Plain English Summary
Background and study aims
Anorexia nervosa (AN) is a severe mental disorder in which a person fears gaining weight or becoming fat, even though they might be very underweight. A person with AN may reduce their food intake, increase exercise and use laxatives or vomiting in order to control their weight and size. Some people with AN and other eating disorders have experienced trauma in their childhood and it is thought that the disorder may be a way of coping with negative emotions and experiences.
Eye movement desensitization and reprocessing (EMDR) is a type of talking therapy in which a person recalls memories of traumatic events and is guided by the therapist to move their eyes or hands in a certain way. This is thought to help the mind process the experience and make it less troubling. EMDR has been used in people with post-traumatic stress disorder (PTSD), but little is known about whether it might help people with AN.
This study aims to compare EMDR with cognitive behavioural therapy (CBT, another widely used talking therapy) in people with AN.
Who can participate?
Girls and women aged 15-25 years with AN
What does the study involve?
The participants will be randomly allocated to receive 16 sessions of EMDR or CBT. They will be followed up after the last treatment session and 6 months after that.
What are the possible benefits and risks of participating?
There are no potential risks envisaged other than the possibility of a worsening of the participants’ condition. Any health conditions or side effects will be managed according to the best clinical practice in the center. Participants will be evaluated on a case–by–case basis by the researchers to decide whether they should continue participating in the study.
Where is the study run from?
Presidio San Paolo Psychiatric Hospital (Italy)
When is the study starting and how long is it expected to run for?
May 2017 to March 2021
Who is funding the study?
Italian EMDR Association (Italy)
Who is the main contact?
Dr Sara Bertelli, sara.bertelli@asst-santipaolocarlo.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sara Bertelli
ORCID ID
Contact details
U.O. di Psichiatria Presidio San Paolo
via Antonio di Rudinì 8
Milan
20142
Italy
+39 0239043518
sara.bertelli@asst-santipaolocarlo.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
0000306
Study information
Scientific title
Eye Movement Desensitization and Reprocessing (EMDR) versus Cognitive-Behavioral Therapy (CBT) in the treatment of anorexia nervosa: a randomized clinical trial
Acronym
EMDR-DCA
Study hypothesis
This study aims to investigate the differences in clinical and neurophysiological outcome in anorexia nervosa after treatment with CBT or EMDR therapy
Ethics approval
Approved 14/03/2018, Comitato Etico Milano Area 1, ASST Santi Paolo e Carlo (74 via GB Grassi, 20157 Milan, Italy; +39 02 8184 4118; comitatoetico.hsp@asst-santipaolocarlo.it), ref: 0000306
Study design
Single-center interventional randomized longitudinal trial study. study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Anorexia nervosa
Intervention
Participants will receive 16 Cognitive-Behavioral Therapy (CBT) or Eye Movement Desensitization and Reprocessing (EMDR) sessions with a licensed psychotherapist in a block-randomized order. First follow-up (T1) will be at the end of 16 sessions and second follow-up (T2) 6 months after the last session.
Adverse events (AEs) are highly underreported in psycholological RCTs. In line with recent recommendations, the investigators will report the proportion of patients who deteriorate on clinical measures in both the experimental and control groups. They will explain how AEs were defined and recorded and will try to identify AEs that are plausibly related to the intervention
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Eating disorder severity measured using the global score of the Eating Disorder Examination (EDE) questionnaire from T0 (baseline) to T1 (after 16 therapy sessions)
Secondary outcome measures
1. Eating Disorder Severity measured using the global score of the Eating Disorder Examination (EDE) questionnaire from T1 (after 16 therapy sessions) to T2 (6 months after the last session)
2. Emotional regulation ability assessed using the Difficulties in Emotion Regulation Scale (DERS) at baseline, T1 and T2
3. Psychosocial impairment severity assessed using the Clinical Impairment Assessment (CIA) questionnaire at baseline, T1 and T2
4. Attitudes towards the body assessed using the Body Attitudes Test (BAT) at baseline, T1 and T2
5. Dissociative symptoms assessed using the Dissociative Experiences Scale (DES) at baseline, T1 and T2
6. Attachment assessed using the Adult Attachment Interview (AAI) at baseline, T1 and T2
7. Body mass index (BMI) assessed by measuring weight and height at baseline, T1 and T2
8. Brain activity measured using high-density electroencephalography (EEG) using 64 scalp electrodes during the AAI at baseline and T1
Overall trial start date
01/05/2017
Overall trial end date
14/03/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Females aged 15-25 years
2. Newly diagnosed with anorexia nervosa using DSM-V criteria
Participant type
Patient
Age group
Mixed
Gender
Female
Target number of participants
50
Participant exclusion criteria
1. Inability to speak or read Italian language
2. Any general medical condition interfering with eating habits, including metabolic disorders
3. Perinatal trauma or severe neurological disorder
4. Any severe psychiatric comorbidity (excluding personality disorders)
5. Psychotherapy of any kind in the previous year
6. EMDR or CBT psychotherapy in the medical history
Recruitment start date
14/03/2018
Recruitment end date
14/09/2020
Locations
Countries of recruitment
Italy
Trial participating centre
U.O. Psichiatria - ASST Santi Paolo e Carlo - P.O. San Paolo
via Antonio di Rudinì 8,
Milano
20142
Italy
Sponsor information
Organisation
ASST Santi Paolo e Carlo
Sponsor details
Ospedale San Paolo U.O. Psichiatria 52
Via A. di Rudinì
8
Milan
20142
Italy
+39 0281844732
ambulatorio.dca.hsp@asst-santipaolocarlo.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Associazione per I'EMDR in Italia [Italian EMDR Association]
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication will include results on clinical outcome and EEG coherence before and after treatment. Dissemination of the trial also will include presentations and talks in international conferences.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
14/09/2022
Participant level data
Other
Basic results (scientific)
Publication list