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A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders. (ET4AN)

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gradual exposure to food stimuli
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

19 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria

  • Female
  • Proficiency in English
  • Right-handed
  • Between 19 and 60 years.
  • Diagnosis of Anorexia Nervosa for participants in the clinical group.
  • Body Mass Index between 18.5 and 25 kg/m² and no history of, or current, mood and anxiety disorders for participants in the healthy control group.

Exclusion criteria

  • History of head trauma
  • Hearing or visual impairment
  • Neurological disease
  • Claustrophobia
  • Pregnancy
  • Metal in the body which cannot be removed
  • History of (or current) drugs and/or alcohol abuse
  • Acute suicidality
  • Psychotropic medication (other than antidepressants in the patient group).

Sites / Locations

  • Valentina Cardi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gradual exposure to food stimuli

Arm Description

The intervention entails 2 sessions of psychoeducation and a clinical assessment including a discussion on learned food-related fears, role of food-related fears in the maintenance of anorexia nervosa, anxiety and its time course, avoidance, exposure and habituation, irrational fears and safety behaviors; and 8 sessions of in vivo exposure to foods, starting from the least scary food of a hierarchy of threatening foods created by each patient. Each session will involve exposure to a new food item and patients will be encouraged to confront their fear by looking at and touching the chosen food item. They will also be encouraged to eat the food and reflect on the consequences of eating and assessing those relative to their fears (e.g. checking whether they have lost control or changed shape after eating).

Outcomes

Primary Outcome Measures

Body mass index (body weight in kilograms divided by height in meters squared).
Patients' weight and height are recorded.
Eating Disorder Examination Questionnaire (TOTAL subscale).
Total score derived from 36 items. The items are rated using a Likert scale ranging from 0 to 6.
Visual analogue scale measuring anxiety symptoms. Participants are asked to answer the question "How anxious do you feel in this moment?" in response to viewing food pictures during a brain scan.
Visual analogue scale ranging from 0 (not anxious at all) to 100 (extremely anxious).

Secondary Outcome Measures

Likert scale measuring participants' confidence to challenge their eating disorder.
Likert scale ranging from 0 (not confident at all) to 10 (very confident).

Full Information

First Posted
September 14, 2015
Last Updated
September 15, 2015
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT02551445
Brief Title
A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders.
Acronym
ET4AN
Official Title
A fMRI Pilot Study of the Effects of Cognitive Behavioural Therapy (Meal-support) in Eating Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study involves people with eating disorders and healthy volunteers (people who have never experienced an eating disorder). Participants are interviewed about their psychological and physical health by the experimenter and they have a simulated scan session (about 1 hour). Approximately 1 week after they attend the first study session. They are asked to complete questionnaires and computerized tasks (about 30 minutes) followed by the active scan (1 hour). During the brain scan they look at pictures and answer questions about the pictures. After the first study session, people with eating disorders receive an intensive meal-support intervention (in the following 3 months) aimed at reducing anxiety and fears related to food (10 sessions lasting about 60 min.). Three months after the first brain scan, participants with eating disorders and healthy controls receive a second assessment and brain scan. We hypothesized that the meal support intervention will be effective in: 1) targeting eating disorder symptoms (body mass index - BMI, primarily) and 2) producing functional changes in brain regions that underline food-related anxiety and avoidance.
Detailed Description
Anorexia nervosa (AN) is characterized by severe malnutrition. Patients report aversive experiences of re-feeding and frequently drop-out from treatment. This study will test the hypothesis that gradual and guided exposure to food is associated with increased body mass index (BMI) and reduced eating disorder psychopathology in patients with AN. It is also hypothesized that the intervention will lead to changes in brain activation in regions implicated in anticipatory anxiety and fear of food and emotion regulation (i.e. amygdala, insula, dorso-lateral prefrontal cortex [DLPFC]). Sixteen women with anorexia nervosa not receiving any interventions at the time of the study will be recruited from the community. Patients will complete a range of self-report measures and will undergo a functional magnetic resonance imaging (fMRI) scan before and after receiving 10 exposure therapy sessions over 3 months. A matched healthy control group (n=20) will also have two brain scans 3 months apart. To be eligible for the study, participants will have to be female, proficient in English, right-handed, between 19 and 60 years. Participants in the clinical group will have to meet the DSM-IV-TR diagnostic criteria for anorexia nervosa. Participants in the healthy control group will be required to have a BMI between 18.5 and 25 kg/m² and no history of, or current, mood and anxiety disorders. Additional exclusion criteria will be: history of head trauma, hearing or visual impairment, neurological disease, claustrophobia, pregnancy, metal in the body which cannot be removed, history of (or current) drugs and/or alcohol abuse; acute suicidality, psychotropic medication (other than antidepressants in the patient group). Pre- and post-intervention changes in patients' BMI, anxiety, eating disorders symptoms, mood and motivation to change will be assessed. Changes in brain activations in selected regions of interest, including the DLPFC, amygdala and insula will be examined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gradual exposure to food stimuli
Arm Type
Experimental
Arm Description
The intervention entails 2 sessions of psychoeducation and a clinical assessment including a discussion on learned food-related fears, role of food-related fears in the maintenance of anorexia nervosa, anxiety and its time course, avoidance, exposure and habituation, irrational fears and safety behaviors; and 8 sessions of in vivo exposure to foods, starting from the least scary food of a hierarchy of threatening foods created by each patient. Each session will involve exposure to a new food item and patients will be encouraged to confront their fear by looking at and touching the chosen food item. They will also be encouraged to eat the food and reflect on the consequences of eating and assessing those relative to their fears (e.g. checking whether they have lost control or changed shape after eating).
Intervention Type
Behavioral
Intervention Name(s)
Gradual exposure to food stimuli
Intervention Description
Patients with anorexia nervosa will be encouraged to confront their fears and avoidance in relation to food and will be gradually exposed to different food items during the sessions.
Primary Outcome Measure Information:
Title
Body mass index (body weight in kilograms divided by height in meters squared).
Description
Patients' weight and height are recorded.
Time Frame
Approximately 3 months after the completion of the baseline questionnaires.
Title
Eating Disorder Examination Questionnaire (TOTAL subscale).
Description
Total score derived from 36 items. The items are rated using a Likert scale ranging from 0 to 6.
Time Frame
Approximately 3 months after the completion of the baseline questionnaires.
Title
Visual analogue scale measuring anxiety symptoms. Participants are asked to answer the question "How anxious do you feel in this moment?" in response to viewing food pictures during a brain scan.
Description
Visual analogue scale ranging from 0 (not anxious at all) to 100 (extremely anxious).
Time Frame
Approximately 3 months after the completion of the baseline questionnaires.
Secondary Outcome Measure Information:
Title
Likert scale measuring participants' confidence to challenge their eating disorder.
Description
Likert scale ranging from 0 (not confident at all) to 10 (very confident).
Time Frame
Approximately 3 months after the completion of the baseline questionnaires.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria Female Proficiency in English Right-handed Between 19 and 60 years. Diagnosis of Anorexia Nervosa for participants in the clinical group. Body Mass Index between 18.5 and 25 kg/m² and no history of, or current, mood and anxiety disorders for participants in the healthy control group. Exclusion criteria History of head trauma Hearing or visual impairment Neurological disease Claustrophobia Pregnancy Metal in the body which cannot be removed History of (or current) drugs and/or alcohol abuse Acute suicidality Psychotropic medication (other than antidepressants in the patient group).
Facility Information:
Facility Name
Valentina Cardi
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders.

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