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临床试验/NCT06166693
NCT06166693已完成不适用

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

40FY1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Perceived Stress Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Perceived Stress Scale

时间窗: 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.

UCLA Loneliness Scale

时间窗: 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.

Hewitt Multidimensional Perfectionism Scale

时间窗: 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

时间窗: 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.

Beck Anxiety Inventory (BAI)

时间窗: 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

次要结局

  • 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)
  • 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)
  • 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)

研究者

发起方
40FY
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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