An interventional study of EMDR and CBT in Eye Movement Desensitization and Reprocessing, Cognitive Behavioral Therapy and Neurobiological Processing, sponsored by University of Turin, Italy. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by University of Turin, Italy · Not applicable, Interventional, and Treatment
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.
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.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 128 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University of Turin, Italy is the lead sponsor of 213 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: EMDR
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.
Behavioral: CBT
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.
Also known as: 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.
Also known as: Cognitive Behavioral Therapy
Changes in depressive symptoms
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).
changes in depressive symptoms
Hamilton Depression Rating Scale (HDRS)
Time frame: week 0, week 16, week 40
changes in cognitive component of depressive syndrome
Beck Hopelessness Scale (BHS)
Time frame: 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
Time frame: 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
Time frame: month 0 (T0)
changes in HRV
HRV detection during hdEEG assessment
Time frame: 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)
Time frame: month 0 (T0)
changing in depressive symptoms
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
addressing potentially traumatizing events
Traumatic Experience Checklist (TEC)
Time frame: month 0 (T0)
assessing childhood trauma
Childhood Trauma Questionnaire (CTQ)
Time frame: month 0 (T0)
evaluating the quality of relationships
Relationship Questionnaire (RQ)
Time frame: month 0 (T0)
changing in dissociative symptoms
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)
changing in autonomic symptoms
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)
changing in the emotional regulation
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)
changing in the dimensions of the emotional style
Emotional Style Questionnaire (ESQ)
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
Insomnia Severity Index (ISI)
Time frame: 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)
Time frame: 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
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in suicidal thinking
Paykel Suicide Scale
Time frame: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
changing in stress
Perceived Stress Scale (PSS)
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
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)
assessing disability and functional impairment as a result of treatment
Sheehan Disability Scale for Treatment Induced Impairment (SDS-T)
Time frame: 1 month time frame
changing in anxiety symptoms
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
Plan to share: Undecided
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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