Document is current

Article History

Received: 14 November 2019

Accepted: 17 February 2020

First Online: 23 April 2020

Ethics approval and consent to participate

: The study was approved on 4 January 2018 by the West Midlands – Black Country Research Ethics Committee, ref: 17/WM/0441 (IRAS project ID: 224759, Protocol version 1, 9 November 2017) and local research governance approval has been obtained for all collaborating NHS Trusts. All participants will give written consent prior to their taking part in two steps, consent to initial assessment and consent to participate in the trial, which will be obtained by a trial administrator or the clinician conducting the clinical assessment. The original power analysis had to be revised in November 2018 due to loss of therapists, and therapist absence due to illness and maternity leave, which increased the cluster size and coefficient of variation compared to the original power calculation (Protocol version 2, 25 November 2018). The adjustment is in line with statistical guidance for clinical trials []. Minor edits of the wording of the statistical analysis section were completed in line with the statistical analysis plan (Protocol version 3, 26 September 2019). The trial will be conducted in compliance with the principles of the Declaration of Helsinki (1996) and the principles of Good Clinical Practice.

: Not applicable

: iCT-PTSD was developed by Anke Ehlers and David M Clark’s team and iStress was developed by Gerhard Andersson’s team.