A randomised controlled trial evaluating the efficacy and mechanisms of online PeRinatal emOtional skillS groups compared to treatment as usual for women and birthing parents with borderline Personality disordER (PROSPER).
Specialty: Reproductive Health and Childbirth, Primary sub-specialty: General Obstetrics (antenatal and postnatal care, perinatal mental health); Health Category: Mental health, Reproductive health and childbirth; Disease/Condition: Mood [affective] disorders, Persons encountering health services in circumstances related to reproduction
Women and birthing parents, aged 18 years or over, meeting DSM-5 diagnostic criteria for BPD will be recruited. They will be allocated to receive emotional skills group (ESG) sessions plus standard perinatal mental health care, or standard perinatal mental health care alone, in a 1:1 ratio. Randomisation will be stratified by centre and minimised by perinatal stage and severity of BPD symptoms. The internal pilot, run across 3 sites, will establish whether sufficient numbers of eligible patients can be recruited, engage with their allocated treatment and whether sufficient primary outcome data can be obtained to robustly answer the trial questions. If the progression criteria are met, the main trial recruitment period will start at (at least) 7 sites. If the main trial proceeds, patients from the internal pilot will be included in the final analysis. All participants will be followed up for 1 year following the final randomisation within each cohort. Within each recruitment centre, potentially eligible patients will be identified from the existing caseload by the PI (or delegated member of the clinical team) for screening into the study. The PI (or delegated member of the clinical team) will introduce the study to potentially eligible patients during an in-person or remote consultation and will establish whether the patient agrees to being contacted by a member of the local research team. The PI (or delegated member of the team) will provide the patient with a copy of the participant information using a layered approach, and it will be explained that, if they agree to be contacted by a member of the local research team, then the first step involves participating in a screening interview to assess their eligibility to enter the trial. During the approach at the initial consultation, the PI (or delegated member of the clinical team) will record the relevant clinical eligibility checks on a screening CRF if the patient agrees to be contacted by the local research team
Participants may enter the study if ALL of the following apply: 1. Women and birthing parents aged 18 years or over who are pregnant (from week 12 gestation onwards) or within 12 months of having a live birth 2. Meet DSM-5 criteria for borderline personality disorder 3. Have internet access 4. Does not require an interpreter to facilitate clinical engagement 5. Provided informed consent for audio-recording of the ESG sessions (if allocated to the ESG group)
Participants may not enter the study if ANY of the following apply: 1. Those with psychosis, bipolar disorder or substance dependence 2. Those who pose a high risk to their baby or themselves 3. Those requiring admission to a psychiatric hospital 4. Those who are already receiving psychological treatment that is focused on personality or personality disorder symptoms