Mentalization-based therapy for individuals with probable complex post-traumatic stress disorder

ISRCTN	ISRCTN92005743
DOI	https://doi.org/10.1186/ISRCTN92005743
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	340141
Protocol serial number	Nil known
Sponsor	Noclor
Funder	University College London

Submission date: 27/05/2025
Registration date: 19/09/2025
Last edited: 19/09/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
To date, treatments that effectively address both the symptoms of complex trauma and personality difficulties that characterise complex post-traumatic stress disorder (CPTSD) are rare. The burden of CPTSD in the UK includes significant psychiatric comorbidity, chronic illness, and an elevated risk of suicide. Mentalization-Based Treatment - Trauma Focused (MT-TF) aims to directly address the impact of trauma in a complex presentation and alleviate patients' distress in tailored, inclusive, non-stigmatising and non-discriminating treatment pathways that mitigate the risk of drop out by integrating trauma processing. This study aims to compare MBT-TF with TAU for adults meeting the diagnostic criteria for CPTSD in personality disorder services.

Who can participate?
Males, females, individuals who do not identify as male or female, aged 18 - 65 years old, who meet PTSD criteria with sufficient knowledge of the English language.

What does the study involve?
Participants are randomised to MT-TF or Treatment as Usual (TAU). Participants randomised to MBT-TF will receive weekly group therapy sessions lasting 90 minutes. Treatment will involve approximately 36 group sessions and up to 5 individual supportive therapy sessions as needed over a 9-month period. Baseline data will be collected pre-randomisation. Participants will be followed up at 3, 9 and 15 months post-randomisation.

What are the possible benefits and risks of participating?
There is minimal risk from randomisation and treatment to the participants themselves. Both MBT-TF and TAU will be delivered by experienced professionals used to working with this client group. Those who agree to participate in the trial will be involved in a number of time-consuming interviews and assessments, which may be somewhat burdensome but do not carry specific risk. The researchers are experienced in conducting assessments and encourage regular breaks to be taken by the participant if necessary. By agreeing to take part, the participant will receive a treatment intervention that would not normally be offered. The outcomes of the evaluation could also improve the provision of interventions for other patients.

Where is the study run from?
North London NHS Foundation Trust is sponsoring the study and University College London is the lead.

When is the study starting and how long is it expected to run for?
March 2025 to June 2028

Who is funding the study?
University College London (UK)

Who is the main contact?
1. Dr Tobias Nolte, Tobias.NolteMD@annafreud.org
2. Prof. Patrick Luyten, p.luyten@ucl.ac.uk

Contact information

Dr Tobias Nolte
Scientific, Principal investigator

North London Foundation Trust
St Pancras Hospital in Camden
London
NW1 0PE
United Kingdom

Phone	+44 (0)20 8702 3000
Email	Tobias.NolteMD@annafreud.org

Prof Patrick Luyten
Scientific, Principal investigator

University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

ORCID ID	0000-0002-1161-2817
Phone	+44 (0)2076792000
Email	p.luyten@ucl.ac.uk

Dr Elizabeth Simes
Public

University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

ORCID ID	0000-0003-1704-6278
Phone	+44 (0)2076792000
Email	e.simes@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-site superiority single-blind randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomized controlled trial to compare clinical effectiveness and cost-effectiveness of mentalization-based treatment - trauma focused versus treatment as usual for people with probable complex post-traumatic stress disorder in mental health services in England
Study acronym	MBT-TF
Study objectives	The aim of this study is to conduct a randomised controlled trial (RCT) to investigate whether Mentalization-Based Treatment - Trauma Focused (MT-TF) is an effective treatment for individuals who meet threshold for diagnostic criteria for complex post-traumatic stress disorder (CPTSD) in personality disorder (PD) services compared to Treatment as Usual (TAU).
Ethics approval(s)	Approved 07/03/2025, London - Hampstead Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 104 8284; hampstead.rec@hra.nhs.uk), ref: 25/LO/0137
Health condition(s) or problem(s) studied	Complex post-traumatic stress disorder (CPTSD)
Intervention	Participants are randomised (minimization, 1:1) to Mentalization-Based Treatment - Trauma Focused (MT-TF) or Treatment as Usual (TAU). Participants randomised to MBT-TF will receive weekly group therapy sessions lasting 90 minutes. Treatment will involve approximately 36 group sessions and up to 5 individual supportive therapy sessions as needed over a 9-month period. Participants will be followed up at 3, 9 and 15 months post-randomisation.
Intervention type	Behavioural
Primary outcome measure(s)	Symptoms of complex post-traumatic stress disorder (CPTSD) assessed by the International Trauma Questionnaire (ITQ) at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4).
Key secondary outcome measure(s)	1. Diagnosis of Borderline personality disorder will be measured by the Borderline Symptom List at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 2. Childhood trauma will be measured by the Childhood Trauma Questionnaire at baseline (T1) only. 3. Disturbance, impulsivity, severity of personality disorder, global functioning, social functioning, interpersonal functioning, suicide ideation and behaviour, sense of belonging, self-care, emotional distress and health related quality of life will be measured by the International Consortium for Health Outcomes Measurement Personality Disorder List at Collected at baseline (T1), 9 month follow up (T3) and 15 month follow up (T4). 4. Diagnosis of PTSD will be measured by the Clinician Administered PTSD Scale for DSM-5 at baseline (T1), 9 month follow up (T3) and 15 month follow up (T4) and Clinician Administered PTSD Scale for DSM-5 at baseline (T1), 9 month follow up (T3) and 15 month follow up (T4). 5. Levels of personality functioning will be measured by the Level of Personality Functioning Screener-Brief Form at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 6. Interpersonal difficulties will be measured by the Inventory of Personal Problems at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 7. Quality of life will be measured by the EQ-5D-5L at baseline (T1), 9-month follow-up (T3) and 15 month follow up (T4). 8. Dissociative experiences will be measured by the Dissociative Experiences Scale-II at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 9. Psychological distress and psychiatric disorder will be measured by the Brief Symptom Inventory 18 at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 10. Individual's feeling of loneliness will be measured by the UCLA Loneliness Scale Short Form at baseline (T1), 9-month follow-up (T3) and 15 month follow up (T4). 11. Trust in communicated knowledge will be measured by the Epistemic Trust, Mistrust and Credulity Questionnaire at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 12. Reflective functioning will be measured by the Reflective Functioning Questionnaire at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4) 13. Indicators of failures in mentalizing trauma and adverse relationships will be measured by the Failure to Mentalize Trauma Questionnaire at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 14. Patient experiences will be measured by the Helping Alliance Questionnaire at baseline (T1) and 9-month follow-up (T3) and Client Satisfaction Questionnaire at 9-month follow-up (T3) only. 15. Feelings of shame related to experiencing traumatic events will be measured by the Trauma-Related Shame Inventory at Baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4). 16. Service use will be measured by the Adult Service Use Schedule at baseline (T1), 9-month follow-up (T3) and 15-month follow-up (T4). 17. Post-traumatic growth will be measured by the Posttraumatic Growth Inventory - Expanded at baseline (T1), 3-month follow-up (T2), 9-month follow-up (T3) and 15-month follow-up (T4).
Completion date	01/06/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	198
Key inclusion criteria	1. Aged 18-65 years 2. Meeting PTSD criteria on the ITQ in combination with at least one symptom from each Disturbances in Self-Organization (DSO) cluster, with functional impairment associated with these symptoms as assessed by the ITQ at screening equivalent to CPTSD diagnosis. 3. Scoring ≥31 on the LPFS-BF (36) at screening, which corresponds to 1.5 standard deviations above the latent mean (T score of 65), indicating at least moderate severity in terms of personality disorder features. 4. Sufficient knowledge of the English language.
Key exclusion criteria	1. Current psychotic episode 2. Diagnosis of severe neurological disorder
Date of first enrolment	01/06/2025
Date of final enrolment	01/08/2026

Locations

Countries of recruitment

United Kingdom
England
Scotland
Wales

Study participating centres

Oxleas NHS Foundation Trust

Pinewood House
Pinewood PLACE
Dartford
DA2 7WG
United Kingdom

Merseycare NHS Trust

V7 Building
Kings Business Park
Prescot
L34 1PJ
United Kingdom

Kent and Medway NHS and Social Care Partnership Trust

Farm Villa
Hermitage Lane
Maidstone
ME16 9PH
United Kingdom

Greater Manchester Mental Health NHS Foundation Trust

Prestwich Hospital
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom

South London and Maudsley NHS Foundation Trust

Bethlem Royal Hospital
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom

Avon and Wiltshire Mental Health Partnership NHS Trust

Bath NHS House
Newbridge Hill
Bath
BA1 3QE
United Kingdom

Devon Partnership NHS Trust

Wonford House Hospital
Dryden Road
Exeter
EX2 5AF
United Kingdom

South West London and St. George's Mental Health NHS trust

Springfield Hospital
61 Glenburnie Road
London
SW17 7DJ
United Kingdom

Barnet, Enfield and Haringey Mental Health NHS Trust

Trust Headquarters
Block B2
St Ann's Hospital
St Ann's Road
London
N15 3TH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated for this study will be stored on secure systems at University College London in line with ethical approvals and data protection guidelines. Patient-level data will not be made available due to the sensitive nature of the data collected.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/05/2025: Study's existence confirmed by the London - Hampstead Research Ethics Committee.