Restore and Rebuild (R&R): a protocol for a phase 2, randomised control trial to compare R&R as a treatment for moral injury-related mental health difficulties in UK military veterans to treatment as usual.

BACKGROUND

Exposure to potentially morally injurious events is increasingly recognised as a concern across a range of occupational groups, including UK military veterans. Moral injury-related mental health difficulties can be challenging for clinicians to treat and there is currently no validated treatment available for UK veterans. We developed Restore and Rebuild (R&R) as a treatment for UK veterans struggling with moral injury-related mental health difficulties. This trial aims to examine whether it is feasible to conduct a pilot randomised controlled trial (RCT) of R&R treatment compared with a treatment-as-usual (TAU) control group.

METHODS

We will use a feasibility single-blind, single-site RCT design. The target population will be UK military veterans with moral injury-related mental health difficulties. We will recruit N=46 veteran patients who will be randomly allocated to R&R (n=23) or TAU (n=23). Patients randomised to R&R will receive the 20-session one-to-one treatment, delivered online. Veterans allocated to TAU, as there are currently no manualised treatments for moral injury-related mental health problems available, will receive the one-to-one treatment (online) typically provided to veterans who enter the mental health service for moral injury-related mental health difficulties. We will collect outcome measures of moral injury, post-traumatic stress disorder (PTSD), alcohol misuse, common mental disorders and trauma memory at pretreatment baseline (before randomisation), end of treatment, 12 weeks and 24 weeks post-treatment. The primary outcome will be the proportion of patients who screen positive for PTSD and moral injury-related distress post-treatment.

ETHICS AND DISSEMINATION

This trial will establish whether R&R is feasible, well-tolerated and beneficial treatment for veterans with moral injury-related mental health difficulties. If so, the results of the trial will be widely disseminated and R&R may improve access to effective care for those who struggle following moral injury and reduce the associated negative consequences for veterans, their families and wider society.

TRIAL REGISTRATION NUMBER

ISRCTN99573523.

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: Authors had financial support from a grant from the Forces in Mind Trust for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work. DM is a trustee for the funder of this project, the Forces in Mind Trust. DL is a reservist in the UK Armed Forces. This work has been undertaken as part of his civilian employment. For the purposes of open access, the author has applied a Creative Commons Attribution (CC BY) license to any Accepted Author Manuscript version arising from this submission.