Title: Pilot study to inform a randomised control trial protocol examining the clinical effectiveness of a modified version of Interpersonal Psychotherapy (IPT-BNm) for the treatment of bulimia nervosa
Funder: Department of Health (England)

Abstract: Aim of this pilot: We would like to propose a pilot study that will inform the development of a randomized control trial comparing CBT-BN with IPT BNm. This pilot study will randomly allocate 40 patients with bulimia nervosa to one of two psychological treatments; cognitive behavioural therapy for bulimia nervosa (CBT-BN) versus interpersonal psychotherapy for bulimia nervosa modified version (IPT-BNm). The outcomes of this pilot will inform the design of a subsequent randomized control trial to assess whether IPT-BNm is better than CBT-BN in reducing bulimic psychopathology post therapy and at six month follow up. Method: We will use a randomised controlled designed as per the RCT, aiming at comparing IPT BNm (intervention group) with NICE recommended treatment (CBT-BN). Participants will be recruited from two NHS eating disorders outpatient services: Nottingham and Leicester. This pilot study will assess whether: there are adequate numbers of eligible patients willing to be randomised to the alternative therapies; clinicians from the two participating centres are willing to recruit to the study and for their patients to be randomised to study arms; patient withdrawal rates from the study are acceptably low; the standard deviation of primary outcome measures indicates that a subsequent trial with sufficient power is achievable; that outcome measure completion rates are sufficiently high. In the subsequent main trial, the primary outcome measures will be Reduction of mean weekly binges and vomiting episodes. Reduction in levels of eating psychopathology using the EDE-Q Global score. The secondary outcomes will be: Self-reported levels of depression and anxiety Quality of life Self-reported interpersonal problems Experimental design: The proposed study will comprise of a pilot of a randomised controlled trial to compare IPT-BNm to CBT-BN. Participants will be randomly assigned by an external CI (CIE) using an SPSS function according to CONSORT guidelines to two groups: IPT-BNm -20 sessions CBT-BN -20 sessions weekly Participants and Recruitment: Participants at both sites will be recruited from referrals to the chief investigator at their respective practices. Screening & allocation process: 1. Initial contact will be by clinic referral. Screening at the clinical assessment will identify those patients who meet eligibility criteria. 2. Those deemed eligible will be provided with a basic overview of the study and then offered the possibility of more detailed information. 3. Those who express a wish to know about the study will meet with the research assistant who will explain the project in detail, including giving the patient written information about the project. The patient will be contacted subsequently (48 hours later) to identify whether they would like to participate in the study. 4. If the patient agrees to participate, an initial assessment will be scheduled which will include obtaining informed consent. 5. Assessment. 6. Randomisation will use an Excel Program, Ephron’s Biased Coin and will be stratified by location (Nottingham or Leicester) subtype of illness (BN vs atypical BN), whether a participant is on psychotropic medication, and whether a participant has or has not received previous psychotherapy for BN within the previous 12 months. All assessments will be conducted by assessors blind to treatment group. Analysis: The pilot data will be used to determine whether a subsequent definitive trial is feasible or not. Measurements Diagnosis (EDE) Eating disorder symptomatology (EDE-Q, Diaries) Depression and Anxiety (HADS) Quality of life


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH