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A Multimodal Outcome Study of Eating Disorders

22. oktober 2019 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Food specific inhibitory control training
The stimuli in this task will involve pictures of food.
Atferdsmessig: Food specific Inhibitory control training
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.
Atferdsmessig: Implementation intentions
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.
Atferdsmessig: Implementation intentions
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.
Atferdsmessig: General inhibitory control training
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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in eating disorder symptomatology
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in weight/BMI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

King's College London

Samarbeidspartnere

University of Exeter

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. november 2017

Primær fullføring (Faktiske)

1. juni 2019

Studiet fullført (Faktiske)

1. juni 2019

Datoer for studieregistrering

Først innsendt

3. april 2017

Først innsendt som oppfylte QC-kriteriene

19. april 2017

Først lagt ut (Faktiske)

24. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRAS Project ID: 209609

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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