Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT02003261
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'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': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Global Assessment of Functioning(GAF)', 'timeFrame': '10 weeks, 21 weeks, and 43 weeks'}, {'measure': 'Disorder specific measures', 'timeFrame': '10 weeks, 21 weeks, and 43 weeks', 'description': 'Participants will be answered some of the following measures in accord with their diagnoses; Beck Depression Inventory-II for Depressive Disorders, Panic Disorder Severity Scale for Panic Disorder, Penn-State Worry Questionnaire for Generalized Anxiety Disorder, Impact of Event Scale-Revised for Post-Traumatic Stress Disorder, Yale-Brown Obsessive Compulsive Scale for Obsessive Compulsive Disorder and Fear Questionnaire for Agora Phobia.'}, {'measure': 'Quality of Life(EQ-5D)', 'timeFrame': '10 weeks, 21 weeks, and 43 weeks'}, {'measure': 'Sheehan Disability Scale(SDISS)', 'timeFrame': '10 weeks, 21 weeks, and 43 weeks'}, {'measure': 'Sense of Authenticity Scale(SOA)', 'timeFrame': '10 weeks, 21 weeks, and 43 weeks'}, {'measure': 'Overall Anxiety Severity and Impairment Scale(OASIS)', 'timeFrame': '10 weeks, 21 weeks, 43 weeks and at every UP sessions'}, {'measure': 'Overall Depression Severity and Impairment Scale(ODSIS)', 'timeFrame': '10 weeks, 21 weeks, 43 weeks and at every UP sessions'}, {'measure': 'Eysenck Personality Questionnaire- Revised Short version, Neuroticism(EPQR-S)', 'timeFrame': '10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15'}, {'measure': 'Anxiety Sensitivity Index-III(ASI-III)', 'timeFrame': '10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15'}, {'measure': 'Emotion Regulation Skills Questionnaire(ERSQ)', 'timeFrame': '10 weeks, 21 weeks, 43 weeks and at UP session #5 and #15'}, {'measure': 'Credibility/Expectancy Questionnaire(CEQ)', 'timeFrame': '2 weeks'}, {'measure': 'Session Rating Scale(SRS V.3.0)', 'timeFrame': 'UP session at #1, 5, 10, and 15'}, {'measure': 'Homework Compliance Scale(HCS)', 'timeFrame': 'UP session at #1, 5, 10, and 15'}, {'measure': 'Adverse Events', 'timeFrame': 'From 1 week to 21 weeks', 'description': 'Adverse Events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.'}, {'measure': 'GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)', 'timeFrame': '10 weeks, 43 weeks'}, {'measure': 'Hamilton Anxiety Rating Scale 14 item(HAM-A)', 'timeFrame': '10 weeks and 43 weeks'}, {'measure': 'Clinical Global Impression- Severity(CGI-S)', 'timeFrame': '10 weeks, 43 weeks'}, {'measure': 'Clinical Global Impression-Improvement(CGI-I)', 'timeFrame': '10 weeks, 43 weeks'}, {'measure': 'Psychiatric diagnosis assessed by SCID', 'timeFrame': '43 weeks'}, {'measure': 'Emotion Exposure Scale (EES)', 'timeFrame': '10 weeks, 21 weeks, 43 weeks'}, {'measure': 'Understanding of Treatment Rational of Unified Protocol (TRUP)', 'timeFrame': '10 weeks, 21 weeks, and 43 weeks'}, {'measure': 'Magnetic Resonance Imaging(MRI)', 'timeFrame': '21 weeks, 43 weeks'}], 'primaryOutcomes': [{'measure': 'GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)', 'timeFrame': '21 weeks'}], 'secondaryOutcomes': [{'measure': 'Hamilton Anxiety Rating Scale 14 item(HAM-A)', 'timeFrame': '21 weeks'}, {'measure': 'Clinical Global Impression- Severity(CGI-S)', 'timeFrame': '21 weeks'}, {'measure': 'Clinical Global Impression-Improvement(CGI-I)', 'timeFrame': '21 weeks'}, {'measure': 'Responder Status assessed by GRID-HAMD', 'timeFrame': '21 weeks', 'description': 'Reduction in GRID-HAMD score of at least 50% compared with baseline'}, {'measure': 'Remission of symptoms assessed by GRID-HAMD', 'timeFrame': '21 weeks', 'description': 'GRID-HAMD score of less than 8'}, {'measure': 'Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)', 'timeFrame': '21 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anxiety Disorders', 'Depressive Disorders']}, 'referencesModule': {'references': [{'pmid': '26987315', 'type': 'DERIVED', 'citation': 'Ito M, Okumura Y, Horikoshi M, Kato N, Oe Y, Miyamae M, Hirabayashi N, Kanie A, Nakagawa A, Ono Y. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Mar 18;16:71. doi: 10.1186/s12888-016-0779-8.'}]}, 'descriptionModule': {'briefSummary': 'This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.', 'detailedDescription': 'Participants with depressive or anxiety disorders will be randomized to either Unified Protocol with Treatment-As-Usual or Wail-list with Treatment-As-Usual. Intervention period will be 20-week and the follow-up period will be 43 week from registration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID.\n* Depressive and anxiety symptoms is mild or more severe (GRID-HAMD \\>= 8).\n* Ages 20 years or older, and 65 years or younger at screening.\n* Subjects who give full consent in the participation of the study.\n\nExclusion Criteria:\n\n* No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID\n* No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID\n* No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.)\n* No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline.\n* Evidence of unable to participate half or more of the intervention phase.\n* No structured psychotherapy during at baseline.\n* Other relevant reason decided by the investigators.'}, 'identificationModule': {'nctId': 'NCT02003261', 'briefTitle': 'Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)', 'organization': {'class': 'OTHER', 'fullName': 'National Center of Neurology and Psychiatry, Japan'}, 'officialTitle': 'An Assessor-blinded, Randomized, 20-week, Parallel-group, Superiority Study to Compare the Efficacy of Transdiagnostic Cognitive Behavioral Therapy Versus Waiting-list in Depressive and Anxiety Symptoms of Depressive and Anxiety Disorders', 'orgStudyIdInfo': {'id': 'KAKENHI 25705018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unified Protocol with Treatment As Usual', 'description': 'Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual.', 'interventionNames': ['Behavioral: Unified Protocol with Treatment As Usual', 'Other: Treatment As Usual']}, {'type': 'OTHER', 'label': 'Waitlist Control with Treatment As Usual', 'description': 'Waitlist participants will not receive treatment during a 20-week waitlist period, but will receive the unified protocol immediately following the 20 week waiting period. During the waitlist period, the waitlist participants continue the treatment as usual.', 'interventionNames': ['Other: Treatment As Usual']}], 'interventions': [{'name': 'Unified Protocol with Treatment As Usual', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Therapy'], 'description': 'Unified Protocol(UP) is a transdiagnostic cognitive-behavioral therapy for depressive and anxiety disorders, which is developed by Dr. Barlow and his colleagues at Boston university.\n\nUP is weekly, face to face, individual psychotherapy consisting of 9 to 20 sessions. Average session number is 16 sessions. Contents of the treatment includes motivational enhancement, psychoeducation of treatment rationale and emotion, emotion awareness training, cognitive reappraisal, avoidance and emotion driven behaviors, interoceptive exposure and emotion exposure.', 'armGroupLabels': ['Unified Protocol with Treatment As Usual']}, {'name': 'Treatment As Usual', 'type': 'OTHER', 'description': 'Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.', 'armGroupLabels': ['Unified Protocol with Treatment As Usual', 'Waitlist Control with Treatment As Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '187-8551', 'city': 'Kodaira', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Center of Neurology and Psychiatry', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}], 'overallOfficials': [{'name': 'Masaya Ito, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Cognitive-Behavior Therapy and Research, National Center of Neurology and Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center of Neurology and Psychiatry, Japan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of dissemination and training at National Center of Cognitive-Behavior Therapy and Research', 'investigatorFullName': 'Masaya ITO', 'investigatorAffiliation': 'National Center of Neurology and Psychiatry, Japan'}}}}