Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic (REST)
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ClinicalTrials.gov Identifier: NCT04362358 |
Recruitment Status :
Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stress - Prevention of Sleep Disorders, PTSD and Depression | Behavioral: Online cognitive behavioral therapy (CBT) Behavioral: Online bibliotherapy programme | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Estimated Study Start Date : | May 1, 2020 |
Estimated Primary Completion Date : | October 1, 2021 |
Estimated Study Completion Date : | October 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 7 sessions of the online CBT programme |
Behavioral: Online cognitive behavioral therapy (CBT)
7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline |
Active Comparator: Bibliotherapy |
Behavioral: Online bibliotherapy programme
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 |
- 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) ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362358
Contact: Luisa Weiner, MD | 03 88 11 65 11 | luisa.weiner@chru-strasbourg.fr |
Responsible Party: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT04362358 |
Other Study ID Numbers: |
7799 |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | April 24, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sleep Wake Disorders Nervous System Diseases Neurologic Manifestations Mental Disorders |