Mindfulness Intervention for Maltreatment-Related Cognitive Decline

NCT ID: NCT07066800

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2027-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Mindfulness-Based Online Training Program

Intervention Type: 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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Won Lee

M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Countries

South Korea

Other Identifiers

2025-05-020-001

Identifier Type: -

Identifier Source: org_study_id