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

NCT07123311 | Active Not Recruiting

• 1 other identifier: FMS-08-05-1982-63-24
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Depression (Mild or Not Persistent)

Keywords

Mental Health; Stress, Psychological / therapy; Students; Internet

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Level in Health Students

  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 assessments were conducted one month and six months after the program ends to evaluate the durability of treatment effects.

  At baseline (week 0), at the end of the program (week 8), one month post-intervention (week 12), and six months post-intervention (approximately week 34)

Secondary Outcomes (1)

• Anxiety and Depression Levels (HADS) and Sleep Quality (Pittsburgh Sleep Quality Index)

  At baseline (week 0), at the end of the program (week 8), one month post-intervention (week 12), and six months post-intervention (approximately week 34)

Study Arms (2)

Groupe I

EXPERIMENTAL

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

Behavioral: Online Stress Management Program

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.

Interventions

Online Stress Management Program BEHAVIORAL

This is an online pilot stress management program tailored for health students, combining cognitive-behavioral therapy and guided mindfulness meditation. Over eight sessions, participants engage with interactive psychoeducation modules, videos, and practical exercises to understand stress and develop coping strategies. The sessions cover stress awareness, mindfulness meditation (basic and advanced), breathing techniques, time management using the Eisenhower matrix, and cognitive-behavioral methods to foster positive thinking and problem-solving. The final session helps participants create a personalized action plan to integrate learned skills into daily life. Throughout the program, a support group encourages interaction and provides ongoing guidance to enhance well-being and stress management.

Groupe I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current enrollment in another stress management program;
• History of chronic psychiatric illness;
• Current use of anxiolytic or psychotropic medication.

Sponsors & Collaborators

• University of Sfax: lead

Study Sites (1)

Faculties of Sealth Sciences

Sfax, 3041, Tunisia

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Psychological Well-Being

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Personal Satisfaction; Behavior

Study Officials

• Rim Masmoudi, Professor in Medicine

  University of Sfax

  STUDY DIRECTOR

• Jihen Jdidi, Professor in Medicine

  University of Sfax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Complete participant blinding was not feasible given the behavioral nature of the digital intervention, as participants were necessarily aware of their group allocation. Outcome data were collected via automated self-administered online questionnaires, precluding assessor bias. The randomization sequence was concealed from the doctoral candidate coordinating the intervention throughout the study period. The original registration entry indicating quadruple blinding is hereby corrected to reflect actual blinding procedures implemented.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a two-arm, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Participants will be randomly assigned to either an intervention group, which will receive an internet-based stress management program inspired by the validated French program "Je gère mon stress", or to a wait-list control group receiving no intervention during the study period. The study is single-blind (with outcome assessors blinded) and will span 8 weeks, including pre- and post-intervention assessments.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: September 15, 2025
• Primary Completion: December 14, 2025
• Study Completion: July 15, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months after publication of the main results in a peer-reviewed journal.
• Access Criteria: Qualified researchers affiliated with academic or health research institutions will be able to access anonymized individual participant data (IPD), the study protocol, and statistical analysis plan upon request. Access will be granted for scientifically valid research purposes, such as meta-analyses or secondary analyses on mental health interventions. Data will be shared via secured email or encrypted file transfer, following the approval of a data use agreement and submission of a research proposal to the principal investigator.

Locations

TU (1)