- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551445
A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders. (ET4AN)
A fMRI Pilot Study of the Effects of Cognitive Behavioural Therapy (Meal-support) in Eating Disorders.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, SE5 8AF
- Valentina Cardi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Gradual exposure to food stimuli
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index (body weight in kilograms divided by height in meters squared).
Time Frame: Approximately 3 months after the completion of the baseline questionnaires.
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Patients' weight and height are recorded.
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Approximately 3 months after the completion of the baseline questionnaires.
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Eating Disorder Examination Questionnaire (TOTAL subscale).
Time Frame: Approximately 3 months after the completion of the baseline questionnaires.
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Total score derived from 36 items.
The items are rated using a Likert scale ranging from 0 to 6.
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Approximately 3 months after the completion of the baseline questionnaires.
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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.
Time Frame: Approximately 3 months after the completion of the baseline questionnaires.
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Visual analogue scale ranging from 0 (not anxious at all) to 100 (extremely anxious).
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Approximately 3 months after the completion of the baseline questionnaires.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Likert scale measuring participants' confidence to challenge their eating disorder.
Time Frame: Approximately 3 months after the completion of the baseline questionnaires.
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Likert scale ranging from 0 (not confident at all) to 10 (very confident).
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Approximately 3 months after the completion of the baseline questionnaires.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIEF-2011-299232
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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