Mentalization-Based Treatment - Trauma Focused (MBT-TF) trial
Research type
Research Study
Full title
Randomized Controlled Trial to compare clinical effectiveness and cost-effectiveness of Mentalization-Based Treatment - Trauma Focused (MT-TF) versus Treatment as Usual (TAU) for people with probable complex post-traumatic stress disorder in mental health services in England
IRAS ID
340141
Contact name
Tobias Nolte
Contact email
Sponsor organisation
North London Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Background: To date, treatments that effectively address both the symptoms of complex trauma and personality difficulties that characterise CPTSD are rare. The burden of CPTSD in the UK includes significant psychiatric comorbidity, chronic illness, and a elevated risk of suicide. MBT-TF aims to directly address the impact of trauma in a complex presentation and alleviate patient's distress in tailored, inclusive, non-stigmatising and non-discriminating treatment pathways that mitigate the risk of drop out by integrating trauma processing.
Research question:Research question: Is MBT-TF more effective than treatment as usual (TAU) in reducing symptoms of CPTSD (primary outcome) in adults meeting diagnostic criteria for CPTSD?
Design: Multi-site phase 2 superiority single-blind RCT. Participants will be followed up at 3, 9 and 15 months post randomisation.
Setting: 10 NHS Personality Disorder services in England and Wales
Target population: Aged 18-65 years old; meet PTSD criteria on the ITQ with a least one symptom from each DSO cluster, with functional impairment associated with these symptoms as assessed by the ITQ at screening equivalent to CPTSD diagnosis; scoring >31 on the LPFD at screening and sufficient knowledge of the English language.
Intervention: Participants randomised to MBT-TF will receive weekly group therapy sessions lasting 90 minutes. Treatment will involve approximately 36 groups session and up to 5 individual supportive therapy sessions as needed over a 9 month period.
REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0137
Date of REC Opinion
7 Mar 2025
REC opinion
Further Information Favourable Opinion