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A Multimodal Outcome Study of Eating Disorders

22 oktober 2019 uppdaterad av: King's College London

Targeting Top-down and Bottom-up Processing in Eating Disorders Using Computerized Training Approaches: A Multimodal Outcome Study

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • London, Storbritannien, SE5 8AF
        • Eating Disorders Unit, Institute of Psychiatry, Psychology, and Neuroscience

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

1) Diagnosis of an Eating Disorder (Bulimia Nervosa or Binge Eating Disorder); 2) No severe psychiatric comorbidity (e.g. psychosis); 3) Fluency in English; 4) No visual impairment; 5) No cognitive/neurological impairment; 6) No drugs or alcohol abuse; 7) No use of weight-loss medication; 8 No metabolic disorder; 9) Above 18 years old and below 60 years old.

Exclusion Criteria:

1) No diagnosis of an eating disorder; 2) Severe psychiatric comorbidity; 3) No English language fluency; 4) Visual impairment (not correctable with eye-wear); 5) Cognitive/neurological impairment; 6) Drug or alcohol abuse; 7) Use of weight-loss medication; 8) A metabolic disorder; 9) Below 18 years old and above 60 years old.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Food specific inhibitory control training
The stimuli in this task will involve pictures of food.
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.
Aktiv komparator: General inhibitory control training
The stimuli in this task will not involve pictures of food, but pictures of stationary and household items.
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.
Inget ingripande: Baseline brain activation assessment (healthy controls)
This arm is included to assess brain activation using EEG among healthy controls at baseline in order to compare responses to participants with eating disorders.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in eating disorder symptomatology
Tidsram: This will be assessed at baseline, intervention completion, and follow-up (1 month later)
Decrease in binge eating frequency and decrease in compensatory behaviours.
This will be assessed at baseline, intervention completion, and follow-up (1 month later)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in weight/BMI
Tidsram: This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
Weight will be measured by the researcher and BMI will be calculated.
This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
Change in inhibitory control
Tidsram: This will be assessed at baseline (Time 0) and intervention completion (4 weeks).
This will be assessed using the self-report measure of disinhibition and using the go/no-go computerized task.
This will be assessed at baseline (Time 0) and intervention completion (4 weeks).
Change in anxiety and depression symptoms
Tidsram: This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
This will be assessed using the GAD and PHQ measures.
This will be assessed at baseline (Time 0), intervention completion (4 weeks), and follow-up (8 weeks)
Changes in High Calorie Food Valuation
Tidsram: This will be assessed at baseline (Time 0) and post-intervention (4 weeks).
This will be assessed using the food rating task.
This will be assessed at baseline (Time 0) and post-intervention (4 weeks).
Changes in Low Calorie Food Valuation
Tidsram: This will be assessed at baseline (Time 0) and post-intervention (4 weeks).
This will be assessed using the food rating task.
This will be assessed at baseline (Time 0) and post-intervention (4 weeks).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Rayane Chami, MSc/ PhD Student, King's College London
  • Studierektor: Dr Valentina Cardi, PhD, King's College London
  • Studierektor: Professor Janet Treasure, King's College London
  • Studierektor: Dr Grainne McLoughlin, King's College London

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

26 november 2017

Primärt slutförande (Faktisk)

1 juni 2019

Avslutad studie (Faktisk)

1 juni 2019

Studieregistreringsdatum

Först inskickad

3 april 2017

Först inskickad som uppfyllde QC-kriterierna

19 april 2017

Första postat (Faktisk)

24 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 oktober 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 oktober 2019

Senast verifierad

1 oktober 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRAS Project ID: 209609

Plan för individuella deltagardata (IPD)

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Nej

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Kliniska prövningar på Friska

Kliniska prövningar på Food specific Inhibitory control training

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