Supported online cognitive behavioural therapy for bulimia nervosa: a study protocol of a randomised controlled trial

Abstract

Background Despite the availability of effective treatments for bulimia nervosa (BN), a number of barriers to accessibility exist. Examples include access to trained clinicians, the expense of treatment, geographical limitations, and personal limitations such as stigma regarding help seeking. Self-help interventions, delivered via a digital platform, have the potential to overcome treatment gaps by providing patients with standardised, evidence-based treatments that are easily accessible, cost-effective, and require minimal clinician support. Equally, it is important to examine the shortcomings of digital interventions when compared to traditional to face-to-face delivery (e.g., high dropout rates) in order to maximise the therapeutic effectiveness of online, self-help interventions. Methods A three-arm, multisite randomised controlled trial will be conducted in Australia examining the effectiveness and cost-effectiveness of a newly developed online self-help intervention, Binge Eating eTherapy (BEeT), in a sample of patients with full or sub-threshold BN. The BEeT program consists of 10, multimedia sessions delivering the core components of cognitive behaviour therapy. Eligible participants will be randomised to one of three groups: independent completion of BEeT as a purely self-help program, completion of BEeT alongside clinician support (in the form of weekly telemedicine sessions), or waitlist control. Assessments will take place at baseline, weekly, post-intervention, and three-month follow up. The primary outcome is frequency of objective binge episodes. Secondary outcomes include frequency of other core eating disorder behavioural symptoms and beliefs, psychological distress, and quality of life. Statistical analyses will examine treatment effectiveness, feasibility, acceptability and cost effectiveness. Discussion There is limited capacity within the mental health workforce in Australia to meet the demand of people seeking treatment for eating disorders. This imbalance has only worsened following outbreak of the COVID-19 pandemic. Further research is required into innovative digital modes of treatment delivery with the capacity to service mental health needs in an accessible and affordable manner. Self-help programs may also appeal to individuals who are more reluctant to engage in traditional face-to-face treatment formats. This study will provide rigorous evidence on how to diversify treatment options for individuals with BN, ensuring more people with the illness can access evidence-based treatment. The study has been registered with the Australia New Zealand Clinical Trials Registry (ANZCTR Registration Number: ACTRN12619000123145p). Registered 22 January 2019, https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12619000123145.

Evaluating the feasibility and potential efficacy of a brief eTherapy for binge‐eating disorder: A pilot study

“…Fifty‐five women expressed interest, with 19 women entering the study (Figure S1 ). Those interested were assessed via a 20‐min screening call with a trained researcher using self‐designed questions (Barakat et al, 2021 ), with eligibility confirmed in an online assessment at baseline (Figure S2 ). Participants were required to have experienced one or more weekly objective binge episodes in the preceding two months (i.e., subthreshold BED), with those experiencing this frequency in the preceding three months considered BED, as per DSM‐5 criteria (American Psychiatric Association, 2013 ).…”

“…The duration of Brief SSH‐BEeT was approximately four‐weeks. Risk associated with participation was low; however, given the clinical population, participant safety was managed via established trial procedures (Barakat et al, 2021 ).…”

Using Digital Tools in Clinical, Health and Social Care Research: A Mixed-Methods Study of UK Stakeholders

“…This mixed-method study aimed to explore which tools are being used across clinical research as well as staff experiences of digital tool use. Our findings indicate that digital tools are now a fundamental part of clinical research; the COVID-19 pandemic accelerated the use of tools with adoption observed across all research stages (e.g., 1, 11–13). Tools were mostly viewed favourably, with increased efficiency cited as a leading benefit for research staff.…”

The use of technology in the treatment of youth with eating disorders: A scoping review

“…There were two protocols outlining RCTs to evaluate the smartphone apps, Recovery Record [ 65 ] and Jourvie Research app [ 62 , 63 ] for participants with AN. A third study proposed an RCT evaluating a CBT-based self-help program, with and without therapist support, for participants with BN [ 57 ]. A fourth RCT proposed to evaluate the fully automated, online psychoeducation program Featback , comparing groups with and without expert patient support [ 64 ].…”

“…Scores for EDE-Q decreased by 7–12 point Duncan et al [ 55 ] Case study N = 1 Sex = female Age = 14 years Diagnosis = EDNOS Recruited from rural tele-psychological clinic in her community USA NR Videoconference delivered therapy, based on cognitive behavioral strategies Online: all sessions done over videoconferencing platform. 1 appointment was done in person No additional support outside of primary treatment n/a At the end of the 12 sessions of therapy, Mila increased food intake, fell within normal range on growth chart, and scores on CDI no longer elevated Study protocols* Anderson et al [ 56 ] Case series N = 10 (target) Age range = 13–18 years Sex = no specification Diagnosis = DSM-5 criteria for AN or atypical AN Recruited = by referrals and through community USA NR Videoconference delivered Family-Based Treatment consisting of weekly family meetings with therapist (20 sessions over 6 months) Online: intervention delivered completely via telehealth platform No additional support outside of primary treatment Feasibility/Acceptability of FBT via Telemedicine Protocol only Barakat et al [ 57 ] Multi-site three-arm RCT N = 110 (target) Gender will be reported Age range ≥ 16 years Diagnosis = DSM-5 criteria for BN or OSFED with bulimic behaviors Recruited = from general population via advertisement and referrals from health professional Australia Income, and cultural background/ethnicity will be reported Online CBT-based self-help program completed independently vs. completed with therapist guidance (= weekly telemedicine sessions) vs. waitlist control Online: either online self-help platform or secure videoconference platform For self-help group with guidance only: weekly 30 min videoconference session with therapist Frequency of objective binge...…”