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

NCT ID: NCT07123311

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2025-12-15

Brief Summary

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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

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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.

Conditions

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Anxiety Depression (Mild or Not Persistent)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Groupe I

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

Group Type EXPERIMENTAL

Online Stress Management Program

Intervention Type 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 C

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Online Stress Management Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sfax

OTHER

Sponsor Role lead

Responsible Party

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Ines KHARRAT

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rim Masmoudi, Professor in Medicine

Role: STUDY_DIRECTOR

University of Sfax

Jihen Jdidi, Professor in Medicine

Role: STUDY_DIRECTOR

University of Sfax

Locations

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Faculties of Sealth Sciences

Sfax, , Tunisia

Site Status

Countries

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Tunisia

Central Contacts

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Ines Kharrat, Phd Student in Public Health

Role: CONTACT

216 53 116 298

Facility Contacts

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INES KHARRAT, PhD Student

Role: primary

216 53 116 298

Other Identifiers

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FMS-08-05-1982-63-24

Identifier Type: -

Identifier Source: org_study_id

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