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FxStat is a company registered in England and Wales under registered number: Sign In. Remember me. Forgot your password? You are currently not signed in. Please sign in or register. Date range. A scientific committee composed of the main investigator LW , two associated investigators NN, ACM , a methodologist FS , and a promoter representative wrote the protocol, selected the investigators, and decided whether to modify, continue, or stop the project.
A data management team composed of two data managers configured the online survey software CleanWeb and made sure data storage was secure. The promoter will update the information about the trial on Clinicaltrials. Each session is preceded and followed by VAS to aid participants to identify their subjective manifestations of stress and assess the utility of the session.
In addition, by the end of each session, participants have the possibility to call a psychologist from the hotline and are invited to practice the strategies learned between sessions through the use of the homework material associated with each video, including mindfulness and relaxation exercises see Table 2 for the content of the sessions.
Bibliotherapy consists here of brochures with self-help written relaxation material, which provides low-intensity intervention for stress that should be less efficacious than online CBT [ 29 ]. Participants will be able to download these brochures, in a pdf format, via the MaSanteAussi.
The brochures contain psychoeducation as well as written and illustrated instructions to guide relaxation and mindfulness practices. In addition to the written material, people will also have the possibility to call the psychological hotline throughout the 8-week duration of the study.
A hotline specifically dedicated to the participants will be set up, run by a team of CBT-trained psychologists. If the participant presents with more severe psychological symptoms i. In addition, weekly supervision will be provided by the senior psychologists who created the program. The site will be hosted by the University Hospital of Strasbourg, accredited to host health data. All data collected will be anonymized, coded, and stored on this secure server.
A table of correspondence between the names and anonymous identifiers will be kept by the investigators in paper format, in secure facilities at their center. Any data required to support the protocol can be supplied on request.
The randomization will be stratified by the investigation center with a ratio for allocation to the 2 groups. Blocks of varying sizes will be randomly selected. The allocation sequence was configured by our data manager who is blinded to the allocation group.
Participants will be informed of the group which they are allocated to. A descriptive analysis will be performed on the entire population and in each group experimental and control. Categorical variables will be described, giving the numbers and frequency of each modality. Quantitative variables will be described using the usual positional and dispersion parameters. The data analyst will be blinded as he will not participate to data collection. The statistical test of interest will focus on the interaction term between group and time, which will assess whether the decrease in the PSS score is greater in the experimental group than in the control group.
In a second step, if this test is significant, we will estimate the decrease difference between the groups. In the case of restricted scores with values close to the extremes, we may use beta regression models after transformation of the variable of interest on a scale of ]0;1[. Regarding the predictive factors of the efficacy of online CBT, we will also use the aforementioned models, incorporating an interaction between group, time, and each potential predictive factor to test whether the improvement of scores in the CBT group relies on another factor.
Also, we will carry out the identification of potential mediating factors explaining the effect of CBT on professional stress using Bayesian networks that allow learning the structure of a system from the data while integrating hypotheses about the structure. Mediation formulae will be used to assess total, direct and indirect effects. Finally, we will perform a descriptive analysis of the indicators of acceptability and satisfaction.
In order to minimize attrition bias, an intention to treat analysis and specific techniques for handling missing data will be performed. Missing data will be described variable by variable and as a whole in order to search for monotonous patterns.
In order to determine the process of generating the missing data MCAR: missing completely at random, MAR: missing at random or MNAR: missing not at random , dummy variables for whether a variable is missing will be created and cross-tabulated with others observed variables.
Multivariate logistic regression can be used to determine a set of variables associated with the probability of observation. To the best of our knowledge, this will be the first randomized controlled trial comparing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers and of an active control group i. Indeed, if our 7-session online CBT program produces a significant decrease on immediate perceived stress levels and improves the prevention of severe psychiatric disorders, such as PTSD and depression, it could become an empirically assessed viable option specifically suited to the needs of healthcare workers facing the COVID pandemic and might be easily adapted to other sanitary crises.
Indeed, in terms of format and content, this brief online CBT format has many advantages in the current context: first, similar programs have proved to improve resilience in highly stressful situations and prevent the emergence of psychological disorders [ 25 ]; second, it circumvents some of the pitfalls associated with face-to-face interventions e.
In addition, we have chosen a step-by-step guided format rather than a free access to the program sessions in a random order. This format mimics the outline of standard face-to-face CBT possibly enhancing the effectiveness of the program.
Our study protocol has some limitations. First of all, this study design does not include a control arm that could account for the effects of the passage of time. Although this could provide a more rigorous test of our study hypotheses, a third control arm e. Second, though concomitant psychotropic medications as well as the use of adjunctive therapeutic means e. While this might be a potential confound in the current study design, the restriction of therapeutic options would also pose an ethical concern, reduce referrals to the study and also be a threat to external validity.
Therefore, by monitoring therapeutic i. To summarize, if our study hypotheses are confirmed, our program has the potential to become the first evidence-based option developed for the treatment of stress-related conditions i. Study enrollment will begin in June , by the end of the epidemic peak in the East region of France. The dissemination of first results at international meetings is expected by October Publication of the findings is planned for March The consent form and information material are available from the corresponding author on request.
Psychiatry Res. Duan L, Zhu G. Lancet Psychiatry. Multidisciplinary research priorities for the COVID pandemic: a call for action for mental health science. Huang Y, Zhao N. Generalized anxiety disorder, depressive symptoms and sleep quality during COVID outbreak in China: a web-based cross-sectional survey.
Rajkumar RP. COVID and mental health: a review of the existing literature. Asian J Psychiatry. Article Google Scholar. A study of basic needs and psychological wellbeing of medical workers in the fever clinic of a tertiary general hospital in Beijing during the COVID outbreak. Psychother Psychosom. Google Scholar. J Clin Psychiatry. PubMed Article Google Scholar. Caring for the psychological well-being of healthcare professionals in the Covid pandemic crisis.
Ir Med J. Hu X, Huang W. Protecting the psychological well-being of healthcare providers affected by the COVID outbreak: implications for the psychological rescue work of international community. Nurs Health Sci.
World J Urol. Maben J, Bridges J. J Clin Nurs. A multinational, multicentre study on the psychological outcomes and associated physical symptoms amongst healthcare workers during COVID outbreak. Brain Behav Immun. Survey of insomnia and related social psychological factors among medical staff involved in the novel coronavirus disease outbreak.
Front Psychiatry. Ullah R, Amin S. Maunder RG. Was SARS a mental health catastrophe? Gen Hosp Psychiatry. Quality of life and psychological status in survivors of severe acute respiratory syndrome at 3 months postdischarge. J Psychosom Res. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis.
Prevalence of psychiatric disorders among Toronto hospital workers one to two years after the SARS outbreak. Psychiatr Serv Wash DC. Are burnout prevention programs for hospital physicians needed? Interventions for the prevention of posttraumatic stress disorder PTSD in adults after exposure to psychological trauma. Book Google Scholar. Depression prevention via digital cognitive behavioral therapy for insomnia: a randomized controlled trial.
A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. Behav Res Ther. Efficacy of an Internet-based intervention for job stress and burnout among medical professionals: study protocol for a randomized controlled trial. Road to resilience: a systematic review and meta-analysis of resilience training programmes and interventions.
BMJ Open. J Med Internet Res. Online cognitive-behavioural treatment of bulimic symptoms: a randomized controlled trial. Clin Psychol Psychother. A global measure of perceived stress. J Health Soc Behav. Kroenke K, Spitzer RL. The PHQ a new depression diagnostic and severity measure.
Psychiatr Ann. Psychometric properties of the French versions of the Perceived Stress Scale. Factorial validation of the french scale for perceived stress in the workplace. Ann Fam Med. Depress Anxiety. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med. The relation of post-work ruminative thinking with eating behaviour.
J Behav Ther Exp Psychiatry. Attkisson CC, Zwick R. The Client Satisfaction Questionnaire: psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Prog Plann. Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis.
Clin Psychol Rev. The effects of social support on sleep quality of medical staff treating patients with coronavirus disease COVID in January and February in China. Folkman S, Lazarus RS. Stress, Appraisal, and Coping. New York: Springer Publishing Company; Acceptance and commitment therapy: model, processes and outcomes.
Gilbert P. Compassion-focused therapy: preface and introduction for special section. Br J Clin Psychol.
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