Borderline personality disorder Mental and Behavioural Disorders Emotionally unstable personality disorder
Conditions
Interventions
Randomisation will be via a secure online randomisation system, at an individual level, stratified by centre. Those in the active arm of the trial will be offered perinatal ESGs in addition to standar
these skills can be taught and practiced both prenatally, as well as postnatally. The groups will be run by a clinical psychologist working with a trained nurse or other qualified perinatal clinician.
Sponsors
University of Bristol
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Participants will meet the following inclusion criteria: 1. At least 18 years old 2. Likely to have a diagnosis of borderline personality disorder 3. Either pregnant (from week 15 gestation onwards) or are within 12 months of having a live birth
Exclusion criteria
Exclusion criteria: Women will be excluded if: 1. They have a current clinical diagnosis of a co-existing organic, psychotic mental disorder or substance use dependence syndrome 2. They have cognitive or language difficulties that would preclude subjects providing informed consent or compromise participation in study procedures 3. They pose an acute risk to their baby, as assessed by clinicians 4. They require admission to a mother and baby unit 5. They are unable to speak English with sufficient fluency to participate in study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of recruitment: 1. Appropriateness of eligibility criteria, as measured by the number of those referred to the trial over the study period who meet the eligibility criteria 2. Success of recruitment, as measured by the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate (including reasons for non-participation) 3. Retention rates, as measured by the number of participants who consent to participate that remain in the trial by the 4-month follow-up Feasibility of measures: 1. Baseline measures: the number/proportion of participants with complete baseline data over the study period 2. Follow-up measures: the number/proportion of participants with complete follow-up data at the 4-month follow-up Feasibility of the intervention as measured by 1. The number/proportion of participants attending all 12 sessions of treatment during the treatment phase of the study 2. The number/proportion of participants attending at least 9 sessions of treatment during the treatment phase of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of borderline personality disorder measured using the Zanarini Rating Scale for Borderline Personality Disorder Self-Report Scale (ZAN-BPD), at 2 and 4 months post-randomization 2. Symptoms of psychological distress measured using the ten-item Clinical Outcomes in Routine Evaluation (CORE-10) at 2 and 4 months post-randomization. 3. Health-related quality of life measured using the EQ-5D-5L at 4 months post-randomization. 4. Mental wellbeing measured using the Short Warwick Edinburgh Wellbeing Scale (SWEMWBS) at 2 and 4 months post-randomization 5. Social functioning measured using the Work and Social Adjustment Scale (WSAS), at 2 and 4 months post-randomization 6. Parenting stress measured using the Parental Stress Scale at 2 and 4 months post-randomization 7. Self-harming behaviour over the past week measured using a single question: “Have you [in the past week] deliberately taken an overdose (e.g., of pills or other medication) or tried to harm yourself in some other way (such as cut yourself)?”. This will be assessed at 2 and 4 months post-randomization. 8. Resource use will be measured by maternal self-report at 4 months post-randomisation 9. Data about the baby’s growth (weight and height) and vaccination status will be sourced from Personal Child Health Records at 4-months post-randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed