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Recruiting NCT07188467

Testing Adapted Self-Help Plus (SH+) for Stress and Well-Being in International Students at a U.S. University

No phase Interventional Stress, Psychological Depression and/or Anxiety in the Mild-to-moderate Range Loneliness Adjustment, Psychological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digitized SH+.
Who it may be relevant to
Registry conditions: Stress, Psychological, Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness, Adjustment, Psychological. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral Digitized SH+
    Digitized SH+ is a group-based, stress management program (adapted from the original Self-Help Plus intervention developed by the World Health Organization), that utilizes animated videos and group discussions to teach participants skills such as Grounding, Unhooking (from difficult thoughts), Being Kind (to self and others), Identifying Values, and Making Room for Difficult Thoughts and Feelings.

Primary outcome measures

  • Perceived Stress Scale (PSS-10) [Time frame: Change from baseline to 6-week follow-up]
  • Patient Health Questionnaire (PHQ-9) [Time frame: Change from baseline to 6-week follow-up]
  • General Anxiety Disorder (GAD-7) [Time frame: Change from baseline to 6-week follow-up]
Secondary outcome measures (4)
  • Self-Measure for Loneliness (UCLA Loneliness Scale) [Time frame: Change from baseline to 6-week follow-up]
  • Social Support (SSQ) [Time frame: Change from baseline to 6-week follow-up]
  • Self-Efficacy (General Self-Efficacy Scale) [Time frame: Change from baseline to 6-week follow-up]
  • Psychological Adjustment (BASE-6) [Time frame: Change from baseline to 6-week follow-up]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The New School — Brooklyn

Identifiers

NCT: NCT07188467 · SH2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗