The Effectiveness of the "MINDLiNG" Digital Mental Health Intervention

Personality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06166693
• Other study ID #: SNUH_MINDLiNG_RCT
• Status: Completed
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2023
• Source: 40FY
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The study highlights the potential of digital solutions to address the high demand for mental healthcare services in South Korea.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Services
• Personality
• Personality Disorders

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
40FY	The Ministry of SMEs and Startups. South Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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