Comparing EMDR with CBT for the treatment of anorexia nervosa
| ISRCTN | ISRCTN16211499 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16211499 |
| Secondary identifying numbers | 0000306 |
- Submission date
- 13/10/2019
- Registration date
- 22/10/2019
- Last edited
- 14/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 December 2024
Who is funding the study?
Italian EMDR Association (Italy)
Who is the main contact?
Dr Sara Bertelli, sara.bertelli@asst-santipaolocarlo.it
Contact information
Scientific
U.O. di Psichiatria Presidio San Paolo
via Antonio di Rudinì 8
Milan
20142
Italy
| Phone | +39 0239043518 |
|---|---|
| sara.bertelli@asst-santipaolocarlo.it |
Study information
| Study design | Single-center interventional randomized longitudinal trial study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Eye Movement Desensitization and Reprocessing (EMDR) versus Cognitive-Behavioral Therapy (CBT) in the treatment of anorexia nervosa: a randomized clinical trial |
| Study acronym | EMDR-DCA |
| Study objectives | This study aims to investigate the differences in clinical and neurophysiological outcome in anorexia nervosa after treatment with CBT or EMDR therapy |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2017 |
| Completion date | 15/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 25 Years |
| Sex | Female |
| Target number of participants | 50 |
| Total final enrolment | 53 |
| Key inclusion criteria | 1. Females aged 15-25 years 2. Newly diagnosed with anorexia nervosa using DSM-V criteria |
| Key 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 |
| Date of first enrolment | 14/03/2018 |
| Date of final enrolment | 15/05/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milano
20142
Italy
Sponsor information
Hospital/treatment centre
Ospedale San Paolo U.O. Psichiatria 52
Via A. di Rudinì, 8
Milan
20142
Italy
| Phone | +39 0281844732 |
|---|---|
| ambulatorio.dca.hsp@asst-santipaolocarlo.it | |
| Website | http://www.asst-santipaolocarlo.it/ |
"ROR" |
https://ror.org/0026m8b31 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
14/02/2025: Total final enrolment added.
28/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/09/2023 to 15/05/2024.
2. The overall end date was changed from 14/03/2024 to 15/12/2024.
3. The intention to publish date was changed from 14/03/2024 to 15/09/2025.
4. The plain English summary was updated to reflect these changes.
23/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/03/2023 to 14/09/2023.
2. The overall end date was changed from 14/09/2023 to 14/03/2024.
3. The intention to publish date was changed from 14/09/2023 to 14/03/2024.
4. The plain English summary was updated to reflect these changes.
16/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/09/2021 to 14/03/2023.
2. The overall trial end date was changed from 14/03/2022 to 14/09/2023.
17/11/2021: Recruitment for this study is no longer paused as of September 2021.
16/11/2021: The trial participating centre has been changed from "U.O. Psichiatria - ASST Santi Paolo e Carlo - P.O. San Paolo" to "Department of Mental Health and Addiction, San Paolo University Hospital, ASST Santi Paolo e Carlo".
27/04/2020: Due to current public health guidance, recruitment for this study has been paused.
17/12/2019: The following changes have been made:
1. The recruitment end date has been changed from 14/09/2020 to 14/09/2021.
2. The overall trial end date has been changed from 14/03/2021 to 14/03/2022.
3. The intention to publish date has been changed from 14/09/2022 to 14/09/2023.
17/10/2019: Trial's existence confirmed by the Comitato Etico Milano Area 1 [Milan Area 1 Ethical Committee].
