Ethical approval

This study was reviewed and approved by King’s College London Research Ethics Committee (HR/DP-22/23-36849).

Study setting

The study setting is Combat Stress, a leading UK charity delivering trauma-focused care to military veterans across the UK.

Patient and public involvement

R&R was codesigned using extensive input from UK veterans as well as leading international experts.36 In this study, an independent steering committee consisting of UK military veterans, military chaplains, clinicians and leading international experts in the field of moral injury will provide patient and public input on study materials/procedures, monitor study progress, advise the investigators on scientific/management issues and ensure no major deviations from the study protocol occur.

Eligibility criteria

Veteran patients: Eligible participants for both arms of the trial will be UK military veterans who have completed a clinical assessment of Combat Stress. Veterans must have been clinically assessed to have a military-attributable moral-injury-related mental health difficulty. No limitations on eligibility according to demographic characteristics (eg, gender, age and rank) will be imposed. Moreover, we will not restrict participation by deployment location or military role. Exclusion criteria are listed in table 1.

Exclusion and inclusion criteria will be screened through a review of patient notes following an initial clinical assessment at Combat Stress, as well as during a screening call prior to informed consent. Any patients who do not meet the study inclusion criteria will be referred to services that better meet their needs by the Combat Stress clinician.

Inclusion criteria for qualitative interview: To be eligible for a qualitative interview, the veteran patients must have completed (or dropped out of) the R&R treatment and provided written informed consent, including consent for audio recording the interview.

Sample size

A power calculation is typically used to determine the sample size needed to detect an effect of a given size with a certain degree of confidence. However, as this is a pilot, exploratory study a calculation has not been performed. Following a pragmatic approach and consistent with previous pilot studies of PTSD and complex PTSD,37–39 we aim to recruit n=23 individuals per arm (total sample=46). This approach will enable us to answer our research questions and calculate a sample size for an adequately powered, full-scale future trial.

Recruitment

When entering Combat Stress clinical service, all presenting veterans receive a comprehensive full clinical assessment by a member of the interdisciplinary team (IDT). PMIE exposure and associated distress will initially be determined via clinician rating as all veterans are asked to provide an overview of their exposure to trauma and related symptoms as part of this assessment. All cases are discussed at a weekly case IDT management meeting. The details of veterans who express symptoms of moral injury-related mental health difficulties, and are deemed ready for therapy by the IDT, will be forwarded to the research team for review. Following a review of the completed assessment, the research team will approach the veteran to book a screening call for the trial. During the screening call, the veteran will then be assessed by the research therapist to confirm that moral injury appears to be their main presenting difficulty. Eligible veterans who are interested in taking part in the trial will then be sent a study information pack, including an information sheet and consent form. Once written consent is received, the research team will invite the veteran to complete the pre-treatment baseline measures sent via a secure email link. Following the completion of the well-being measures, veterans will be randomised into R&R or TAU. The research assistant will inform the Combat Stress clinical care team of the outcome so veterans in TAU, or those who opted not to participate in the trial, can be offered the standard treatment.

Assignment of interventions: allocation and blinding

Veteran patients will be randomly allocated to treatment group to minimise bias. Asymptotic maximal procedure will be used to randomly assign patients to treatment groups.40 Randomised lists will be generated using an online, closed-source, tool (https://ctrandomization.cancer.gov/tool/). Randomisation will be overseen by DL.

Interventions

R&R: R&R is a manualised, 20-session talking therapy.36 Treatment is delivered one-to-one between therapist and patient, remotely via Microsoft Teams. Sessions are 60 min in length and occur weekly, however, a 4-week break in sessions takes place between sessions 19 and 20 (the final session). Following a review of existing treatments and codevelopment with experts and veterans with moral injury,41 R&R was designed to include moral injury psychoeducation; discussion of the PMIE(s); exploration of postevent changes in beliefs and thought processes; support to adaptively rewrite or update these; and an examination of core values and goals for the future. R&R includes in-session discussions with a therapist, as well as written exercises, thought records and worksheets, completed both inside and outside of sessions by veteran patients. An outline of treatment sessions can be found in table 2.

TAU: Since there is a lack of validated manualised treatments for moral injury available at present, TAU will be the one-to-one treatment that would typically be provided to veterans who entered Combat Stress for treatment for moral injury-related mental health difficulties. TAU will consist of one-to-one trauma-focused therapy with a therapist from the broader Combat Stress clinical team, delivered online. TAU is expected to include elements of psychoeducation, symptom management and therapy intervention; typically following a CBT or cognitive processing therapy model.42 Details of the TAU intervention provided to all TAU-arm participants will be recorded (eg, treatment given and number of sessions).

Outcome measures

Well-being outcome measures: To analyse the impact of R&R versus TAU on reducing the severity of veteran patient moral injury-related mental health symptoms, several self-report measures will be collected from all veteran patients at various time points pretreatment and post-treatment (see table 1).

The primary outcome measures will be the Moral Injury Outcome Scale,18 which measures symptoms of moral injury, and the International Trauma Questionnaire43 which measures symptoms of PTSD and complex PTSD.

Secondary outcome measures will also include the Moral Injury Scale (Williamson et al, under review), which measures moral injury-related distress. Symptoms of PTSD will be measured using PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).44 The Patient Health Questionnaire-945 will be used to measure symptoms of depression. The Dimensions of Anger Reactions scale-546 will be used to measure anger and the Alcohol Use Disorders Identification Test47 will be used to measure alcohol usage. Social support will be measured using the Oslo Social Support Scale-3.48 The Short Warwick-Edinburgh Mental Well-being Scale49 50 will be used to measure general mental well-being. The Short Form Health Survey-12 will be used to measure physical health outcomes.51 Finally, a short measure of moral injury memory perspective will be used, adapted from Wells and Papageorgiou.52 This measure will be used to record the veteran patients’ trauma memory perspective and whether this viewpoint changes during treatment (online supplemental material 2).

Additional information and measures: Demographic information (eg, age, gender, military branch and years of military service) will be collected from veteran patients at baseline. Health economics information will also be collected (at baseline, end of treatment and 24 weeks post-treatment, see table 3) to explore whether, over the last 6 months, the veteran patient’s mental health has led to their: having had days off work; visits to Accident and Emergency departments and/or hospital; visits to their general practitioner; contact with the police or use of mental health helplines (eg, Samaritans). Treatment-related data will be collected relating to the number of R&R and TAU sessions attended, the number and nature of any serious adverse events, the number of patients who dropped out after the first treatment session, and any patients who are lost to follow-up. Serious adverse events will be defined according to the National Research Ethics Service Guidelines.53

Qualitative interviews: To gain an in-depth understanding of whether R&R is acceptable and well tolerated, up to 23 veteran patients will be invited to interview at the end of their treatment by a study researcher (VW). Any veterans who drop-out of R&R treatment will also be approached and invited to interview to explore their experiences of treatment. Prior to interviews, veterans will be informed that their interviews will be anonymised with identifying information removed on transcription and their participation in the interview will not impact the care they receive from Combat Stress or other services.

The interview schedule (online supplemental material 3) will be informed by the research aims, the wider moral injury literature and previous qualitative studies of experiences of psychological treatment for moral injury.8 9 11 17 54 Interviews will focus on veterans’ experiences of accessing psychological treatment, their perceptions of being offered a novel treatment for moral injury and taking part in the RCT, their experience of receiving R&R, aspects of the R&R treatment that did/did not work well, the impact of R&R on their daily functioning and well-being, barriers and facilitators to treatment and perceptions of any outstanding support needs. Veteran patients who received TAU will not be interviewed as considerable evidence already exists regarding perceptions of existing psychological treatments for moral injury-related mental health difficulties.17 23 55 Interviews will be conducted by telephone or MS Teams and audio recorded with patient consent. Interviews will be transcribed verbatim, with audio recordings destroyed following transcription. It is beyond the scope of this study to share transcripts with participants for triangulation.

Planned data analysis

Quantitative: STATA V.17 will be used to analyse the data. Descriptive statistics will be calculated for baseline, follow-up and change scores for outcome measures with paired t-tests used to test for significant changes in scores from baseline and between treatment groups (R&R vs TAU). Descriptive statistics will also be used to examine the treatment delivery information (eg, number of sessions attended and drop-out) to explore acceptability and feasibility. Should there be missing data, multiple imputation methods will be used.

Qualitative: Interviews with R&R veteran patients (N=23) will be analysed using thematic analysis.56 Interview data will be preliminary coded using an inductive ‘bottom-up’ approach. Researchers will familiarise themselves with the data by reading and re-reading the transcripts; they will generate early codes; search for and generate preliminary themes; and then finalise superordinate themes. Credibility will be checked via analytical triangulation using reflective discussions with coauthors. A reflexive journal will be also kept57 in order to note the influence of the researchers’ views, expectations or assumptions, and experiences to prevent premature or biased interpretation of the data.

Data management

We will use Qualtrics to securely collect self-report questionnaire assessments at baseline, session 19, post-treatment, and 12 weeks and 24 weeks post-treatment. Following questionnaire completion, data will be stored on secure KCL servers. Each veteran patient will be assigned a unique ID, and all study data will be labelled with ID (not name). A document linking patient ID and personal details and contact information will be stored separately from other data, with access restricted to the research team directly involved in collecting data and delivering treatment. At the end of the trial, the linking document including personal/contact information will be deleted. Pseudonymised study databases will be examined, cleaned, locked and signed off by senior authors prior to securely sharing with the study statistician (DL). Once the main trial analyses are completed and published, we plan to make a sufficiently anonymised version of the main study databases available on a public repository for use by other researchers.

Adverse events reporting and harms

Protocols for managing any risk or safeguarding concerns will be followed, and any potential adverse events will be recorded and monitored in line with the study adverse events protocol and Combat Stress standard operating procedures. Potential adverse events will be recorded, logged and monitored by the study clinicians and senior authors, and serious adverse events will be reported to the study’s independent steering committee and the director of Combat Stress.

Participant withdrawal or discontinuation

Veteran patients in both arms will be free to withdraw from the trial at any point, without giving a reason and without their legal rights or care being affected. The study team may also withdraw veteran patients if they consider their continuation to be harmful. The study team will review all occurrences of adverse events, whether events are considered to be attributable to the trial, and decide whether the veteran patient should be withdrawn from the study. Non-identifiable data from veteran patients who have been withdrawn from the study will be used to assess trial feasibility. Patient engagement may be ceased based on adverse events. In the case of an adverse event, the clinician will notify the study team. The study team will review this information and evaluate whether the event could reasonably be attributed to the R&R or TAU intervention or participation in the trial. All instances of adverse events will be reviewed as to whether or not they are considered to be attributable to the interventions (R&R vs TAU) or trial, and, based on this information, determine whether the participant should be withdrawn and/or if the trial should continue, be suspended or cease.

Treatment fidelity

The R&R intervention will be delivered by an experienced psychotherapist (AB) who has already been trained in R&R delivery. The therapist will be supervised by VA and DM for the duration of the study. A selection of treatment sessions will be audio recorded and assessed for treatment integrity and fidelity.

Ethics and dissemination

We will share a summary of trial outcomes with veteran patients and disseminate the findings widely to reach a variety of stakeholders. For example, we will publish study outcomes in open-access articles in journals to reach academic and clinical audiences; present findings at both national and international conferences; create tailored reports for policy-makers and care providers; and share findings via our institutional website, newsletters, blogs and social media platforms.

This trial, which was reviewed and approved by King’s College London Research Ethics Committee, aims to explore the feasibility and acceptability of delivering a targeted psychological therapy (R&R) to veterans presenting with moral injury-related mental health difficulties, compared with current usual treatment provision. If R&R is found to be feasible, well tolerated and beneficial, R&R may improve access to effective interventions for those who struggle following moral injury and reduce the associated negative consequences for veterans, their families and wider society.

Trial status

Participant recruitment and treatment is expected to begin in July 2023 and continue until December 2024.