Anxiety Depression (Mild or Not Persistent)NCT07123311
Implementation and Evaluation of an Internet-Based Stress Management Program for Health Students in the Sfax Region
A study testing Online Stress Management Program in people with Anxiety Depression (Mild or Not Persistent), run by University of Sfax at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression (Mild or Not Persistent)
- What is being tested?
- Online Stress Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Sep 2025to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Current enrollment in another stress management program;
- History of chronic psychiatric illness;
- Current use of anxiolytic or psychotropic medication.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Online Stress Management Program
- Keywords
- Mental Health, Stress, Psychological / therapy, Students, Internet
- Medical subject headings
- Lymphoma, Follicular, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Stress Management ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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. A long-term follow-up assessment was added six months post-intervention to evaluate the durability of these effects.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start15 Sep 2025
- Primary completion14 Dec 2025
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Depression (Mild or Not Persistent)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines KHARRAT, University of Sfax
- Investigators
- Rim Masmoudi, Professor in Medicine, Study director, University of SfaxJihen Jdidi, Professor in Medicine, Study director, University of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123311
- Sponsor's protocol ID
- FMS-08-05-1982-63-24
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of an Internet-Based Stress Management Program for Health Students in the Sfax Region
- ClinicalTrials.gov ID
- NCT07123311
- Acronym / sponsor ID
- FMS-08-05-1982-63-24
- Keywords
- Mental Health, Stress, Psychological / therapy, Students, Internet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of SfaxUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 14 Dec 2025 (actual)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Groupe I | Experimental | Behavioral: Online Stress Management ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Current enrollment in another stress management program;
- History of chronic psychiatric illness;
- Current use of anxiolytic or psychotropic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Stress Management ProgramThis 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. | Behavioural | Groupe I |
Primary outcome
Perceived Stress Level in Health Students
Time frame: 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)
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.
1 secondary outcome
Anxiety and Depression Levels (HADS) and Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes
Related trials for Anxiety Depression (Mild or Not Persistent)
Active, not recruitingObservational study
Health Surveillance at Constructor University Bremen (CUB)
Social Isolation or Loneliness, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rim Masmoudi, Professor in Medicine study director
University of Sfax
Jihen Jdidi, Professor in Medicine study director
University of Sfax
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Stress Management Program in people with Anxiety Depression (Mild or Not Persistent), run by University of Sfax at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Level in Health Students (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.