Mental Health ServicesNCT06166693

The Effectiveness of the "MINDLiNG" Digital Mental Health Intervention

A study testing "MINDLiNG" Digital Mental Health Intervention in people with Mental Health Services and Personality, run by 40FY at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Mental Health Services, Personality
What is being tested?: "MINDLiNG" Digital Mental Health Intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteSouth Korea
Study dates: 23 Nov 2022to 31 May 2023
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

In cases where there is difficulty understanding and reading Korean.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized Controlled Trial of a Personality Trait-focused Digital Mental Health Intervention

Read the detailed description

This study conducted a randomized controlled trial to evaluate the effectiveness of a digital intervention program called "MINDLiNG" designed to target maladaptive personality traits, with four subprograms addressing perfectionism, low self-esteem, social isolation, and anxiety. Participants were assigned to one of these programs, and primary outcome measures varied accordingly, including the Perceived Stress Scale, Hewitt Multidimensional Perfectionism Scale, State Self-Esteem Scale, UCLA Loneliness Scale, and Beck Anxiety Inventory. The study anticipated treatment effects in both primary and secondary outcome measures for the treatment group compared to the waitlist group after 5 and 10 weeks of intervention.

Conditions: Mental Health Services, Personality
Being tested: "MINDLiNG" Digital Mental Health Intervention
Keywords: digital mental health service, intervention, randomized controlled trial, Personality Focused

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"MINDLiNG" Digital Mental Health InterventionDevice
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

Study groups in NCT06166693
Study group	Role	What they receive
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). Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
A measure for entirety of the MINDLiNG program. The SES is a 23-item scale that assesses the individuals self-efficacy on a 5-point likert scale ranging from 23 to 115. Higher scores indicate higher level of self-efficacy.
Measured: 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)
A measure for entirety of the MINDLiNG program. The CES-D is a 20-item questionnaire that measures depressive symptoms on a 4-point likert scale ranging from 0 to 60. Higher score means higher level of depression.
Measured: 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
A measure for entirety of the MINDLiNG program. The STAI trait is a 20-item inventory that measures trait anxiety on a 4-point likert scale ranging from 20 to 80. Higher score means higher anxiety.
Measured: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 202231 May 2023

First posted12 Dec 2023
Study start23 Nov 2022
Primary completion31 May 2023
Study completion31 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mental Health ServicesStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06166693
Sponsor's protocol ID: SNUH_MINDLiNG_RCT
Status last verified: Dec 2023
First submitted: 4 Dec 2023
Last updated: 15 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40574385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of a Personality Trait-focused Digital Mental Health Intervention
ClinicalTrials.gov ID: NCT06166693
Acronym / sponsor ID: SNUH_MINDLiNG_RCT
Conditions: Mental Health Services, Personality
Keywords: digital mental health service, intervention, randomized controlled trial, Personality Focused
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: 40FYIndustry (pharma, biotech, devices)
Collaborators: The Ministry of SMEs and Startups. South Korea
Study start: 23 Nov 2022 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 12 Dec 2023 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Treatment group	Experimental	Device: "MINDLiNG" Digital Mental Health InterventionAdults 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).
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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

In cases where there is difficulty understanding and reading Korean.

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
"MINDLiNG" Digital Mental Health InterventionThe 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	Device	Treatment group

Primary outcome

Perceived Stress Scale
Time frame: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
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.
Hewitt Multidimensional Perfectionism Scale
Time frame: The Riggy treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
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.
State Self-Esteem Scale
Time frame: The Pleaser treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
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.
UCLA Loneliness Scale
Time frame: The Shelly treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
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.
Beck Anxiety Inventory (BAI)
Time frame: The Jumpy treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
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

3 secondary outcomes

Self-Efficacy Stress (SES)
Time frame: 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)
Time frame: 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
Time frame: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

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 15 Dec 2023.
Derived from this study: PubMed 40574385Jeong 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.
Individual participant dataSharing planned: No

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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.

Min-Sup Shin, PhD principal investigator

Seoul National University College of Medicine, Department of Psychiatry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing "MINDLiNG" Digital Mental Health Intervention in people with Mental Health Services and Personality, run by 40FY 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 2 inclusion and 1 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 15 Dec 2023. 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?

Perceived Stress Scale (time frame: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166693, which also lists 1 linked publication.

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 15 Dec 2023.