Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic (REST)
Primary Purpose
Stress - Prevention of Sleep Disorders, PTSD and Depression
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Online cognitive behavioral therapy (CBT)
Online bibliotherapy programme
Sponsored by
About this trial
This is an interventional prevention trial for Stress - Prevention of Sleep Disorders, PTSD and Depression
Eligibility 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
Sites / Locations
- Weiner Luisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
7 sessions of the online CBT programme
Bibliotherapy
Arm Description
Outcomes
Primary Outcome Measures
Significant score reduction at the Perceived Stress Scale
Significant score reduction at the Perceived Stress Scale
Significant score reduction at the Perceived Stress Scale
Significant score reduction at the Perceived Stress Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT04362358
First Posted
April 21, 2020
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04362358
Brief Title
Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic
Acronym
REST
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress - Prevention of Sleep Disorders, PTSD and Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
7 sessions of the online CBT programme
Arm Type
Experimental
Arm Title
Bibliotherapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Online cognitive behavioral therapy (CBT)
Intervention Description
7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline
Intervention Type
Behavioral
Intervention Name(s)
Online bibliotherapy programme
Intervention Description
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
Primary Outcome Measure Information:
Title
Significant score reduction at the Perceived Stress Scale
Time Frame
T0 inclusion
Title
Significant score reduction at the Perceived Stress Scale
Time Frame
T1 (3-month follow-up)
Title
Significant score reduction at the Perceived Stress Scale
Time Frame
T1 (up to 8 weeks treatment)
Title
Significant score reduction at the Perceived Stress Scale
Time Frame
T2 (6-month follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luisa Weiner
Organizational Affiliation
Les Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weiner Luisa
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33087178
Citation
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.
Results Reference
derived
Learn more about this trial
Online Cognitive Behavioral Therapy (CBT) for Stress Disorders in Health Workers Involved in the Care of Patients During the Covid-19 Epidemic
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