Supporting Healthcare and Paramedic Employees (SHAPE)—study protocol for a single-blind, superiority randomised controlled trial evaluating cognitive therapy coaching for PTSD and MDD for health and social care workers in the United Kingdom

Abstract Background This single-blind, superiority randomised controlled trial will evaluate the efficacy of cognitive therapy (CT) coaching for posttraumatic stress disorder (PTSD) and major depressive disorder (MDD) for health and social care workers in the UK compared to a waitlist condition. Methods The trial will include two parallel conditions (intervention and waitlist) using a 1:1 allocation ratio. Assessors of treatment outcome will be blinded to trial condition. Ninety-two participants who meet criteria for PTSD or MDD will be randomly allocated to the intervention or waitlist condition, minimising for key clinical characteristics. Participants allocated to waitlist will be offered the SHAPE intervention afterwards. The intervention will be tailored CT coaching for PTSD and MDD called SHAPE. The primary assessment point is 8 weeks post-random allocation. Further assessment points are 4 weeks post-random allocation and 6 months after receiving the intervention to measure the long-term effects of SHAPE. The primary outcome is SCID-5 diagnosed PTSD and MDD at 8 weeks post-random allocation. The PTSD Checklist for DSM-5 (PCL-5) and the Patient Health Questionnaire (PHQ-9) will be used as secondary measures of PTSD and MDD to assess for symptom severity. Other secondary measures will assess for posttraumatic cognitions, responses to intrusive memories, resilience, wellbeing, and symptom severity for generalised anxiety disorder and insomnia. Health economic analyses will compare the two conditions on quality of life at 8 weeks post-random allocation and compare productivity loss, resource use, and health problems at pre- and post-intervention for everyone who received SHAPE. Patient and provider experience of the SHAPE intervention will be assessed by semi-structured interviews at post-intervention. Discussion This trial will be the first to evaluate the efficacy of CT coaching for PTSD and MDD for UK health and social care workers compared to a waitlist control. Since PTSD symptoms can improve naturally over time, comparison to a waitlist condition allows intervention effects to be distinguished from the effects of time alone. Findings from this trial will inform adaptations that may make the intervention more precise and effective. Trial registration ISRCTN57105098. Registered prospectively on February 21, 2023.