A Multimodal Outcome Study of Eating Disorders
Condition: Eating Disorder; Healthy
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This research project aims to explore the effectiveness of combined go/no-go training and
      implementation intentions in targeting binge eating frequency among people with binge eating
      disorder and bulimia nervosa.

      The full intervention is 4 weeks long and consists of completing the training and food
      diaries every day and meeting with the researcher twice for EEG recording. Moreover, it
      involves completing questionnaires at baseline, at intervention completion, and one month
      after the intervention.

      Moreover, healthy control participants will be recruitment to complete baseline
      questionnaires and take part in one EEG recording session in order to assess baseline
      differences in brain activation in response to computer tasks.
    

Detailed description: 
      Participants will learn about the study through flyers, e-mail, and social media (i.e.
      twitter and Facebook) which will describe the interventional nature of the study, the main
      eligibility criteria, and the researcher's contact information. Interested individuals will
      be asked to contact the researchers, who will then send an information sheet detailing the
      study procedure and what participation would involve. After reading the information sheet,
      interested individuals will be contacted by the researchers in order to confirm all
      eligibility criteria including diagnostic assessment. If these are met a PDF of the consent
      form will be sent to the participants, including information about their rights as
      participants and their ability to withdraw at any time without having to give a reason.
      Participants who sign the consent form will respond to the email with the attached document.
      Next, researchers will contact the participant to set an appointment to enter the lab for the
      first EEG recording. Before entering the lab, participants will be asked to complete a food
      diary and complete the complete a battery of questionnaires. The questionnaires include: 1) a
      demographic questionnaire, 2) eating disorders examination questionnaire, 3) food ratings
      test, 4) self-regulation of eating behaviour questionnaire for adults, 5) The negative
      urgency scale, 6) the adults eating behaviour questionnaire, 7) GAD-7, and 8) PHQ-9.

      Upon participants' arrival to the lab, participants will be asked to complete the food rating
      task. Next, they will learn to complete the training tasks (i.e. food specific go/no-go and
      general go/no-go) and perform them during EEG recording. They will be offered the opportunity
      to ask questions relating to the task or the EEG at any time. Their weight will also be
      measured.

      Participants will be asked to complete the training and complete food diaries every day for
      four weeks. The successful/ unsuccessful attempts at implementation intentions will be
      assessed weekly by a mentor. A researcher/clinician will discuss setting the implementation
      intention goals with the participant over email. At the end of the training, participants
      will enter the lab to re-complete the four tasks while researchers record brain activation
      using the EEG. They will also be asked to complete the food rating task again and their
      weight will be re-assessed. Before leaving, they will be asked to complete a feedback sheet
      in which they can express their experience with the training, in terms of facilitators and
      barriers and visual analogue scales that will ask participants to rate the acceptability,
      usefulness and level of burden experienced with training.

      Participants will then be followed up at 1 month post-intervention; they will be asked to
      complete the battery of questionnaires used at baseline and post-intervention.
    

Intervention name(s): Food specific Inhibitory control training; Implementation intentions; General inhibitory control training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): It involves a go/no-go task in which participants are requested to respond by clicking a particular button when a specific stimulus appears and requested to withhold their response when another particular stimulus appears. Stimuli in this intervention include photos of food and non-food.; It involves designing "if-then" strategies of behaviour. Participants will be asked to describe situations in which they feel they are more prone to behave in a way that is not congruent to their long term goals, and then to plan strategies to behave differently when faced with this situation in the future.; It involves a go/no-go task in which participants are requested to respond by clicking a particular button when a specific stimulus appears and requested to withhold their response when another particular stimulus appears. Stimuli in this intervention include only non-food pictures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The model includes two interventions (i.e. inhibitory control training and implementation intentions) that aim to target cognitive processes that have been reported to play a role in the onset and maintenance of eating disorders. Moreover, three arms exist, one for healthy controls including only one EEG assessment, and two interventional arms for participants with eating disorders. Participants in one interventional arm will receive food-specific inhibitory control training, while participants in the other interventional arm will receive general inhibitory control training. These are delivered through a website task (go/no-go training),
Masking: None (Open Label)
Primary purpose: Treatment