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

Not Applicable

Recruiting

• Conditions: Stress, Psychological; Depression and/or Anxiety in the Mild-to-moderate Range; Loneliness; Adjustment, Psychological

• Registration Number: NCT07188467
• Lead Sponsor: The New School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Study First Posted: 2025-09-23
• Status Verified: 2025-10
• Study Start: 2025-10-07
• Last Update Submitted: 2025-10-07
• Last Update Posted: 2025-10-09
• Primary Completion: 2025-12
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS-10)	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)	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)	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

Secondary Outcome Measures

Name	Time	Method
Social Support (SSQ)	Change from baseline to 6-week follow-up	Range varies (depends on individual): self-reported number of people available for support + satisfaction rating).; Higher scores = better outcome (greater perceived support and satisfaction).
Psychological Adjustment (BASE-6)	Change from baseline to 6-week follow-up	Range: 6-42 (six items, each scored 1-7). Higher scores = worse outcome (greater emotional distress and adjustment difficulty).
Self-Measure for Loneliness (UCLA Loneliness Scale)	Change from baseline to 6-week follow-up	Range: 0-60 (20 items, scored 0-3) Higher scores = worse outcome (greater loneliness/social isolation).
Self-Efficacy (General Self-Efficacy Scale)	Change from baseline to 6-week follow-up	Range: 10-40 (10 items, scored 1-4). Higher scores = better outcome (greater self-efficacy/confidence in coping).

Trial Locations

Locations (1)

The New School; 🇺🇸 Brooklyn, New York, United States