NCT06166693

Brief Summary

A study in South Korea assessed the effectiveness of the "MINDLiNG" digital mental healthcare program, targeting maladaptive personality traits, and found significant improvements in reducing stress, perfectionism, loneliness, and anxiety, while increasing self-esteem among participants. The study highlights the potential of digital solutions to address the high demand for mental healthcare services in South Korea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

December 4, 2023

Last Update Submit

December 11, 2023

Conditions

Keywords

digital mental health serviceinterventionrandomized controlled trialPersonality Focused

Outcome Measures

Primary Outcomes (5)

  • Perceived Stress Scale

    The primary outcome measure for the entirety of the MINDLiNG program. The Perceived Stress Scale (PSS) is a 10-item scale that can range from 0 to 40, which measures the perceived stress on a 5-point severity with higher scores indicating more severe perceived stress.

    The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

  • Hewitt Multidimensional Perfectionism Scale

    Perfectionism, the primary outcome of the Riggy program, was measured using the Hewitt Multidimensional Perfectionism Scale (HMPS). The HMPS is a 45-item measure with three trait subscales measuring self-oriented perfectionism, other-oriented perfectionism, and socially prescribed perfectionism. It ranges from 45 to 315. Higher level means higher level of perfectionism.

    The Riggy treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

  • State Self-Esteem Scale

    State self-esteem, the primary outcome of the Pleaser program, was measured using the Sate Self-Esteem Scale (SSES) SSES is a 20-item scale on a 5-point likert scale ranging from 20 to 100, assessing 3 facets of self-esteem: appearance, performance, and social. Higher score means higher level of self-esteem.

    The Pleaser treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

  • UCLA Loneliness Scale

    Loneliness, the primary outcome of the Shelly program, was measured using the UCLA Loneliness Scale (UCLA-LS). UCLA-LS is a 20-item scale to measure subjective feelings of loneliness as well as feelings of social isolation on a 4-point likert scale ranging from 20 to 80. Higher score means higher level of loneliness.

    The Shelly treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

  • Beck Anxiety Inventory (BAI)

    The primary measure of the Jumpy program was the BAI. A 21-item self-inventory on a 4-point likert scale ranging from 0 to 63, measuring common somatic and cognitive symptoms of anxiety. Higher score means higher level of anxiety

    The Jumpy treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

Secondary Outcomes (3)

  • Self-Efficacy Stress (SES)

    The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

  • Center for Epidemiologic Studies Depression Scale (CES-D)

    The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

  • State-Trait Anxiety Inventory (STAI) trait

    The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

Study Arms (2)

Treatment group

EXPERIMENTAL

Adults between the ages of 18 and 60 were recruited and randomly assigned to the treatment group and waitlist group in the ratio of 2:1. Based on the screening results, 75 participants were assigned to each of the four intervention programs within MINDLiNG (Riggy, Pleaser, Shelly, and Jumpy).

Device: "MINDLiNG" Digital Mental Health Intervention

Waitlist group

NO INTERVENTION

Adults between the ages of 18 and 60 were recruited and randomly assigned to the treatment group and waitlist group in the ratio of 2:1. Based on the screening results, 25 participants were assigned to each of the four intervention programs waitlist.

Interventions

The intervention was delivered on an online platform set up separately for the study, which was accessible via the web browser and application. The psychological intervention program for maladaptive personality traits (Mindling) is based on the principles of CBT, psychological schema therapy, acceptance-commitment therapy, and mindfulness-based cognitive therapy, and is aimed primarily at adults to prevent and overcome psychological difficulties

Treatment group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults between the ages of 18 and 60
  • Experiencing a moderate level of stress in their daily lives (PSS≥17) and meet a certain level of perfectionism (HMPS≥198), self-esteem (SSES≤57), loneliness (UCLA LS≥47), and anxiety (BAI≥16). The cutoff points for each scale are based on the top or bottom 25% of the frequency distribution suggested in the previous study.

You may not qualify if:

  • In cases where there is difficulty understanding and reading Korean.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Jeong S, Kim H, Lho SK, Hwang I, Mun S, Kim S, Lim H, Kim H, Shin MS, Moon W. Schema-Informed Digital Mental Health Intervention for Maladaptive Cognitive-Emotional Patterns: Randomized Controlled Trial. J Med Internet Res. 2025 Aug 14;27:e65892. doi: 10.2196/65892.

Study Officials

  • Min-Sup Shin, PhD

    Seoul National University College of Medicine, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

November 23, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations