Mindfulness Intervention for Maltreatment-Related Cognitive Decline

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?

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 Overview

• Status: Active, not recruiting
• Conditions: Health Adult Subjects; Maltreament
• Intervention / Treatment: Behavioral: Mindfulness-Based Online Training Program

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Kyungpook National University Chilgok Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm - Mindfulness Intervention Group; Participants receive a 4-week online mindfulness-based training via a structured website (videos, weekly tasks).; Includes breathing, body scan, and walking meditation sessions	Behavioral: Mindfulness-Based Online Training Program; 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 weekOptional support via KakaoTalk channel for Q&A and participant engagement; Weekly themes include:Breathing and muscle relaxationMindfulness breathing meditationBody scan meditationMindful walking
No Intervention: Control Arm - Waiting List Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function_self-report	Conner's Adult ADHD Rating Scale Korean Version (CAARS-K)	Baseline and after 4 weeks
Cognitive function_Computerized	Comprehensive Attention Test	Baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Center for Epidemiologic Studies Depression Scale	Baseline and after 4 weeks
Anxiety Symptoms	Generalized Anxiety Disorder-7	Baseline and after 4 weeks
Emotional Regulation Difficulties	Difficulties in Emotion Regulation Scale	Baseline and after 4 weeks
Cognitive Emotion Regulation Strategy	Cognitive Emotion Regulation Questionnaire	Baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: Kyungpook National University Chilgok Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: July 4, 2025
• First Submitted That Met QC Criteria: July 4, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive Function; Childhood Maltreatment; Mindfulness-Based Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2025-05-020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No