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Premature call for implementation of Tetris in clinical practice: a commentary on Deforges et al. (2023)

Molecular Psychiatry (2024)Cite this article

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Deforges and colleagues [1] recently reported the results of the Swiss TrAumatic biRth Trial (START); a superiority trial comparing a single session visuospatial task (playing Tetris) to an attention-control in preventing childbirth-related posttraumatic stress disorder (CB-PTSD). The trial focuses on an important postpartum mental health issue, has several apparent strengths such as adequate randomization and efforts to maintain masking/blinding and includes a potentially scalable and easy to implement intervention. However, we are concerned that the effects of the intervention were exaggerated, owing to issues of selective reporting, lack of multiplicity corrections in the statistical analyses and to interpretive bias or “spin”, where the results are presented in a manner that highlights the benefits of the experimental treatment, despite a statistically non-significant difference for the primary outcomes.

The trial registration at ClinicalTrials.gov (NCT03576586) and the protocol [2] mention several co-primary outcomes; the presence and severity of post-traumatic stress disorder (PTSD) symptoms as measured by two separate scales (i.e. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD Checklist for DSM-5 (PCL-5)) and their respective subscales, at the timepoint of 6 weeks postpartum. Though the trial registration and protocol explicitly specify that mean total and subscale scores of both the CAPS-5 and PCL-5 are at least part of the primary outcome, these data are not reported in the article. No justification for this apparent discrepancy is provided. Instead, both scales are scored exclusively by computing the total number of symptoms, with a symptom considered present when scored over 2. Severity, as indexed by the total score, is not reported, though it is ostensibly part of the primary outcome. We have requested this missing information from the trial authors, but have not received it up to this point. The authors list the prospective trial registration as a strong point of their study (p. 7). However, the main purpose of prospective registration is transparency, which entails fully describing and justifying protocol deviations, particularly major ones.

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References

  1. Deforges C, Sandoz V, Noël Y, Avignon V, Desseauve D, Bourdin J, et al. Single-session visuospatial task procedure to prevent childbirth-related posttraumatic stress disorder: a multicentre double-blind randomised controlled trial. Mol Psychiatry. 2023;28:3842–50.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Sandoz V, Deforges C, Stuijfzand S, Epiney M, Vial Y, Sekarski N, et al. Improving mental health and physiological stress responses in mothers following traumatic childbirth and in their infants: study protocol for the Swiss TrAumatic biRth Trial (START). BMJ Open. 2019;9:e032469.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Wood J, Freemantle N, King M, Nazareth I. Trap of trends to statistical significance: Likelihood of near significant P value becoming more significant with extra data. BMJ. 2014;348:g2215.

    Article  PubMed  Google Scholar 

  4. Iyadurai L, Blackwell SE, Meiser-Stedman R, Watson PC, Bonsall MB, Geddes JR, et al. Preventing intrusive memories after trauma via a brief intervention involving Tetris computer game play in the emergency department: a proof-of-concept randomized controlled trial. Mol Psychiatry. 2018;23:674–82.

    Article  CAS  PubMed  Google Scholar 

  5. Kanstrup M, Singh L, Göransson KE, Widoff J, Taylor RS, Gamble B, et al. Reducing intrusive memories after trauma via a brief cognitive task intervention in the hospital emergency department: an exploratory pilot randomised controlled trial. Transl Psychiatry. 2021;11:30.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Abraha I, Cherubini A, Cozzolino F, Florio RD, Luchetta ML, Rimland JM, et al. Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. BMJ Br Med J. 2015;350:h2445.

    Article  Google Scholar 

  7. Vickerstaff V, Ambler G, King M, Nazareth I, Omar RZ. Are multiple primary outcomes analysed appropriately in randomised controlled trials? A review. Contemp Clin Trials. 2015;45:8–12.

    Article  PubMed  Google Scholar 

  8. Resick PA, Straud CL, Wachen JS, LoSavio ST, Peterson AL, McGeary DD, et al. A comparison of the CAPS-5 and PCL-5 to assess PTSD in military and veteran treatment-seeking samples. Eur J Psychotraumatol. 2023;14:2222608.

    Article  PubMed  PubMed Central  Google Scholar 

  9. Vickerstaff V, Omar RZ, Ambler G. Methods to adjust for multiple comparisons in the analysis and sample size calculation of randomised controlled trials with multiple primary outcomes. BMC Med Res Methodol. 2019;19:129.

    Article  PubMed  PubMed Central  Google Scholar 

  10. Hewitt CE, Mitchell N, Torgerson DJ. Listen to the data when results are not significant. BMJ. 2008;336:23–5.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Stoll M, Mancini A, Hubenschmid L, Dreimüller N, König J, Cuijpers P, et al. Discrepancies from registered protocols and spin occurred frequently in randomized psychotherapy trials—A meta-epidemiologic study. J Clin Epidemiol. 2020;128:49–56.

    Article  PubMed  Google Scholar 

  12. Boutron I, Dutton S, Ravaud P, Altman DG. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010;303:2058–64.

    Article  CAS  PubMed  Google Scholar 

  13. Boutron I, Altman DG, Hopewell S, Vera-Badillo F, Tannock I, Ravaud P. Impact of Spin in the Abstracts of Articles Reporting Results of Randomized Controlled Trials in the Field of Cancer: The SPIIN Randomized Controlled Trial. J Clin Oncol. 2014;32:4120–6.

    Article  PubMed  Google Scholar 

  14. Khanpara H, Prakash V. Effect of spin in the abstract of a randomised controlled trial on physiotherapists’ perception of treatment benefit: a randomised controlled trial. BMJ Evid Based Med. 2022;27:97–103.

    Article  PubMed  Google Scholar 

  15. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Butcher NJ, Monsour A, Mew EJ, Chan A-W, Moher D, Mayo-Wilson E, et al. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022;328:2252–64.

    Article  PubMed  Google Scholar 

  17. Higgins J, Savović J, Page M, Elbers R, Sterne J. Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins J, Thomas J, Chandler J, Cumpston M, Li T, Page M, et al., editors. Cochrane Handbook for Systematic Reviews of Interventions: Cochrane; 2023. Availabe from https://training.cochrane.org/handbook/current/chapter-08.

  18. Mandrola J, Cifu A, Prasad V, Foy A. The Case for Being a Medical Conservative. Am J Med. 2019;132:900–1.

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Psychological outpatient clinic for adults, Department of Psychology, Norwegian University of Science and Technology (NTNU), N-7491, Trondheim, Norway

    Joar Øveraas Halvorsen

  2. St. Olav’s University Hospital, Trondheim, Norway

    Joar Øveraas Halvorsen

  3. Department of Psychology, University of Groningen, Groningen, The Netherlands

    Ineke Wessel

  4. Department of General Psychology, University of Padova, Padova, Italy

    Ioana A. Cristea

Authors
  1. Joar Øveraas Halvorsen
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  2. Ineke Wessel
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JØH and IAC conceptualized the main arguments, and JØH wrote the first draft. JØH, IW and IAC contributed substantially to the revisions of the manuscript.

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Correspondence to Joar Øveraas Halvorsen.

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Halvorsen, J.Ø., Wessel, I. & Cristea, I.A. Premature call for implementation of Tetris in clinical practice: a commentary on Deforges et al. (2023). Mol Psychiatry (2024). https://doi.org/10.1038/s41380-024-02642-1

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