Stress - Prevention of Sleep Disorders, PTSD and DepressionRESTNCT04362358
Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic
A study testing Online cognitive behavioral therapy (CBT) and Online bibliotherapy programme in people with Stress - Prevention of Sleep Disorders, PTSD and Depression, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their well-being as well as their ability to work… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress - Prevention of Sleep Disorders, PTSD and Depression
- What is being tested?
- Online cognitive behavioral therapy (CBT) and Online bibliotherapy programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health worker
- Male or Female
- Aged 18-70
- Able to understand the French language
Who cannot join
- PSS < 16
- Suicidal ideation assessed as < 3 on the item 9 of the PHQ-9
- legally able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Online Cognitive Behavioral Therapy (CBT) Programme Aiming at Reducing the Stress of Health Workers Involved in the Care of Patients During the Covid-19 Epidemic: a Randomized-controlled Trial
Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their well-being as well as their ability to work effectively . These rates were observed during the epidemic peak, but they can also have a long-term mental health effect, both individually, but also in a systemic manner , similar to what has been reported relative to the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment for stress-reduction, as well as for the prevention of multiple mental health problems in at-risk individuals . Moreover, CBT has been found to be effective in brief online formats , which could make it feasible during the current Covid-19 epidemic. To our knowledge, there are no online CBT programmes targeting stress problems in health workers involved in the care of patients during the current epidemic context. The aim of our study is to evaluate the efficacy of the online CBT programme we have developped to specifically address immediate perceived stress in health workers, as well as the prevention of mental health problems at 3- and 6-months follow-up
- Being tested
- Online cognitive behavioral therapy (CBT), Online bibliotherapy programme
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online cognitive behavioral therapy (CBT)Behavioural
7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline
Online bibliotherapy programmeBehavioural
online bibliotherapy programme on the Ma Santé website Also with explanatory sheets and tools to improve stress management and the possibility of contacting the Psychological Hotline
| Study group | Role | What they receive |
|---|---|---|
| 7 sessions of the online CBT programme | Experimental | Not described Receives: Behavioral: Online cognitive behavioral therapy (CBT) |
| Bibliotherapy | Active comparator | Not described Receives: Behavioral: Online bibliotherapy programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant score reduction at the Perceived Stress Scale
Measured: T0 inclusion
Significant score reduction at the Perceived Stress Scale
Measured: T1 (3-month follow-up)
Significant score reduction at the Perceived Stress Scale
Measured: T1 (up to 8 weeks treatment)
Significant score reduction at the Perceived Stress Scale
Measured: T2 (6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Jul 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress - Prevention of Sleep Disorders, PTSD and DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luisa Weiner, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362358
- Sponsor's protocol ID
- 7799
- Acronym
- REST
- Status last verified
- Jan 2026
- First submitted
- 21 Apr 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiner L, Berna F, Nourry N, Severac F, Vidailhet P, Mengin AC. Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial. Trials. 2020 Oct 21;21(1):870. doi: 10.1186/s13063-020-04772-7.
PubMed 33087178
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Online Cognitive Behavioral Therapy (CBT) Programme Aiming at Reducing the Stress of Health Workers Involved in the Care of Patients During the Covid-19 Epidemic: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04362358
- Acronym / sponsor ID
- REST / 7799
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Apr 2020 (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.
Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their well-being as well as their ability to work effectively . These rates were observed during the epidemic peak, but they can also have a long-term mental health effect, both individually, but also in a systemic manner , similar to what has been reported relative to the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment for stress-reduction, as well as for the prevention of multiple mental health problems in at-risk individuals . Moreover, CBT has been found to be effective in brief online formats , which could make it feasible during the current Covid-19 epidemic. To our knowledge, there are no online CBT programmes targeting stress problems in health workers involved in the care of patients during the current epidemic context. The aim of our study is to evaluate the efficacy of the online CBT programme we have developped to specifically address immediate perceived stress in health workers, as well as the prevention of mental health problems at 3- and 6-months follow-up
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 sessions of the online CBT programme | Experimental | Behavioral: Online cognitive behavioral therapy (CBT) |
| Bibliotherapy | Active comparator | Behavioral: Online bibliotherapy programme |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Health worker
- Male or Female
- Aged 18-70
- Able to understand the French language
Key exclusion criteria (3 listed)
- PSS < 16
- Suicidal ideation assessed as < 3 on the item 9 of the PHQ-9
- legally able to provide informed consent
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 cognitive behavioral therapy (CBT)7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline | Behavioural | 7 sessions of the online CBT programme |
| Online bibliotherapy programmeonline bibliotherapy programme on the Ma Santé website Also with explanatory sheets and tools to improve stress management and the possibility of contacting the Psychological Hotline | Behavioural | Bibliotherapy |
Primary outcome
Significant score reduction at the Perceived Stress Scale
Time frame: T0 inclusion
Significant score reduction at the Perceived Stress Scale
Time frame: T1 (3-month follow-up)
Significant score reduction at the Perceived Stress Scale
Time frame: T1 (up to 8 weeks treatment)
Significant score reduction at the Perceived Stress Scale
Time frame: T2 (6-month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 33087178Weiner L, Berna F, Nourry N, Severac F, Vidailhet P, Mengin AC. Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial. Trials. 2020 Oct 21;21(1):870. doi: 10.1186/s13063-020-04772-7.
- Individual participant dataSharing planned: No
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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.
Luisa Weiner principal investigator
Les Hôpitaux Universitaires de Strasbourg
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 cognitive behavioral therapy (CBT) and Online bibliotherapy programme in people with Stress - Prevention of Sleep Disorders, PTSD and Depression, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 20 Jan 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Significant score reduction at the Perceived Stress Scale (time frame: T0 inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362358, which also lists 1 linked publication.
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 20 Jan 2026.