Back to resultsRCT Comparing EMDR and CBT for Treatment of Resistant Depression
Primary Purpose
Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy, Neurobiological Processing
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EMDR
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Eye Movement Desensitization and Reprocessing focused on measuring depression, neurobiology of emotions, Cognitive Behavioral Therapy, Eye Movement Desensitization and Reprocessing, trauma, psychotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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);
- 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
Sites / Locations
- AOU Città della Salute e della Scienza di TorinoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eye Movement Desensitization and Reprocessing
Cognitive Behavioral Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in depressive symptoms
Beck Depression Inventory II (BDI-II)
changes in depressive symptoms
Hamilton Depression Rating Scale (HDRS)
changes in cognitive component of depressive syndrome
Beck Hopelessness Scale (BHS)
changes in HD-EEG
HD-EEG in resting state phase and a second phase with a task
changes in fMRI
fMRI in resting state phase and a second phase with a task
changes in HRV
HRV detection during hdEEG assessment
psychiatric diagnosis
Structured Clinical Interview for DSM-5 (SCID-5)
changing in depressive symptoms
Patient Health Questionnaire-9 (PHQ-9)
Secondary Outcome Measures
addressing potentially traumatizing events
Traumatic Experience Checklist (TEC)
assessing childhood trauma
Childhood Trauma Questionnaire (CTQ)
evaluating the quality of relationships
Relationship Questionnaire (RQ)
changing in dissociative symptoms
Brief Dissociative Experiences Scale (DES-B)
changing in autonomic symptoms
Composite Autonomic Symptom Score (COMPASS-31)
changing in the emotional regulation
Difficulties in Emotion Regulation Scale (DERS)
changing in the dimensions of the emotional style
Emotional Style Questionnaire (ESQ)
changing in quality of sleep, in particular insomnia
Insomnia Severity Index (ISI)
changing in physical activity habits
International Physical Activity Questionnaire Short Form (IPAQ-SF)
changing in post-traumatic symptoms
International Trauma Questionnaire
changing in suicidal thinking
Paykel Suicide Scale
changing in stress
Perceived Stress Scale (PSS)
changing in post-traumatic stress symptoms
PTSD Checklist for DSM-5 (PCL-5)
assessing disability and functional impairment as a result of treatment
Sheehan Disability Scale for Treatment Induced Impairment (SDS-T)
changing in anxiety symptoms
General Anxiety Disorder-7 (GAD-7)
Full Information
NCT ID
NCT03972033
First Posted
March 27, 2019
Last Updated
March 9, 2022
Sponsor
University of Turin, Italy
Collaborators
EMDR Europe
1. Study Identification
Unique Protocol Identification Number
NCT03972033
Brief Title
RCT Comparing EMDR and CBT for Treatment of Resistant Depression
Official Title
Multicenter RCT Comparing EMDR and CBT Efficacy for Treatmen of Resistant Depression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
Collaborators
EMDR Europe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy, Neurobiological Processing, Depression, Functional Magnetic Resonance Imaging, High Definition Electroencefalography, Heart Rate Variability
Keywords
depression, neurobiology of emotions, Cognitive Behavioral Therapy, Eye Movement Desensitization and Reprocessing, trauma, psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The design of the study is a randomized controlled clinical trial.
Masking
Outcomes Assessor
Masking Description
Outcomes assessors doesn't know the patient group assignment.
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eye Movement Desensitization and Reprocessing
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Other Intervention Name(s)
Eye Movement Desensitization and Reprocessing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in depressive symptoms
Description
Beck Depression Inventory II (BDI-II)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).
Title
changes in depressive symptoms
Description
Hamilton Depression Rating Scale (HDRS)
Time Frame
week 0, week 16, week 40
Title
changes in cognitive component of depressive syndrome
Description
Beck Hopelessness Scale (BHS)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changes in HD-EEG
Description
HD-EEG in resting state phase and a second phase with a task
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changes in fMRI
Description
fMRI in resting state phase and a second phase with a task
Time Frame
month 0 (T0)
Title
changes in HRV
Description
HRV detection during hdEEG assessment
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
psychiatric diagnosis
Description
Structured Clinical Interview for DSM-5 (SCID-5)
Time Frame
month 0 (T0)
Title
changing in depressive symptoms
Description
Patient Health Questionnaire-9 (PHQ-9)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Secondary Outcome Measure Information:
Title
addressing potentially traumatizing events
Description
Traumatic Experience Checklist (TEC)
Time Frame
month 0 (T0)
Title
assessing childhood trauma
Description
Childhood Trauma Questionnaire (CTQ)
Time Frame
month 0 (T0)
Title
evaluating the quality of relationships
Description
Relationship Questionnaire (RQ)
Time Frame
month 0 (T0)
Title
changing in dissociative symptoms
Description
Brief Dissociative Experiences Scale (DES-B)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in autonomic symptoms
Description
Composite Autonomic Symptom Score (COMPASS-31)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in the emotional regulation
Description
Difficulties in Emotion Regulation Scale (DERS)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in the dimensions of the emotional style
Description
Emotional Style Questionnaire (ESQ)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in quality of sleep, in particular insomnia
Description
Insomnia Severity Index (ISI)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in physical activity habits
Description
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in post-traumatic symptoms
Description
International Trauma Questionnaire
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in suicidal thinking
Description
Paykel Suicide Scale
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in stress
Description
Perceived Stress Scale (PSS)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
changing in post-traumatic stress symptoms
Description
PTSD Checklist for DSM-5 (PCL-5)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Title
assessing disability and functional impairment as a result of treatment
Description
Sheehan Disability Scale for Treatment Induced Impairment (SDS-T)
Time Frame
1 month time frame
Title
changing in anxiety symptoms
Description
General Anxiety Disorder-7 (GAD-7)
Time Frame
month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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);
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Ostacoli, Associate Professor
Phone
3335613155
Email
luca.ostacoli@unito.it
Facility Information:
Facility Name
AOU Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Ostacoli, Assistant Professor
Phone
3335613155
Email
luca.ostacoli@unito.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
RCT Comparing EMDR and CBT for Treatment of Resistant Depression
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