Eye Movement Desensitization and ReprocessingNCT03972033
RCT Comparing EMDR and CBT for Treatment of Resistant Depression
A study testing EMDR and CBT in people with Eye Movement Desensitization and Reprocessing and Cognitive Behavioral Therapy, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Depression is one of the most common invalidating mental disorders, ranked by World Health Organization as the single largest contributor to global disability. Current recommended treatments for depression include antidepressant medication and according to guidelines, Cognitive Behavioral Therapy (CBT) and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy, Neurobiological Processing
- What is being tested?
- EMDR and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 31 Dec 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of Major Depressive Disorder, single episode or recurrent, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- a score of at least 20 on Beck's Depression Inventory-II (BDI-II);
- having received ADM treatment with a stable dose for at least six weeks and maintained stable during treatment;
- legal capacity to consent to the treatment.
Who cannot join
- diagnosis of current PTSD (assessed with MINI-Plus and the International Trauma Questionnaire - ITQ, Cloitre et al., 2018);
- diagnosis of complex PTSD (assessed with the ITQ);
- history of psychotic symptoms or schizophrenia;
- bipolar disorder or dementia;
- cluster A and B severe personality disorders;
- dissociative symptoms (DES-B score >2);
Show all 11Show fewer
- any substance-related abuse or dependence disorder (except those involving nicotine) in the 6 months prior to the study;
- a serious, unstable medical condition;
- a severely unstable social and economic condition (e.g. no fixed abode; job loss without any other source of income);
- being pregnant;
- acute suicidality that needs hospitalization
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, 10126
Luca Ostacoli, Assistant Professor, 3335613155, luca.ostacoli@unito.it
About this study
Official title: Multicenter RCT Comparing EMDR and CBT Efficacy for Treatmen of Resistant Depression
Depression is one of the most common invalidating mental disorders, ranked by World Health Organization as the single largest contributor to global disability. Current recommended treatments for depression include antidepressant medication and according to guidelines, Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT). Despite encouraging preliminary results (e.g., Matthijssen et al., 2020), Eye Movement Desensitization and Reprocessing (EMDR) therapy is not yet recognized as an effective therapy for depression by APA and NICE. The project aims to conduct a large multisite study that addresses the shortcomings of previous efficacy research on EMDR for depression. The primary aim is to evaluate the effectiveness of EMDR therapy in reducing depressive symptoms in adults with major depression as compared to CBT. Secondary aims of the study are the effectiveness of EMDR, as compared to CBT and TAU, in improving anxiety, and other symptoms. It is hypothesized that EMDR is not inferior to CBT.
Read the detailed description
The study is a multicenter clinical randomized controlled trial, conducted in Italy, USA and UK that will assess the effectiveness of EMDR therapy compared to CBT and TAU. Patients will be recruited at four clinical centers: Turin and Rome in Italy, and Kansas City in USA. The study protocol was approved by the local research ethics committee in each of the countries where the intervention is implemented.
- Conditions
- Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy, Neurobiological Processing, Depression, Functional Magnetic Resonance Imaging, High Definition Electroencefalography
- Being tested
- EMDR, CBT
- Keywords
- depression, neurobiology of emotions, Cognitive Behavioral Therapy, Eye Movement Desensitization and Reprocessing, trauma, psychotherapy
- Medical subject headings
- Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
Also called Eye Movement Desensitization and Reprocessing
Treatments will be independent and blinded to the clinical psychologists conducting the clinical assessments. EMDR and CBT treatments will be provided for 16 weeks, each comprising 16 weekly individual sessions. Interventions will be conducted according to published treatment manuals. All treatment sessions will be video recorded for fidelity rating and supervision.
As a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm.
CBTBehavioural
Also called Cognitive Behavioral Therapy
Treatments will be independent and blinded to the clinical psychologists conducting the clinical assessments. EMDR and CBT treatments will be provided for 16 weeks, each comprising 16 weekly individual sessions. Interventions will be conducted according to published treatment manuals. All treatment sessions will be video recorded for fidelity rating and supervision.
As a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Eye Movement Desensitization and Reprocessing | Experimental | The DeprEND manualized protocol (Hofmann, Ostacoli, et al., 2015) is based on the eight-phase protocol by Shapiro (2001) that was adapted for the treatment of depression by the European Depression EMDR Network and used in previous studies (Hase et al., 2015; Hofmann et al., 2014; Ostacoli et al., 2018). EMDR targets will be selected using the Adaptive Information Processing model that looks for stressful events linked with depression. The DeprEnd Fidelity Rating Scale will be used to assess treatment fidelity. The scale will be completed by trained EMDR therapists who will listen to the audio recordings of the sessions.
In each centre, EMDR is provided by psychotherapists specialized in Level II EMDR and with a minimum of three years of experience in treating patients with depression. They receive extensive training and supervision in the manualized protocol established for the study, from a certified senior EMDR instructor. Receives: Behavioral: EMDR |
| Cognitive Behavioral Therapy | Active comparator | Treatment protocol is based on the principles described by Beck (Beck et al., 1979) will be utilized. The treatment includes behavioral activation and cognitive restructuring with homework assignments. In each centre, CBT treatment is performed by psychotherapists with certified training in CBT techniques and a minimum of three years of experience in treating patients with depression. They receive regular CBT supervision to ensure that the quality of their CBT treatment was maintained. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms
Beck Depression Inventory II (BDI-II)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).
changes in depressive symptoms
Hamilton Depression Rating Scale (HDRS)
Measured: week 0, week 16, week 40
changes in cognitive component of depressive syndrome
Beck Hopelessness Scale (BHS)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changes in HD-EEG
HD-EEG in resting state phase and a second phase with a task
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changes in fMRI
fMRI in resting state phase and a second phase with a task
Measured: month 0 (T0)
changes in HRV
HRV detection during hdEEG assessment
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
psychiatric diagnosis
Structured Clinical Interview for DSM-5 (SCID-5)
Measured: month 0 (T0)
changing in depressive symptoms
Patient Health Questionnaire-9 (PHQ-9)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Secondary outcomes (15)
addressing potentially traumatizing events
Traumatic Experience Checklist (TEC)
Measured: month 0 (T0)
assessing childhood trauma
Childhood Trauma Questionnaire (CTQ)
Measured: month 0 (T0)
evaluating the quality of relationships
Relationship Questionnaire (RQ)
Measured: month 0 (T0)
changing in dissociative symptoms
Brief Dissociative Experiences Scale (DES-B)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in autonomic symptoms
Composite Autonomic Symptom Score (COMPASS-31)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in the emotional regulation
Difficulties in Emotion Regulation Scale (DERS)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in the dimensions of the emotional style
Emotional Style Questionnaire (ESQ)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in quality of sleep, in particular insomnia
Insomnia Severity Index (ISI)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in physical activity habits
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in post-traumatic symptoms
International Trauma Questionnaire
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in suicidal thinking
Paykel Suicide Scale
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in stress
Perceived Stress Scale (PSS)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in post-traumatic stress symptoms
PTSD Checklist for DSM-5 (PCL-5)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
assessing disability and functional impairment as a result of treatment
Sheehan Disability Scale for Treatment Induced Impairment (SDS-T)
Measured: 1 month time frame
changing in anxiety symptoms
General Anxiety Disorder-7 (GAD-7)
Measured: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Movement Desensitization and ReprocessingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design of the study is a randomized controlled clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- EMDR Europe
- Responsible party
- Principal investigator, luca ostacoli, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972033
- Sponsor's protocol ID
- EMDRvsCBT
- Status last verified
- Mar 2022
- First submitted
- 27 Mar 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter RCT Comparing EMDR and CBT Efficacy for Treatmen of Resistant Depression
- ClinicalTrials.gov ID
- NCT03972033
- Acronym / sponsor ID
- EMDRvsCBT
- Conditions
- Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy, Neurobiological Processing, Depression, Functional Magnetic Resonance Imaging, High Definition Electroencefalography
- Keywords
- depression, neurobiology of emotions, Cognitive Behavioral Therapy, Eye Movement Desensitization and Reprocessing, trauma, psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- EMDR Europe
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jun 2019 (actual)
- 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.
Depression is one of the most common invalidating mental disorders, ranked by World Health Organization as the single largest contributor to global disability. Current recommended treatments for depression include antidepressant medication and according to guidelines, Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT). Despite encouraging preliminary results (e.g., Matthijssen et al., 2020), Eye Movement Desensitization and Reprocessing (EMDR) therapy is not yet recognized as an effective therapy for depression by APA and NICE. The project aims to conduct a large multisite study that addresses the shortcomings of previous efficacy research on EMDR for depression. The primary aim is to evaluate the effectiveness of EMDR therapy in reducing depressive symptoms in adults with major depression as compared to CBT. Secondary aims of the study are the effectiveness of EMDR, as compared to CBT and TAU, in improving anxiety, and other symptoms. It is hypothesized that EMDR is not inferior to CBT.
Detailed description
The study is a multicenter clinical randomized controlled trial, conducted in Italy, USA and UK that will assess the effectiveness of EMDR therapy compared to CBT and TAU. Patients will be recruited at four clinical centers: Turin and Rome in Italy, and Kansas City in USA. The study protocol was approved by the local research ethics committee in each of the countries where the intervention is implemented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design of the study is a randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing | Experimental | Behavioral: EMDRThe DeprEND manualized protocol (Hofmann, Ostacoli, et al., 2015) is based on the eight-phase protocol by Shapiro (2001) that was adapted for the treatment of depression by the European Depression EMDR Network and used in previous studies (Hase et al., 2015; Hofmann et al., 2014; Ostacoli et al., 2018). EMDR targets will be selected using the Adaptive Information Processing model that looks for stressful events linked with depression. The DeprEnd Fidelity Rating Scale will be used to assess treatment fidelity. The scale will be completed by trained EMDR therapists who will listen to the audio recordings of the sessions. In each centre, EMDR is provided by psychotherapists specialized in Level II EMDR and with a minimum of three years of experience in treating patients with depression. They receive extensive training and supervision in the manualized protocol established for the study, from a certified senior EMDR instructor. |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: CBTTreatment protocol is based on the principles described by Beck (Beck et al., 1979) will be utilized. The treatment includes behavioral activation and cognitive restructuring with homework assignments. In each centre, CBT treatment is performed by psychotherapists with certified training in CBT techniques and a minimum of three years of experience in treating patients with depression. They receive regular CBT supervision to ensure that the quality of their CBT treatment was maintained. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of Major Depressive Disorder, single episode or recurrent, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- a score of at least 20 on Beck's Depression Inventory-II (BDI-II);
- having received ADM treatment with a stable dose for at least six weeks and maintained stable during treatment;
- legal capacity to consent to the treatment.
Key exclusion criteria (11 listed)
- diagnosis of current PTSD (assessed with MINI-Plus and the International Trauma Questionnaire - ITQ, Cloitre et al., 2018);
- diagnosis of complex PTSD (assessed with the ITQ);
- history of psychotic symptoms or schizophrenia;
- bipolar disorder or dementia;
- cluster A and B severe personality disorders;
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 |
|---|---|---|
| EMDRAlso: Eye Movement Desensitization and ReprocessingTreatments will be independent and blinded to the clinical psychologists conducting the clinical assessments. EMDR and CBT treatments will be provided for 16 weeks, each comprising 16 weekly individual sessions. Interventions will be conducted according to published treatment manuals. All treatment sessions will be video recorded for fidelity rating and supervision. As a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm. | Behavioural | Eye Movement Desensitization and Reprocessing |
| CBTAlso: Cognitive Behavioral TherapyTreatments will be independent and blinded to the clinical psychologists conducting the clinical assessments. EMDR and CBT treatments will be provided for 16 weeks, each comprising 16 weekly individual sessions. Interventions will be conducted according to published treatment manuals. All treatment sessions will be video recorded for fidelity rating and supervision. As a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Changes in depressive symptoms
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).
Beck Depression Inventory II (BDI-II)
changes in depressive symptoms
Time frame: week 0, week 16, week 40
Hamilton Depression Rating Scale (HDRS)
changes in cognitive component of depressive syndrome
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Beck Hopelessness Scale (BHS)
changes in HD-EEG
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
HD-EEG in resting state phase and a second phase with a task
changes in fMRI
Time frame: month 0 (T0)
fMRI in resting state phase and a second phase with a task
changes in HRV
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
HRV detection during hdEEG assessment
psychiatric diagnosis
Time frame: month 0 (T0)
Structured Clinical Interview for DSM-5 (SCID-5)
changing in depressive symptoms
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Patient Health Questionnaire-9 (PHQ-9)
15 secondary outcomes
addressing potentially traumatizing events
Time frame: month 0 (T0)
assessing childhood trauma
Time frame: month 0 (T0)
evaluating the quality of relationships
Time frame: month 0 (T0)
changing in dissociative symptoms
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in autonomic symptoms
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in the emotional regulation
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in the dimensions of the emotional style
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in quality of sleep, in particular insomnia
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in physical activity habits
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in post-traumatic symptoms
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in suicidal thinking
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in stress
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in post-traumatic stress symptoms
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
assessing disability and functional impairment as a result of treatment
Time frame: 1 month time frame
changing in anxiety symptoms
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR and CBT in people with Eye Movement Desensitization and Reprocessing and Cognitive Behavioral Therapy, run by University of Turin, Italy at 1 site in Italy.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Ostacoli, Associate Professor (3335613155, luca.ostacoli@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depressive symptoms (time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).). The study lists 8 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 14 Mar 2022.