The Effectiveness of the "MINDLiNG" Digital Mental Health Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Personality; Mental Health Services
• Intervention / Treatment: Device: "MINDLiNG" Digital Mental Health Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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; 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
No Intervention: Waitlist group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10

Collaborators and Investigators

• Sponsor: 40FY
• Collaborators: The Ministry of SMEs and Startups. South Korea
• Investigators: Principal Investigator: Min-Sup Shin, PhD, Seoul National University College of Medicine, Department of Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; intervention; digital mental health service; Personality Focused
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders
• Other Study ID Numbers: SNUH_MINDLiNG_RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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