Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 6:40 AM
Study NCT ID:
NCT01620866
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057169', 'term': 'Eye Movement Desensitization Reprocessing'}], '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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-18', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-06-13', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome of this study is a statistically significant reduction in the YMRS and/or HDRS in the EMDR group compared with the TAU group.', 'timeFrame': '3 months and 6 months', 'description': 'Patients with subsydromal symptoms, objectified by the YMRS and HDRS, are included in the study. After randomization to EMDR or TAU, group differences in changes in the YMRS and HRDS are measured at visit after intervention (3 months) and at follow-up (6 months). The hypothesize is that the EMDR group will statistically improve in both affective scales when compared to the TAU group.'}], 'secondaryOutcomes': [{'measure': 'The EMDR group improves statistically significant in trauma load when compared to TAU.', 'timeFrame': '3 months and 6 months', 'description': 'Secondary outcome measure includes changes in trauma scales (IES, CAPS)from baseline to 3 months and 6 months.'}, {'measure': 'The EMDR group improves statistically significant in cognitive tests when compared to TAU.', 'timeFrame': '3 months and 6 months', 'description': 'Subjects underwent a neuropsychologcial battery to test various cognitive domains.'}, {'measure': 'The EMDR group improves statistically significant in functioning when compared to TAU.', 'timeFrame': '3 months and 6 months', 'description': 'All subjects were evaluated with respect to their functioning using the FAST, a validated scale of functioning in bipolar disorder.'}, {'measure': 'The EMDR group improves statistically significant in quality of life when compared to TAU.', 'timeFrame': '3 months and 6 months', 'description': 'Possible changes of Quality of life were tested in all subjects as well, using the SF-36.'}, {'measure': 'Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.', 'timeFrame': '3 months and 6 months', 'description': 'Levels of BDNF are lower in bipolar patients, and even lower when traumatized, when compared to the general population. We aimed to find higher levels of BDNF in the EMDR group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EMDR', 'bipolar disorder', 'trauma', 'subsyndromal symptoms', 'PTSD'], 'conditions': ['Bipolar Disorder', 'PTSD']}, 'referencesModule': {'references': [{'pmid': '17543031', 'type': 'BACKGROUND', 'citation': "Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x."}, {'pmid': '17636720', 'type': 'BACKGROUND', 'citation': 'Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bipolar I or II disorder following DSM-IV criteria\n* Instable, subsyndromal course defined as at evaluation baseline (HAMD \\> 8 \\< 15 and/or YMRS \\> 7 \\< 14)\n* Good adherence to pharmacological treatment\n* Major or minor traumatic life-events\n* EMDR therapists \\> 3 years experience\n* Able to sign informed consent\n\nExclusion Criteria:\n\n* Major affective episode in last 3 months\n* Active drug abuse/dependency\n* Neurological disease\n* Suicidal thoughts/ideation\n* Prior treatment EMDR\n* DES \\> 25'}, 'identificationModule': {'nctId': 'NCT01620866', 'acronym': 'BET', 'briefTitle': 'A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients', 'organization': {'class': 'OTHER', 'fullName': 'FIDMAG Germanes Hospitalàries'}, 'officialTitle': 'A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma', 'orgStudyIdInfo': {'id': 'BET-study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMDR', 'interventionNames': ['Other: Eye Movement Desensitization Reprocessing (EMDR)']}, {'type': 'NO_INTERVENTION', 'label': 'TAU', 'description': 'Treatment as usual (TAU)'}], 'interventions': [{'name': 'Eye Movement Desensitization Reprocessing (EMDR)', 'type': 'OTHER', 'description': 'EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.', 'armGroupLabels': ['EMDR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'FIDMAG', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Benedikt L Amann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FIDMAG Germanes Hospitalàries'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FIDMAG Germanes Hospitalàries', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher', 'investigatorFullName': 'Benedikt Amann', 'investigatorAffiliation': 'FIDMAG Germanes Hospitalàries'}}}}