Self-Help Plus for Distress in University Students
SSH+
Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress
1 other identifier
interventional
210
1 country
3
Brief Summary
Prrospective, multi-center, randomized controlled trial of a brief, transdiagnostic, guided self-help intervention (Self-Help Plus) for university students who experience significant distress and are behind on their coursework. The intervention will be tested in terms of efficacy and feasibility for outcomes related to distress, anxiety, depression and well-being, assessed immediately after the intervention and at 3-months follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Typical duration for not_applicable
3 active sites
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 11, 2024
CompletedFirst Posted
Study publicly available on registry
September 20, 2024
CompletedStudy Start
First participant enrolled
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 13, 2026
March 1, 2026
1.6 years
September 11, 2024
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Kessler psychological distress scale
The Kessler psychological distress scale (K-10) is a simple measure of psychological distress. It consists of 10 questions about emotional states that can be answered from 1 (none of the time) to 5 (all of the time). Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50.
Baseline, After the intervention, At 3 months after the intervention
Secondary Outcomes (5)
Patient Health Questionnaire-9
Baseline, After the intervention, At 3 months after the intervention
The Generalized Anxiety Disorder-7
Baseline, After the intervention, At 3 months after the intervention
World Health Organization Well-Being Index
Baseline, After the intervention, At 3 months after the intervention
Numbers of exams sustained
Baseline, After the intervention, At 3 months after the intervention
Academic deceit survey
Baseline, After the intervention, At 3 months after the intervention
Other Outcomes (2)
Accesibility
Immediately after the intervention
Intervention dose
Immediately after the intervention
Study Arms (2)
Self-Help Plus (SH+)
EXPERIMENTALThe intervention is available in its individual online self-help version called "Doing What Matters in Time of Stress". It composed of an illustrate guide, divided into sessions, and pre-recorded audio. Participants will be required to access an online platform for attending the sessions. A total of 5 sessions of approximately an hour each are planned. Participants will be guided by facilitators with minimal qualifications and skills in providing psychosocial support. They will receive regular reminders and instructions from helpers at the beginning of the program and before any sessions via phone call, teleconferencing meeting, or message. Facilitators will receive brief training from specialized mental health professionals trained by WHO.
Psychological First Aid (PFA)
ACTIVE COMPARATORPsychological First Aid will also be delivered by facilitators through a phone call or teleconferencing meeting, for an approximate ranging from 20 to 45 minutes. Participants will also receive an information sheet with details about mental health services available for students experiencing distress at each of the centers.
Interventions
Self-Help Plus is a novel, brief, low-intensity intervention, recently developed by the World Health Organization (WHO) and intended to help people with and without mental disorders cope with distress stemming from diverse types of adversity.The key components of the program are based on acceptance and commitment therapy (ACT), a distinct form of cognitive-behavioural therapy. SH+ draws on ACT techniques of coping with stress, compassion and acceptance toward oneself and others, and living following one's values. An online version called "Doing what matters in times of stress" is available as an illustrated guide and pre-recorded audio.
Psychological First Aid (PFA) is also developed by the WHO and is a general supportive intervention, aimed at listening and understanding the needs and concerns of people, providing support without pressuring them to talk.
Eligibility Criteria
You may qualify if:
- University students across all years of higher education (i.e., bachelor and masters), enrolled in any degree course, starting from the second semester of the 1st year
- Currently behind coursework by at least 3 exams, including: exams failed, for which the obtained grade was not confirmed by the student (i.e., confirming the grade is mandatory in the Italian academic system), or postponed (i.e., not taken in the regularly scheduled period).
- Experience significant distress as assessed by the Kessler psychological distress scale (K-10) ≥ 16.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Padovalead
- Universita di Veronacollaborator
- University of Bari Aldo Morocollaborator
Study Sites (3)
University of Bari "Aldo Moro"
Bari, Bari, 70121, Italy
University of Padova
Padua, 35131, Italy
Universita di Verona
Verona, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ioana Cristea, PhD
University of Padova
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The three site investigators will not be made aware of the block size or have any access to the randomization schedule. The software allows for random allocation of participants after the baseline evaluation is performed and inclusion criteria are checked. The study statistician will also be blinded to group allocation.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 11, 2024
First Posted
September 20, 2024
Study Start
March 10, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- One year after study completion.
- Access Criteria
- Interested parties will have to submit a data request including as a minimum the purpose of accessing the data, how the data will be used and how findings will be disseminated. A data sharing agreement will be signed between the requestor and principal investigator underlying the purposes and conditions for which data will be used.
Fully anonymized and de-identified individual participant data will be made available, following a request and the signing of a data sharing agreement, completed by the data requestor and directed to the principal investigator. Complete metadata and analysis scripts will be made publicly available with each publication. Individual participant data will be made available for research purposes only, including replication. The data will not be made available for non-research purposes in accordance with the legal framework underpinning ethical approval and informed consent.