Anxiety Depression (Mild or Not Persistent)
Conditions
Keywords
Mental Health, Stress, Psychological / therapy, Students, Internet
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.
Interventions
BEHAVIORALOnline 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.
Sponsors
University of Sfax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Level in Health Students | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
Tunisia
Contacts
STUDY_DIRECTORRim Masmoudi, Professor in Medicine
University of Sfax
STUDY_DIRECTORJihen Jdidi, Professor in Medicine
University of Sfax
Outcome results
None listed