跳至主要内容
临床试验/NCT07188467
NCT07188467招募中不适用

Implementing a Scalable Mental Health Intervention for International Students: A Pilot Study of Digitized Self-Help Plus

The New School2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月7日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Perceived Stress Scale (PSS-10)

研究概览

简要总结

The goal of this clinical trial is to learn if an adapted version of Self-Help Plus (SH+), a stress management program developed by the World Health Organization, can reduce stress and improve well-being in international students at a U.S. university. The main questions it aims to answer are:

Does SH+ reduce perceived stress, anxiety, and depressive symptoms in international students? Does SH+ improve feelings of social support, self-efficacy, and adjustment in a new cultural environment?

Participants will:

Attend a two-day in-person workshop that includes animated videos, interactive activities, and group discussions.

Complete three surveys (before the workshop, right after, and six weeks later) about stress, mood, and well-being.

Optionally, take part in a short interview to share feedback about their experience.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Enrolled as an international student at The New School
  • Age 18 years or older
  • Willing to provide informed consent and complete study assessments
  • Score of ≥3 on the PHQ-4, indicating at least mild distress
  • Sufficient English proficiency to comprehend intervention materials

排除标准

  • Severe psychiatric conditions requiring immediate intervention (e.g., active psychosis, severe mood disorders)
  • Visual, hearing, or neurocognitive impairments that prevent engagement with the intervention
  • Having an advanced degree in psychology or mental health-related fields (to prevent prior knowledge bias)
  • Score of 2 or higher on PHQ-4 Item 3 or Item 4 (frequent thoughts of self-harm or severe distress)

结局指标

主要结局

Perceived Stress Scale (PSS-10)

时间窗: Change from baseline to 6-week follow-up

Self-reported perceived stress levels. Higher scores indicate greater perceived stress. Range: 0-40 Higher scores= worse outcome (greater perceived stress) Cutoffs: 0-13 low, 14-26 moderate, 27-40 high

Patient Health Questionnaire (PHQ-9)

时间窗: Change from baseline to 6-week follow-up

Range: 0-27 Higher scores = worse outcome (greater depression severity). Cutoffs: 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

General Anxiety Disorder (GAD-7)

时间窗: Change from baseline to 6-week follow-up

Range: 0-21 Higher scores = worse outcome (greater anxiety severity) Cutoffs: 0-4 minimal, 5-9 mild, 10-14 moderate, 15-21 severe

Perceived Stress Scale (PSS-10)

时间窗: Change from baseline to 6-week follow-up

Self-reported perceived stress levels. Higher scores indicate greater perceived stress. Range: 0-40 Higher scores= worse outcome (greater perceived stress) Cutoffs: 0-13 low, 14-26 moderate, 27-40 high

Patient Health Questionnaire (PHQ-9)

时间窗: Change from baseline to 6-week follow-up

Range: 0-27 Higher scores = worse outcome (greater depression severity). Cutoffs: 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

General Anxiety Disorder (GAD-7)

时间窗: Change from baseline to 6-week follow-up

Range: 0-21 Higher scores = worse outcome (greater anxiety severity) Cutoffs: 0-4 minimal, 5-9 mild, 10-14 moderate, 15-21 severe

次要结局

  • Social Support (SSQ)(Change from baseline to 6-week follow-up)
  • Psychological Adjustment (BASE-6)(Change from baseline to 6-week follow-up)
  • Self-Measure for Loneliness (UCLA Loneliness Scale)(Change from baseline to 6-week follow-up)
  • Self-Efficacy (General Self-Efficacy Scale)(Change from baseline to 6-week follow-up)
  • Self-Measure for Loneliness (UCLA Loneliness Scale)(Change from baseline to 6-week follow-up)
  • Social Support (SSQ)(Change from baseline to 6-week follow-up)
  • Self-Efficacy (General Self-Efficacy Scale)(Change from baseline to 6-week follow-up)
  • Psychological Adjustment (BASE-6)(Change from baseline to 6-week follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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