| Registry | NCT07123311 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 148 (Actual) |
| Sponsor | University of Sfax (Other) |
| Conditions | Anxiety Depression (Mild or Not Persistent) |
| Interventions | Online Stress Management Program (Behavioral) |
| Dates | start 2025-09-15, primary completion 2025-12-14, completion 2026-07-15 (estimated), first posted 2025-08-14, last updated 2026-06-29 |
| Locations | 1 site in Tunisia |
Related Papers Related Patents Related Grants Related Experts
All trials for Anxiety Depression (Mild or Not Persistent) All trials of Online Stress Management Program
The objective of this experimental study (randomized controlled trial) is to evaluate the effectiveness of an internet-based stress management program, inspired by the French program "Je gère mon stress," among healthcare students in Sfax, Tunisia.
The target population includes all healthcare students over 18 years old, from any field (paramedical, nursing, medicine, etc.), regardless of their baseline level of perceived stress.
The main questions this study aims to answer are:
Does the online program significantly reduce the level of perceived stress (measured using the Perceived Stress Scale - PSS-10)? Does the program have a beneficial impact on symptoms of anxiety and depression (measured with the Hospital Anxiety and Depression Scale - HADS)? Does it improve sleep quality (assessed using the Pittsburgh Sleep Quality Index - PSQI)?
Comparison group:
Researchers will compare the outcomes of the intervention group (who will access the online stress management program for 8 weeks) with those of the control group (waiting list, no initial access), to evaluate the specific effects of the program.
Participants will:
Complete three validated questionnaires (PSS-10, HADS, and PSQI) before and after the intervention; Be invited to follow a weekly series of psychoeducational modules over 8 weeks, including short educational videos, breathing techniques, guided relaxation, and practical exercises, all accessible through a secure web platform; Receive weekly motivational messages to support engagement.
This randomized controlled trial aims to assess the effectiveness of an internet-based stress management program tailored for healthcare students in Sfax, Tunisia. The intervention is an adaptation of the validated French program "Je gère mon stress," redesigned to fit the local sociocultural context.
The study targets healthcare students aged 18 and above, from various disciplines (nursing, physiotherapy, midwifery, anesthesia, etc.), regardless of their baseline perceived stress levels.
Participants in the intervention group will receive access to an 8-week structured online program composed of:
Weekly psychoeducational video capsules (covering stress mechanisms, coping strategies, relaxation techniques, etc.), Guided breathing and relaxation exercises, Simple cognitive-behavioral tools, Time management and lifestyle advice.
All participants will be assessed at baseline (pre-intervention) and post-intervention using three validated instruments:
PSS-10 (Perceived Stress Scale) to evaluate perceived stress, HADS (Hospital Anxiety and Depression Scale) to assess symptoms of anxiety and depression, PSQI (Pittsburgh Sleep Quality Index) to measure sleep quality. A control group will not receive any intervention during the 8-week period but will be offered the program after the study ends (waiting list design). This design allows a fair comparison between groups and ensures ethical access to the intervention.
The program is fully accessible online via a secure platform and requires no in-person attendance. Participants will receive weekly reminders to complete the sessions and questionnaires.
The main outcome is the change in perceived stress levels. Secondary outcomes include changes in anxiety, depression, and sleep quality.
This study contributes to addressing the high psychological burden observed in healthcare students in Tunisia and promotes the use of digital tools for mental health support in academic settings.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Groupe I | Experimental | Behavioral: Online Stress Management Program | Participants in the intervention group will receive an email containing their login credentials (username and password) to access the website and actively participate in the scheduled sessions of the program. Upon logging in, they will watch a short introductory video of about five minutes explaining how the program works. They will then answer three follow-up questions to confirm their understanding. If any answers are incorrect, they will be asked to rewatch the video until all questions are correctly answered. Next, participants will receive an information letter explaining the requirement to visit the website at least once a week for a minimum of 30 minutes per session, with the option to spend more time or visit more frequently if they wish. After successfully answering the questions, they will be asked to provide informed consent ensuring the security and confidentiality of their personal data before accessing the sessions. This initial step is crucial for the success of the p |
| Groupe C | No intervention | Participants in the control group will receive an email informing them of their assignment. They will have access to the website after 12 weeks. They will be asked to refrain from any stress management activities (such as yoga, meditation, etc.) during this period. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * The target population includes all students enrolled in the third year at the Higher Institute of Nursing Sciences (ISSIS) and the Higher School of Health Sciences and Techniques (ESSTSS) for the 2025-2026 academic year. * Own a smartphone, tablet, or computer. * Have internet access. * Have an email address. * Be willing to be randomized. * Have given informed consent to participate in the study. * Be available and committed to completing the entire online intervention program and participating in all evaluations. Exclusion Criteria: * Current enrollment in another stress management program; * History of chronic psychiatric illness; * Current use of anxiolytic or psychotropic medication.
| Facility | City | Country | Status |
|---|---|---|---|
| Faculties of Sealth Sciences | Sfax | Tunisia |