Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-09 @ 6:50 PM
Study NCT ID:
NCT03972033
Status:
UNKNOWN
Last Update Posted:
2022-03-14
First Post:
2019-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT Comparing EMDR and CBT for Treatment of Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057169', 'term': 'Eye Movement Desensitization Reprocessing'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D003887', 'term': 'Desensitization, Psychologic'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Outcomes assessors doesn't know the patient group assignment."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The design of the study is a randomized controlled clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in depressive symptoms', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).', 'description': 'Beck Depression Inventory II (BDI-II)'}, {'measure': 'changes in depressive symptoms', 'timeFrame': 'week 0, week 16, week 40', 'description': 'Hamilton Depression Rating Scale (HDRS)'}, {'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)', 'description': 'Beck Hopelessness Scale (BHS)'}, {'measure': 'changes in HD-EEG', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'HD-EEG in resting state phase and a second phase with a task'}, {'measure': 'changes in fMRI', 'timeFrame': 'month 0 (T0)', 'description': 'fMRI in resting state phase and a second phase with a task'}, {'measure': 'changes in HRV', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'HRV detection during hdEEG assessment'}, {'measure': 'psychiatric diagnosis', 'timeFrame': 'month 0 (T0)', 'description': 'Structured Clinical Interview for DSM-5 (SCID-5)'}, {'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', 'description': 'Patient Health Questionnaire-9 (PHQ-9)'}], 'secondaryOutcomes': [{'measure': 'addressing potentially traumatizing events', 'timeFrame': 'month 0 (T0)', 'description': 'Traumatic Experience Checklist (TEC)'}, {'measure': 'assessing childhood trauma', 'timeFrame': 'month 0 (T0)', 'description': 'Childhood Trauma Questionnaire (CTQ)'}, {'measure': 'evaluating the quality of relationships', 'timeFrame': 'month 0 (T0)', 'description': 'Relationship Questionnaire (RQ)'}, {'measure': 'changing in dissociative symptoms', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'Brief Dissociative Experiences Scale (DES-B)'}, {'measure': 'changing in autonomic symptoms', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'Composite Autonomic Symptom Score (COMPASS-31)'}, {'measure': 'changing in the emotional regulation', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'Difficulties in Emotion Regulation Scale (DERS)'}, {'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)', 'description': 'Emotional Style Questionnaire (ESQ)'}, {'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)', 'description': 'Insomnia Severity Index (ISI)'}, {'measure': 'changing in physical activity habits', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'International Physical Activity Questionnaire Short Form (IPAQ-SF)'}, {'measure': 'changing in post-traumatic symptoms', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'International Trauma Questionnaire'}, {'measure': 'changing in suicidal thinking', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'Paykel Suicide Scale'}, {'measure': 'changing in stress', 'timeFrame': 'month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)', 'description': 'Perceived Stress Scale (PSS)'}, {'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)', 'description': 'PTSD Checklist for DSM-5 (PCL-5)'}, {'measure': 'assessing disability and functional impairment as a result of treatment', 'timeFrame': '1 month time frame', 'description': 'Sheehan Disability Scale for Treatment Induced Impairment (SDS-T)'}, {'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', 'description': 'General Anxiety Disorder-7 (GAD-7)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'neurobiology of emotions', 'Cognitive Behavioral Therapy', 'Eye Movement Desensitization and Reprocessing', 'trauma', 'psychotherapy'], 'conditions': ['Eye Movement Desensitization and Reprocessing', 'Cognitive Behavioral Therapy', 'Neurobiological Processing', 'Depression', 'Functional Magnetic Resonance Imaging', 'High Definition Electroencefalography', 'Heart Rate Variability']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. a diagnosis of Major Depressive Disorder, single episode or recurrent, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);\n2. a score of at least 20 on Beck's Depression Inventory-II (BDI-II);\n3. having received ADM treatment with a stable dose for at least six weeks and maintained stable during treatment;\n4. legal capacity to consent to the treatment.\n\nExclusion Criteria:\n\n1. diagnosis of current PTSD (assessed with MINI-Plus and the International Trauma Questionnaire - ITQ, Cloitre et al., 2018);\n2. diagnosis of complex PTSD (assessed with the ITQ);\n3. history of psychotic symptoms or schizophrenia;\n4. bipolar disorder or dementia;\n5. cluster A and B severe personality disorders;\n6. dissociative symptoms (DES-B score \\>2);\n7. any substance-related abuse or dependence disorder (except those involving nicotine) in the 6 months prior to the study;\n8. a serious, unstable medical condition;\n9. a severely unstable social and economic condition (e.g. no fixed abode; job loss without any other source of income);\n10. being pregnant;\n11. acute suicidality that needs hospitalization"}, 'identificationModule': {'nctId': 'NCT03972033', 'briefTitle': 'RCT Comparing EMDR and CBT for Treatment of Resistant Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Multicenter RCT Comparing EMDR and CBT Efficacy for Treatmen of Resistant Depression', 'orgStudyIdInfo': {'id': 'EMDRvsCBT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye Movement Desensitization and Reprocessing', '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.\n\nIn 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.', 'interventionNames': ['Behavioral: EMDR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy', '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.', 'interventionNames': ['Behavioral: CBT']}], 'interventions': [{'name': 'EMDR', 'type': 'BEHAVIORAL', 'otherNames': ['Eye Movement Desensitization and Reprocessing'], '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.\n\nAs a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm.', 'armGroupLabels': ['Eye Movement Desensitization and Reprocessing']}, {'name': 'CBT', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Therapy'], '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.\n\nAs a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm.', 'armGroupLabels': ['Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Ostacoli, Assistant Professor', 'role': 'CONTACT', 'email': 'luca.ostacoli@unito.it', 'phone': '3335613155'}], 'facility': 'AOU Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Luca Ostacoli, Associate Professor', 'role': 'CONTACT', 'email': 'luca.ostacoli@unito.it', 'phone': '3335613155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'EMDR Europe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'luca ostacoli', 'investigatorAffiliation': 'University of Turin, Italy'}}}}