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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92005743

Enrollment

198

Registered

2025-09-19

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-09-29

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

Conditions

Complex post-traumatic stress disorder (CPTSD) Mental and Behavioural Disorders

Interventions

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 ther

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Current psychotic episode 2. Diagnosis of severe neurological disorder

Design outcomes

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Primary

Measure	Time frame
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).	—

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactElizabeth Simes

e.simes@ucl.ac.uk+44 (0)2076792000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026