Clinical trial NCT03972033: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: EMDR Europe
First posted: 2019-06-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design of the study is a randomized controlled clinical trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in depressive symptoms
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).
measure: changes in depressive symptoms
timeFrame: week 0, week 16, week 40
measure: changes in cognitive component of depressive syndrome
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changes in HD-EEG
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changes in fMRI
timeFrame: month 0 (T0)
measure: changes in HRV
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: psychiatric diagnosis
timeFrame: month 0 (T0)
measure: changing in depressive symptoms
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Secondary outcomes:
measure: addressing potentially traumatizing events
timeFrame: month 0 (T0)
measure: assessing childhood trauma
timeFrame: month 0 (T0)
measure: evaluating the quality of relationships
timeFrame: month 0 (T0)
measure: changing in dissociative symptoms
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in autonomic symptoms
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in the emotional regulation
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in the dimensions of the emotional style
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in quality of sleep, in particular insomnia
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in physical activity habits
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in post-traumatic symptoms
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in suicidal thinking
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in stress
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: changing in post-traumatic stress symptoms
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
measure: assessing disability and functional impairment as a result of treatment
timeFrame: 1 month time frame
measure: changing in anxiety symptoms
timeFrame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
References: