Perinatal emotional skills groups for women with borderline personality disorder

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: 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 standard perinatal mental health care, while those in the control arm will continue to receive standard perinatal mental health. Perinatal ESGs comprise two individual preparatory sessions, followed by 12 group sessions. The individual sessions will last up to 90 minutes and subsequent group sessions last up to 2 hours. Participants receiving ESGs will also continue to be cared for as usual by their perinatal mental health team. Groups usually treat up to si Xwomen and the groups are organised into four modules on emotion regulation, distress tolerance, mindfulness and interpersonal effectiveness. These modules are focused on the acquisition of emotional skills and each session is supplemented with “Keeping Baby in Mind” teaching skills relevant to becoming a parent of a new child; 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. The comparator treatment will be standard perinatal mental health care, delivered on an individual basis, in accordance with current NICE and Royal College of Psychiatry guidelines. It should consist of an assessment, a written care plan and weekly reviews with a care coordinator. All study participants allocated to receive the comparator treatment will complete all the study assessments. Information on standard care will be gathered at the follow‐up assessment, 4 months post‐randomisation. CONDITION: Borderline personality disorder ; Mental and Behavioural Disorders ; Emotionally unstable personality disorder PRIMARY OUTCOME: 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 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 SECONDARY OUTCOME: 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
Epistemonikos ID: 05e68b8c8eb734bc175ff79cd9c0c18bb5ae0fab
First added on: Aug 25, 2024