Mindfulness Intervention for Maltreatment-Related Cognitive Decline

NCT07066800 | Active Not Recruiting

• 1 other identifier: 2025-05-020-001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Health Adult Subjects; Maltreament

Keywords

Mindfulness-Based Intervention; Cognitive Function; Childhood Maltreatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Depressive Symptoms

  Baseline and after 4 weeks

• Anxiety Symptoms

  Baseline and after 4 weeks

• Emotional Regulation Difficulties

  Baseline and after 4 weeks

• Cognitive Emotion Regulation Strategy

  Baseline and after 4 weeks

Study Arms (2)

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

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).

Interventions

Mindfulness-Based Online Training Program BEHAVIORAL

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

Experimental Arm - Mindfulness Intervention Group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kyungpook National University Chilgok Hospital: lead

Study Sites (1)

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: June 27, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)