Personality disorder Mental and Behavioural Disorders
Conditions
Interventions
This is a multicentre, individually randomised, parallel-group, researcher-masked, randomised controlled trial, including a parallel process evaluation and an integrated economic evaluation.
The tria
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 31/08/2023: 1. Probable personality disorder on the Standardised Assessment of Personality Abbreviated Scale (score of 4 or more) 2. Age 18 years old and over 3. Being treated by mental health staff working in a primary or secondary care NHS setting Process evaluation: 4. Involved in the trial in any way or have indicated an interest in talking about their reasons for declining as part of the process evaluation if they declined when initially approached Previous inclusion criteria: Trial involvement: 1. Age 18 years old and over 2. Being treated by mental health staff working in a primary or secondary care NHS setting Process evaluation: 3. Involved in the trial in any way or have indicated an interest in talking about their reasons for declining as part of the process evaluation if they declined when initially approached
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 31/08/2023: 1. Unable or unwilling to provide written informed consent 2. Co-existing organic or psychotic mental disorder 3. In receipt of psychological treatment for personality disorder or are on a waiting list of <1 year for such treatment 5. Anyone currently a participant in a clinical trial or other interventional research will not be eligible to take part until their participation is complete Previous exclusion criteria: 1. Probable personality disorder on the Standardised Assessment of Personality Abbreviated Scale 2. Unable or unwilling to provide written informed consent 3. Co-existing organic or psychotic mental disorder 4. In receipt of psychological treatment for personality disorder or are on a waiting list for such treatment 5. Anyone currently a participant in a clinical trial or other interventional research will not be eligible to take part until their participation is complete.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Social functioning measured using the Work and Social Adjustment Scale total score at 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mental health measured using the 16-item Difficulties in Emotion Regulation Scale, the nine-item Patient Health Questionnaire, and the seven-item Generalised Anxiety Disorder scale at 6 and 12 months 2. Suicidal thoughts and behaviour measured using items from the National Household Survey of Psychiatric Morbidity scale at 6 and 12 months 3. Health-related quality of life measured using the EQ-5D-5L at 6 and 12 months 4. Patient experience measured using the patient-rated Global Improvement scale and the patient-rated Satisfaction with Care scale at 6 and 12 months 5. Personality status measured using the Standardised Assessment of Personality – Abbreviated Scale at 6 and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactTrial Coordinating Office
Outcome results
None listed