- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362358
Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic (REST)
January 16, 2026 updated by: University Hospital, Strasbourg, France
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France, 67000
- Weiner Luisa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Health worker
- Male or Female
- Aged 18-70
- Able to understand the French language
Exclusion Criteria:
- PSS < 16
- Suicidal ideation assessed as < 3 on the item 9 of the PHQ-9
- legally able to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 7 sessions of the online CBT programme
|
7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline
|
|
Active Comparator: Bibliotherapy
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Significant score reduction at the Perceived Stress Scale
Time Frame: T0 inclusion
|
T0 inclusion
|
|
Significant score reduction at the Perceived Stress Scale
Time Frame: T1 (3-month follow-up)
|
T1 (3-month follow-up)
|
|
Significant score reduction at the Perceived Stress Scale
Time Frame: T1 (up to 8 weeks treatment)
|
T1 (up to 8 weeks treatment)
|
|
Significant score reduction at the Perceived Stress Scale
Time Frame: T2 (6-month follow-up)
|
T2 (6-month follow-up)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luisa Weiner, Les Hôpitaux Universitaires de Strasbourg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2020
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
April 21, 2020
First Submitted That Met QC Criteria
April 23, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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