NCT04362358

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

April 21, 2020

Last Update Submit

January 16, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Significant score reduction at the Perceived Stress Scale

    T0 inclusion

  • Significant score reduction at the Perceived Stress Scale

    T1 (3-month follow-up)

  • Significant score reduction at the Perceived Stress Scale

    T1 (up to 8 weeks treatment)

  • Significant score reduction at the Perceived Stress Scale

    T2 (6-month follow-up)

Study Arms (2)

7 sessions of the online CBT programme

EXPERIMENTAL
Behavioral: Online cognitive behavioral therapy (CBT)

Bibliotherapy

ACTIVE COMPARATOR
Behavioral: Online bibliotherapy programme

Interventions

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

Bibliotherapy

7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline

7 sessions of the online CBT programme

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health worker
  • Male or Female
  • Aged 18-70
  • Able to understand the French language

You may not qualify if:

  • PSS \< 16
  • Suicidal ideation assessed as \< 3 on the item 9 of the PHQ-9
  • legally able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weiner Luisa

Strasbourg, 67000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Luisa Weiner

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

July 20, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations