences
The goal of this clinical trial is to examine whether an online mindfulness-based training program can help improve cognitive function including attention, emotional regulation, and mental health (such as depression and anxiety) in young adults (ages 19 to 40) who have experienced maltreatment. The main questions it aims to answer are:
- Can a 4-week online mindfulness program improve cognitive function including attention in adults with a history of maltreatment?
- Does the program reduce symptoms of depression and anxiety compared to a control group?
Read more
Researchers will compare a mindfulness training group with a waiting-list control group to see if the intervention leads to improvements in psychological and cognitive functioning.
Participants will:
- Complete psychological and cognitive assessments before and after the 4-week period
- Watch weekly online educational and mindfulness practice videos (e.g., breathing, body scan, walking meditation)
- Perform weekly mindfulness-based assignments through a study website
- Engage in optional interaction via a chat channel
- Conditions
- Health Adult Subjects, Maltreament
- Being tested
- Mindfulness-Based Online Training Program
- Keywords
- Mindfulness-Based Intervention, Cognitive Function, Childhood Maltreatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Online Training ProgramBehavioural
A 4-week web-based mindfulness program developed by the research team, designed to improve attention, emotional regulation, and mental health in adults with a history of maltreatment.
- The intervention includes:
- Weekly educational videos (5-10 minutes each)
- Weekly mindfulness practice videos (5-10 minutes each)
- Assigned home practices each week
- Optional support via KakaoTalk channel for Q\&A and participant engagement
- Weekly themes include:
- Breathing and muscle relaxation
- Mindfulness breathing meditation
- Body scan meditation
- Mindful walking
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm - Mindfulness Intervention Group | Experimental | * Participants receive a 4-week online mindfulness-based training via a structured website (videos, weekly tasks).
* Includes breathing, body scan, and walking meditation sessions Receives: Behavioral: Mindfulness-Based Online Training Program |
| Control Arm - Waiting List Group | No intervention | * Participants do not receive the intervention during the initial 4 weeks. * Serve as a comparison group for pre-post outcomes. * May receive the intervention after the study period (if planned as ethical compensation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Emotion Regulation Strategy
Cognitive Emotion Regulation Questionnaire
Measured: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Emotional Regulation Difficulties
Difficulties in Emotion Regulation Scale
Measured: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Cognitive function_Computerized
Comprehensive Attention Test
Measured: Baseline and 4 weeks (Intervention group); 4 weeks, and 8 weeks (Waitlist control group)
Cognitive function_self-report
Conner's Adult ADHD Rating Scale Korean Version (CAARS-K)
Measured: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Secondary outcomes (2)
Depressive Symptoms
Center for Epidemiologic Studies Depression Scale
Measured: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Anxiety Symptoms
Generalized Anxiety Disorder-7
Measured: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start27 Jun 2025
- Primary completion28 Feb 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Won Lee, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066800
- Sponsor's protocol ID
- 2025-05-020-001
- Status last verified
- Oct 2026
- First submitted
- 4 Jul 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes may be shared following study completion and publication of results, but only upon formal request and at the discretion of the principal investigator. Access will be granted solely for non-commercial academic research purposes and will require a data use agreement and institutional approval.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of the Effects of a Mindfulness-based Online Training Program for Recovering From Cognitive Decline Related to Maltreatment Experiences
- ClinicalTrials.gov ID
- NCT07066800
- Acronym / sponsor ID
- 2025-05-020-001
- Conditions
- Health Adult Subjects, Maltreament
- Keywords
- Mindfulness-Based Intervention, Cognitive Function, Childhood Maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 15 Jul 2025 (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 goal of this clinical trial is to examine whether an online mindfulness-based training program can help improve cognitive function including attention, emotional regulation, and mental health (such as depression and anxiety) in young adults (ages 19 to 40) who have experienced maltreatment. The main questions it aims to answer are:
- Can a 4-week online mindfulness program improve cognitive function including attention in adults with a history of maltreatment?
- Does the program reduce symptoms of depression and anxiety compared to a control group?
Researchers will compare a mindfulness training group with a waiting-list control group to see if the intervention leads to improvements in psychological and cognitive functioning.
Participants will:
- Complete psychological and cognitive assessments before and after the 4-week period
- Watch weekly online educational and mindfulness practice videos (e.g., breathing, body scan, walking meditation)
- Perform weekly mindfulness-based assignments through a study website
- Engage in optional interaction via a chat channel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm - Mindfulness Intervention Group | Experimental | Behavioral: Mindfulness-Based Online Training Program* Participants receive a 4-week online mindfulness-based training via a structured website (videos, weekly tasks). * Includes breathing, body scan, and walking meditation sessions |
| Control Arm - Waiting List Group | No intervention | –* Participants do not receive the intervention during the initial 4 weeks. * Serve as a comparison group for pre-post outcomes. * May receive the intervention after the study period (if planned as ethical compensation). |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 19 to 40 years
- Individuals with a history of childhood maltreatment, defined as meeting at least one of the following on the Early Trauma Inventory-Short Form (ETISR-SF)
- No current or past history of major internal medical or psychiatric disorders
- Willing and able to provide written informed consent
- Able to access and use an online platform (computer or mobile device)
Key exclusion criteria (4 listed)
- Intellectual disability, defined as IQ ≤ 70
- History of traumatic brain injury
- Ongoing or past (≥6 months) psychiatric treatment for a diagnosed mental disorder
- Presence of severe psychiatric symptoms impairing reality testing or basic daily functioning (Note: Individuals with mild to moderate depressive symptoms based on screening are not excluded)
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 |
|---|---|---|
| Mindfulness-Based Online Training ProgramA 4-week web-based mindfulness program developed by the research team, designed to improve attention, emotional regulation, and mental health in adults with a history of maltreatment. * The intervention includes: * Weekly educational videos (5-10 minutes each) * Weekly mindfulness practice videos (5-10 minutes each) * Assigned home practices each week * Optional support via KakaoTalk channel for Q\&A and participant engagement * Weekly themes include: * Breathing and muscle relaxation * Mindfulness breathing meditation * Body scan meditation * Mindful walking | Behavioural | Experimental Arm - Mindfulness Intervention Group |
Primary outcome
Cognitive Emotion Regulation Strategy
Time frame: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Cognitive Emotion Regulation Questionnaire
Emotional Regulation Difficulties
Time frame: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Difficulties in Emotion Regulation Scale
Cognitive function_Computerized
Time frame: Baseline and 4 weeks (Intervention group); 4 weeks, and 8 weeks (Waitlist control group)
Comprehensive Attention Test
Cognitive function_self-report
Time frame: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Conner's Adult ADHD Rating Scale Korean Version (CAARS-K)
2 secondary outcomes
Depressive Symptoms
Time frame: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Anxiety Symptoms
Time frame: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes may be shared following study completion and publication of results, but only upon formal request and at the discretion of the principal investigator. Access will be granted solely for non-commercial academic research purposes and will require a data use agreement and institutional approval.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Online Training Program in people with Health Adult Subjects and Maltreament, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Emotion Regulation Strategy (time frame: Baseline and 4 weeks (Intervention group); Baseline, 4 weeks, and 8 weeks (Waitlist control group)). The study lists 4 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 14 Oct 2026.