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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief 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 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

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Significant score reduction at the Perceived Stress Scale [ Time Frame: T0 inclusion ]
  2. Significant score reduction at the Perceived Stress Scale [ Time Frame: T1 (3-month follow-up) ]
  3. Significant score reduction at the Perceived Stress Scale [ Time Frame: T1 (up to 8 weeks treatment) ]
  4. Significant score reduction at the Perceived Stress Scale [ Time Frame: T2 (6-month follow-up) ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Luisa Weiner, MD 03 88 11 65 11 luisa.weiner@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders