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Be Part of Research - Trial Details - R&R: A trial for moral injury related mental health difficulties

R&R: A trial for moral injury related mental health difficulties

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Moral injury related mental health difficulties in UK military veterans.


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


No manualised treatment for moral injury (MI) related mental disorders exists. International studies argue that existing trauma treatments can be unhelpful - even harmful – for people whose mental disorders are linked to MI. UK clinicians report uncertainty about how to treat MI. UK veterans struggling after potentially morally injurious events (PMIEs) report that routine treatments (e.g. trauma focused cognitive behavioural therapy [TF-CBT]) do not fully address their symptoms.

We designed the Restore & Rebuild (R&R) treatment to treat MI-related mental disorders. R&R has been successfully piloted & preliminary results show improvement in patient functioning, no drop out & no adverse events. Patient interviews show R&R is well tolerated. The time is now right to further explore the efficacy of R&R in a phase 2 exploratory trial.

We will examine if it is feasible & acceptable to pilot a randomised control trial (RCT) of R&R treatment compared to a treatment as usual (TAU) control group of UK veterans with MI-related mental disorders.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Jul 2023 01 Jul 2026

Publications

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38754887/ (added 21/05/2024)

Taking part involves receiving a psychological therapy provided by a qualified psychotherapist at Combat Stress. This will be either the standard treatment for moral injury that Combat Stress currently delivers (TAU) or the new moral injury treatment (R&R) created by the research team. Before and after treatment patients will be invited to complete questionnaires about their thoughts and feelings and some will be invited to take part in an interview about their experiences of receiving treatment.

Where is the study run from?
The study is a joint project between King's College London and Combat Stress (UK). All treatment will be delivered at Combat Stress.


UK military veterans who are experiencing mental health difficulties following a morally injurious event during military service are eligible to participate.

You can take part if:



You may not be able to take part if:


Veteran patients: For veteran patients who will receive R&R and TAU, no limitations on eligibility according to demographic characteristics (e.g. gender, age, rank) will be imposed. Moreover, we will not restrict participation by deployment location or military service branch.

We will exclude veteran participants: 1. Who are not aged 18 years or more2. Who do not have military-attributable moral injury-related mental health problems as determined by their clinician3. Have speech or hearing difficulties or serious cognitive impairment 4. Are actively self-harming or expressing significant suicidal ideation5. Are unwilling or unable to provide informed consent6. Have received trauma-focused individual therapy within last 3 months or have planned concurrent psychological therapy treatment7. Who present with severe psychotic disorder (including in previous clinical diagnosis)8. Who are experiencing dissociative identity disorder or other severe mental health difficulty 9. Who are currently experiencing significant life stressors that would impair the participant’s ability to engage in therapy (e.g. homelessness)10. Who have current alcohol or drug use disorder or dependency requiring further support or treatment that would significantly impact treatment engagement, as assessed by clinician 11. Who do not have internet access or are unwilling to complete sessions remotely12. Who participated in the R&R pilot trial and previously received R&R (added 20/06/2023)

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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Combat Stress
    Combat Stress Tyrwhitt House Oaklawn Road
    Leatherhead
    KT22 0BX

There is no direct intended benefit to taking part. In terms of possible risks, engaging in therapy can be emotionally challenging at times. However, it is normal to feel some distress during therapy and these emotional responses are often a necessary part of treatment and recovery. The therapists in both study arms will be trained and experienced in supporting individuals through these difficult thoughts and emotions and will work with patients to help them manage these feelings. If, at the end of the treatment, a patient feels that they are in need of further support, treatment referral and support options can be arranged.


The study is sponsored by Forces in Mind Trust and funded by Forces in Mind Trust.




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Read full details for Trial ID: ISRCTN99573523
Last updated 21 May 2024

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