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
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
Overall status: COMPLETED
Phase: NA
Conditions: Stress - Prevention of Sleep Disorders, PTSD and Depression
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Significant score reduction at the Perceived Stress Scale
timeFrame: T0 inclusion
measure: Significant score reduction at the Perceived Stress Scale
timeFrame: T1 (3-month follow-up)
measure: Significant score reduction at the Perceived Stress Scale
timeFrame: T1 (up to 8 weeks treatment)
measure: Significant score reduction at the Perceived Stress Scale
timeFrame: T2 (6-month follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Weiner Luisa
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Luisa Weiner
role: PRINCIPAL_INVESTIGATOR
References:
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.