Anorexia NervosaET4ANNCT02551445
A fMRI Pilot Study of the Effects of Meal-support in Eating Disorders.
A study testing Gradual exposure to food stimuli in people with Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Gradual exposure to food stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of head trauma
- Hearing or visual impairment
- Neurological disease
- Claustrophobia
- Pregnancy
- Metal in the body which cannot be removed
Show all 9Show fewer
- History of (or current) drugs and/or alcohol abuse
- Acute suicidality
- Psychotropic medication (other than antidepressants in the patient group).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A fMRI Pilot Study of the Effects of Cognitive Behavioural Therapy (Meal-support) in Eating Disorders.
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Gradual exposure to food stimuli
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual exposure to food stimuliBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Gradual exposure to food stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (body weight in kilograms divided by height in meters squared).
Patients' weight and height are recorded.
Measured: 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.
Measured: 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).
Measured: Approximately 3 months after the completion of the baseline questionnaires.
Secondary outcomes (1)
Likert scale measuring participants' confidence to challenge their eating disorder.
Likert scale ranging from 0 (not confident at all) to 10 (very confident).
Measured: Approximately 3 months after the completion of the baseline questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551445
- Sponsor's protocol ID
- PIEF-2011-299232
- Acronym
- ET4AN
- Status last verified
- Sep 2015
- First submitted
- 14 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A fMRI Pilot Study of the Effects of Cognitive Behavioural Therapy (Meal-support) in Eating Disorders.
- ClinicalTrials.gov ID
- NCT02551445
- Acronym / sponsor ID
- ET4AN / PIEF-2011-299232
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gradual exposure to food stimuli | Experimental | Behavioral: Gradual exposure to food stimuliThe 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). |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- Proficiency in English
- Right-handed
- Between 19 and 60 years.
- Diagnosis of Anorexia Nervosa for participants in the clinical group.
Key exclusion criteria (9 listed)
- History of head trauma
- Hearing or visual impairment
- Neurological disease
- Claustrophobia
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gradual exposure to food stimuliPatients 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. | Behavioural | Gradual exposure to food stimuli |
Primary outcome
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.
Patients' weight and height are recorded.
Eating Disorder Examination Questionnaire (TOTAL subscale).
Time frame: Approximately 3 months after the completion of the baseline questionnaires.
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.
Time frame: Approximately 3 months after the completion of the baseline questionnaires.
Visual analogue scale ranging from 0 (not anxious at all) to 100 (extremely anxious).
1 secondary outcome
Likert scale measuring participants' confidence to challenge their eating disorder.
Time frame: Approximately 3 months after the completion of the baseline questionnaires.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual exposure to food stimuli in people with Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2015.