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

R&R: A phase 2 randomised controlled trial for moral injury related mental health difficulties

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN99573523
Enrollment
46
Registered
2023-06-19
Start date
2023-07-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moral injury related mental health difficulties in UK military veterans. Mental and Behavioural Disorders

Interventions

Intervention = Restore & Rebuild (R&R) Control = treatment as usual (TAU). R&R Treatment: R&R is a manualised therapy treatment, there are 20 treatment sessions in total, delivered one-to-one betwee
typically following a Cognitive Behavioural or Cognitive Processing Therapy model. Details of the TAU intervention provided to all TAU participants will be recorded as part of the study. Randomisatio

Sponsors

Forces in Mind Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Veteran patients: The veteran must demonstrate presence of a military-attributable moral-injury related mental health difficulty confirmed via clinician assessment. Veteran participants must be willing to provide informed consent to participate in the study and consent to share treatment information with their GP as required.

Exclusion criteria

Exclusion criteria: 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 more 2. Who do not have military-attributable moral injury-related mental health problems as determined by their clinician 3. Have speech or hearing difficulties or serious cognitive impairment 4. Are actively self-harming or expressing significant suicidal ideation 5. Are unwilling or unable to provide informed consent 6. Have received trauma-focused individual therapy within last 3 months or have planned concurrent psychological therapy treatment 7. 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 remotely 12. 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.

Design outcomes

Primary

MeasureTime frame
1. PTSD will be assessed via PCL-5 (Weathers et al., 2013) at baseline and 3-months post-treatment 2. Moral Injury-related Distress via MIOS (Litz et al., 2022) and MORIS (Williamson et al., under review) at baseline and 3-months post-treatment

Secondary

MeasureTime frame
Measures will be administered at baseline, 3- months and 6- months post-treatment. 1. Complex PTSD measured via International Trauma Questionnaire (ITQ). 2. The Patient Health Questionnaire (PHQ9) to measure symptoms of depression. 3. The Dimensions of Anger Reactions scale (DARS-5) used to measure anger. 4. Alcohol Use Disorders Identification Test (AUDIT) to measure alcohol usage. 5. The Oslo Social Support Scale (OSSS-3) to measure perceived social support. 6. The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) to measure mental wellbeing. 7. The SF-12 to measure physical health. 8. A short measure of moral injury memory perspective will be included, adapted from Wells and Papageorgiou (1995).

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026