Depression Clinical Trial
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.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Città della Salute e della Scienza di Torino | Torino |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy | EMDR Europe |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in depressive symptoms | Beck Depression Inventory II (BDI-II) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup). | |
Primary | changes in depressive symptoms | Hamilton Depression Rating Scale (HDRS) | week 0, week 16, week 40 | |
Primary | changes in cognitive component of depressive syndrome | Beck Hopelessness Scale (BHS) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Primary | changes in HD-EEG | HD-EEG in resting state phase and a second phase with a task | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Primary | changes in fMRI | fMRI in resting state phase and a second phase with a task | month 0 (T0) | |
Primary | changes in HRV | HRV detection during hdEEG assessment | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Primary | psychiatric diagnosis | Structured Clinical Interview for DSM-5 (SCID-5) | month 0 (T0) | |
Primary | changing in depressive symptoms | Patient Health Questionnaire-9 (PHQ-9) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week | |
Secondary | addressing potentially traumatizing events | Traumatic Experience Checklist (TEC) | month 0 (T0) | |
Secondary | assessing childhood trauma | Childhood Trauma Questionnaire (CTQ) | month 0 (T0) | |
Secondary | evaluating the quality of relationships | Relationship Questionnaire (RQ) | month 0 (T0) | |
Secondary | changing in dissociative symptoms | Brief Dissociative Experiences Scale (DES-B) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in autonomic symptoms | Composite Autonomic Symptom Score (COMPASS-31) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in the emotional regulation | Difficulties in Emotion Regulation Scale (DERS) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in the dimensions of the emotional style | Emotional Style Questionnaire (ESQ) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in quality of sleep, in particular insomnia | Insomnia Severity Index (ISI) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in physical activity habits | International Physical Activity Questionnaire Short Form (IPAQ-SF) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in post-traumatic symptoms | International Trauma Questionnaire | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in suicidal thinking | Paykel Suicide Scale | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in stress | Perceived Stress Scale (PSS) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | changing in post-traumatic stress symptoms | PTSD Checklist for DSM-5 (PCL-5) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) | |
Secondary | assessing disability and functional impairment as a result of treatment | Sheehan Disability Scale for Treatment Induced Impairment (SDS-T) | 1 month time frame | |
Secondary | changing in anxiety symptoms | General Anxiety Disorder-7 (GAD-7) | month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |