Robinson 2016.

Study characteristics
Methods	1‐year trial with 2 arms Mentalisation‐based treatment for eating disorders (MBT‐ED) Specialist supportive clinical management for eating disorders (SSCM‐ED) Duration of trial: 1 year Country: UK Setting: outpatient
Participants	Method of recruitment of participants: participants recruited from clinical centres by referral from doctors working in the outpatient services of each centre. Referrals received by trial manager, who contacted the potential participant and provided the participant information sheet. Sample size: 68 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV) Means of assessment: Structured Clinical Interview for DSM‐IV Axis II Disorders (SCID‐II) Mean age: 31.1 years (standard deviation = 9.9) Sex: 92.7% female Comorbidity: anorexia = 5.9%, bulimia = 63.2%, binge eating disorder = 2.9%, eating disorder not otherwise specified (EDNOS) = 27.9% Inclusion criteria Aged 18 years or older Had a DSM‐IV diagnosis of an eating disorder Fulfilled either DSM‐IV criteria for borderline personality disorder or had borderline personality disorder symptoms. The criteria for borderline personality disorder symptoms were both of the behavioural criteria of DSM‐IV. Impulsivity in at least 2 areas that are potentially self‐damaging (e.g. spending, sexual behaviour, substance abuse, reckless driving, binge eating) Recurrent suicidal behaviour or self‐mutilating behaviour Exclusion criteria Current psychosis based on the Mini International Neuropsychiatric Schedule (MINI) examination Current inpatient or day‐patient (attending 3 or more days per week) Currently in individual or group psychological therapy Received MBT less than 6 months prior to randomisation Organic brain disease leading to significant cognitive impairment or body mass index (BMI) less than 15 kg/m2 (normal range = 18.5–25)
Interventions	Experimental group Treatment name: mentalisation‐based treatment for eating‐disorders (MBT‐ED) Number randomised to group: 34 Duration: 1 year Control/comparison group Comparison name: specialist supportive clinical management for eating disorders (SSCM‐ED) Number randomised to group: 34 Duration: 1 year Both groups Concomitant psychotherapy: no (excluded if currently in individual or group psychological therapy) Concomitant pharmacotherapy: not stated Proportions of participants taking standing psychotropic medication during trial observation period: unclear
Outcomes	Primary Borderline personality disorder severity, assessed by the Zanarini Rating Scale for Borderline Personality Disorder (ZAN‐BPD) Mental health status, assessed by the Global Assessment of Functioning Scale (GAF) Secondary Affective instability, assessed by the relevant item or subscale on the ZAN‐BPD Chronic feelings of emptiness, assessed by the relevant item or subscale on the ZAN‐BPD Impulsivity, assessed by the relevant item or subscale on the ZAN‐BPD Interpersonal problems, assessed by the relevant item or subscale on the ZAN‐BPD Abandonment, assessed by the relevant item or subscale on the ZAN‐BPD Identity disturbance, assessed by the relevant item or subscale on the ZAN‐BPD Depression, assessed by The Depression, Anxiety and Stress Scale ‐ 21 Items (DASS‐21) Attrition, in terms of patients lost after randomisation in each group Adverse effects, measured by spontaneous reporting
Notes	Sample size calculation: yes Ethics approval: yes Comments from review authors: We received additional subsample data on BPD patients only at two time points by email from Dr Hellier on 3 January and 27 March 2018.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “The method of randomisation of participants was block randomisation stratified by BMI (15.0–18.5, 18.6–24.9, 25).” (p 552)
Allocation concealment (selection bias)	Unclear risk	Quote: “Randomly varying block sizes were implemented in order to maintain pre randomisation allocation concealment. The trial manager used the randomisation result to allocate participants to a treatment.” (p 552)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: “single‐blind (researchers and statisticians are blind)”, “the trial statistician and research workers responsible for the collection of the assessments remained blind to treatment allocation during the trial and primary analyses.” (p 550)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: 15/35 in SSCM‐ED and 5/34 in MBT‐ED did not receive interventions – significant differences. Reasons were similar across groups. 41/61 participants were included in the analyses, so this can be said to be a partial ITT analysis. Did not comply with the level of attendance calculated a priori. Quotes: “Participants allocated to SSCM‐ED were significantly more likely to drop out before the start of therapy than those allocated to MBT‐ED.” (p 15) "We set a level of 50% attendance [10] to indicate compliance. That level was achieved by 47.1 % in the MBT‐ ED arm and 37.1% in the SSCM‐ ED arm". (p 556)
Selective reporting (reporting bias)	Low risk	Quote: "Not all questionnaires and interviews anticipated in the protocol were included in this analysis. Some were excluded because the small numbers remaining at follow‐up did not justify statistical analysis of outcome over time, and others (the Object Relations Inventory (ORI), treatment adherence, Reading the Mind in the Eyes test and the Reflective Uncelar – they do not use all but it makes sense in statistical terms. Functioning Questionnaire (RFQ)) will be de‐scribed elsewhere". (p 563)
Other bias	High risk	Adherence bias Quotes: “Adherence to the treatment model was tested by the supervisors. After the trial, seven recorded and transcribed sessions each of MBT‐ED (individual therapy, four therapists) and SSCM‐ED (seven therapists) were randomly selected and subjected to adherence rating.” (p 552) "The adherence scores (with number of sessions scoring that level in brackets) were 7 (1), 6 (3), 4 (3). Competence scores were identical to adherence scores". (p 552) Allegiance bias Comment: trial was conducted with support from A Bateman Attention bias Comment: total number of hours in MBT‐ED was 102.7 hours over 12 months; total number of hours in SSCM‐ ED was 20‐26 hours over 12 months.