Stress, PsychologicalNCT07188467
Testing Adapted Self-Help Plus (SH+) for Stress and Well-Being in International Students at a U.S. University
A study testing Digitized SH+ in people with Stress, Psychological and Depression and/or Anxiety in the Mild-to-moderate Range, run by The New School at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness
- What is being tested?
- Digitized SH+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The New School
Brooklyn, New York, 10011
Josheka Chauhan, 3473072179, chauj265@newschool.edu
Adam D. Brown, PhD
About this study
Official title: Implementing a Scalable Mental Health Intervention for International Students: A Pilot Study of Digitized Self-Help Plus
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?
Read more
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.
- Conditions
- Stress, Psychological, Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness, Adjustment, Psychological
- Being tested
- Digitized SH+
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitized SH+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digitized SH+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: Change from baseline to 6-week follow-up
Secondary outcomes (4)
Self-Measure for Loneliness (UCLA Loneliness Scale)
Range: 0-60 (20 items, scored 0-3) Higher scores = worse outcome (greater loneliness/social isolation).
Measured: Change from baseline to 6-week follow-up
Social Support (SSQ)
Range varies (depends on individual): self-reported number of people available for support + satisfaction rating).
Higher scores = better outcome (greater perceived support and satisfaction).
Measured: Change from baseline to 6-week follow-up
Self-Efficacy (General Self-Efficacy Scale)
Range: 10-40 (10 items, scored 1-4). Higher scores = better outcome (greater self-efficacy/confidence in coping).
Measured: Change from baseline to 6-week follow-up
Psychological Adjustment (BASE-6)
Range: 6-42 (six items, each scored 1-7). Higher scores = worse outcome (greater emotional distress and adjustment difficulty).
Measured: Change from baseline to 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start7 Oct 2025
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam D Brown, PhD, Principal investigator, The New School, Center for Global Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188467
- Sponsor's protocol ID
- SH2025-001
- Status last verified
- Oct 2025
- First submitted
- 16 Sep 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Scalable Mental Health Intervention for International Students: A Pilot Study of Digitized Self-Help Plus
- ClinicalTrials.gov ID
- NCT07188467
- Acronym / sponsor ID
- SH2025-001
- Conditions
- Stress, Psychological, Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness, Adjustment, Psychological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The New SchoolUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-Help Plus (SH+) Workshop | Experimental | Behavioral: Digitized SH+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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Self-Help Plus (SH+) Workshop |
Primary outcome
Perceived Stress Scale (PSS-10)
Time frame: 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)
Time frame: 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)
Time frame: 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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam D Brown, PhD principal investigator
The New School, Center for Global Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitized SH+ in people with Stress, Psychological and Depression and/or Anxiety in the Mild-to-moderate Range, run by The New School at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josheka S Chauhan, MA (347-307-2179, chauj265@newschool.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: Change from baseline to 6-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.