Implementation and Evaluation of an Internet-Based Stress Management Program for Health Students in the Sfax Region

Not Applicable

Not yet recruiting

• Conditions: Anxiety Depression (Mild or Not Persistent)

• Registration Number: NCT07123311
• Lead Sponsor: University of Sfax

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-15
• Primary Completion: 2025-11-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• The target population includes all students enrolled in the second 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

• The study does not have any specific a priori exclusion criteria. However, participants will be excluded from the analysis in the following cases:

Voluntary withdrawal: any participant wishing to stop their participation may do so at any time; Incomplete data: data that do not allow for reliable statistical analysis will be excluded from the final analysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived Stress Level in Health Students	At baseline (week 0), at the end of the program (week 8), and one month post-intervention (week 12)	This measure assesses participants' perceived stress intensity before and after the intervention using a validated tool such as the Perceived Stress Scale (PSS). It quantifies changes in stress management and evaluates the program's impact on students' psychological well-being.Follow-up assessment will also be conducted one month after the program ends to evaluate the long-term effects.

Secondary Outcome Measures

Name	Time	Method
Anxiety and Depression Levels (HADS) and Sleep Quality (Pittsburgh Sleep Quality Index)	At baseline (week 0), at the end of the program (week 8), and one month post-intervention (week 12)	This measure assesses anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADS) and evaluates sleep quality through the Pittsburgh Sleep Quality Index (PSQI). These validated tools will track changes in participants' anxiety, depression, and sleep disturbances before and after the intervention, providing a comprehensive view of the program's impact on mental health and well-being.

Trial Locations

Locations (1)

Faculties of Sealth Sciences; 🇹🇳 Sfax, Tunisia