Cognitive Behavioral Therapy, Depression, Eye Movement Desensitization and Reprocessing, Functional Magnetic Resonance Imaging, Heart Rate Variability, High Definition Electroencefalography, Neurobiological Processing
Conditions
Keywords
depression, neurobiology of emotions, Cognitive Behavioral Therapy, Eye Movement Desensitization and Reprocessing, trauma, psychotherapy
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.
Interventions
BEHAVIORALEMDR
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 As a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm.
BEHAVIORALCBT
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.
Sponsors
EMDR Europe
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors doesn't know the patient group assignment.
Intervention model description
The design of the study is a randomized controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. a diagnosis of Major Depressive Disorder, single episode or recurrent, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 2. a score of at least 20 on Beck's Depression Inventory-II (BDI-II); 3. having received ADM treatment with a stable dose for at least six weeks and maintained stable during treatment; 4. legal capacity to consent to the treatment.
Exclusion criteria
1. diagnosis of current PTSD (assessed with MINI-Plus and the International Trauma Questionnaire - ITQ, Cloitre et al., 2018); 2. diagnosis of complex PTSD (assessed with the ITQ); 3. history of psychotic symptoms or schizophrenia; 4. bipolar disorder or dementia; 5. cluster A and B severe personality disorders; 6. dissociative symptoms (DES-B score \>2); 7. any substance-related abuse or dependence disorder (except those involving nicotine) in the 6 months prior to the study; 8. a serious, unstable medical condition; 9. a severely unstable social and economic condition (e.g. no fixed abode; job loss without any other source of income); 10. being pregnant; 11. acute suicidality that needs hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in depressive symptoms | 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 | week 0, week 16, week 40 | Hamilton Depression Rating Scale (HDRS) |
| changes in cognitive component of depressive syndrome | 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 | 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 | month 0 (T0) | fMRI in resting state phase and a second phase with a task |
| changes in HRV | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | HRV detection during hdEEG assessment |
| psychiatric diagnosis | month 0 (T0) | Structured Clinical Interview for DSM-5 (SCID-5) |
| changing in depressive symptoms | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changing in physical activity habits | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | International Physical Activity Questionnaire Short Form (IPAQ-SF) |
| changing in post-traumatic symptoms | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | International Trauma Questionnaire |
| changing in suicidal thinking | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | Paykel Suicide Scale |
| addressing potentially traumatizing events | month 0 (T0) | Traumatic Experience Checklist (TEC) |
| changing in post-traumatic stress symptoms | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | PTSD Checklist for DSM-5 (PCL-5) |
| assessing disability and functional impairment as a result of treatment | 1 month time frame | Sheehan Disability Scale for Treatment Induced Impairment (SDS-T) |
| changing in anxiety symptoms | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week | General Anxiety Disorder-7 (GAD-7) |
| changing in stress | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | Perceived Stress Scale (PSS) |
| assessing childhood trauma | month 0 (T0) | Childhood Trauma Questionnaire (CTQ) |
| evaluating the quality of relationships | month 0 (T0) | Relationship Questionnaire (RQ) |
| changing in dissociative symptoms | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | Brief Dissociative Experiences Scale (DES-B) |
| changing in autonomic symptoms | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | Composite Autonomic Symptom Score (COMPASS-31) |
| changing in the emotional regulation | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | Difficulties in Emotion Regulation Scale (DERS) |
| changing in the dimensions of the emotional style | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | Emotional Style Questionnaire (ESQ) |
| changing in quality of sleep, in particular insomnia | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | Insomnia Severity Index (ISI) |
Countries
Italy
Contacts
Primary ContactLuca Ostacoli, Associate Professor
Outcome results
None listed