Clinical trial NCT06166693: The Effectiveness of the "MINDLiNG" Digital Mental Health Intervention
Official title: A Randomized Controlled Trial of a Personality Trait-focused Digital Mental Health Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Services
Personality
Keywords: digital mental health service
intervention
randomized controlled trial
Personality Focused
Lead sponsor: 40FY
Sponsor class: INDUSTRY
Collaborators: name: The Ministry of SMEs and Startups. South Korea
First posted: 2023-12-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
measure: Hewitt Multidimensional Perfectionism Scale
timeFrame: The Riggy treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
measure: State Self-Esteem Scale
timeFrame: The Pleaser treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
measure: UCLA Loneliness Scale
timeFrame: The Shelly treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
measure: Beck Anxiety Inventory (BAI)
timeFrame: 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:
measure: Self-Efficacy Stress (SES)
timeFrame: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
measure: State-Trait Anxiety Inventory (STAI) trait
timeFrame: The treatment group was assessed at Weeks 0, 5, 10, and 14, and the waitlist group at Weeks 0, 5, and 10
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine, Department of Psychiatry
name: Min-Sup Shin, PhD
role: PRINCIPAL_INVESTIGATOR
References: