NCT07188467

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 7, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

2 months

First QC Date

September 16, 2025

Last Update Submit

October 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Perceived Stress Scale (PSS-10)

    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

    Change from baseline to 6-week follow-up

  • Patient Health Questionnaire (PHQ-9)

    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.

    Change from baseline to 6-week follow-up

  • General Anxiety Disorder (GAD-7)

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

    Change from baseline to 6-week follow-up

Secondary Outcomes (4)

  • 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

Study Arms (1)

Self-Help Plus (SH+) Workshop

EXPERIMENTAL

Participants will attend a two-day in-person workshop featuring digitized SH+ materials. The workshop includes animated videos, guided stress management exercises, and group discussions.

Behavioral: Digitized SH+

Interventions

Digitized SH+BEHAVIORAL

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.

Self-Help Plus (SH+) Workshop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New School

Brooklyn, New York, 10011, United States

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Adam D Brown, PhD

    The New School, Center for Global Mental Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josheka S Chauhan, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 23, 2025

Study Start

October 7, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations