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

NCT02551445 | Completed

• 1 other identifier: PIEF-2011-299232
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (3)

• Body mass index (body weight in kilograms divided by height in meters squared).

  Patients' weight and height are recorded.

  Approximately 3 months after the completion of the baseline questionnaires.

• 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.

  Approximately 3 months after the completion of the baseline questionnaires.

• 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).

  Approximately 3 months after the completion of the baseline questionnaires.

Secondary Outcomes (1)

• Likert scale measuring participants' confidence to challenge their eating disorder.

  Approximately 3 months after the completion of the baseline questionnaires.

Study Arms (1)

Gradual exposure to food stimuli

EXPERIMENTAL

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).

Behavioral: Gradual exposure to food stimuli

Interventions

Gradual exposure to food stimuli BEHAVIORAL

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.

Gradual exposure to food stimuli

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Valentina Cardi

London, London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 16, 2015
• Study Start: September 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2014
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

GB (1)