Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-10 @ 12:39 PM
Study NCT ID:
NCT02752295
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2016-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of saliva cortisol', 'timeFrame': 'Change from baseline saliva sample at week 1 to end of study visit at week 38'}], 'secondaryOutcomes': [{'measure': 'Change of myeloperoxidase', 'timeFrame': 'Change from baseline at week 1 to end of study visit at week 38'}, {'measure': 'Change of interleukin-6', 'timeFrame': 'Change from baseline at week 1 to end of study visit at week 38'}, {'measure': 'Change of homocystein', 'timeFrame': 'Change from baseline at week 1 to end of study visit at week 38'}, {'measure': 'Change of psychometric stress-index (Questionnaire)', 'timeFrame': 'Change from baseline at week 1 to end of study visit at week 38'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Affective Disorders', 'Psychological Stress', 'Inflammation', 'Oxidative Stress', 'Anxiety Disorders', 'Mood Disorders', 'Emotions']}, 'referencesModule': {'references': [{'pmid': '24513877', 'type': 'BACKGROUND', 'citation': 'Pilger A, Haslacher H, Ponocny-Seliger E, Perkmann T, Bohm K, Budinsky A, Girard A, Klien K, Jordakieva G, Pezawas L, Wagner O, Godnic-Cvar J, Winker R. Affective and inflammatory responses among orchestra musicians in performance situation. Brain Behav Immun. 2014 Mar;37:23-9. doi: 10.1016/j.bbi.2013.10.018. Epub 2013 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'This study intents to determine who will benefit from an intensive brief stress coping intervention week (ISCIW) as secondary prevention for real world affective disorder patients.', 'detailedDescription': 'Affective disorders are associated with a substantial personal and socio-economic burden. This study evaluates an intensive brief stress-coping intervention week (ISCIW) as feasible follow-up treatment for real world patients who suffer from this highly prevalent and chronic stress-related disorders. Stress-associated blood (Interleukin-6, Homocystein, Myeloperoxidase), saliva cortisol and psychosocial screening parameters will be analyzed to determine who will benefit from the ISCIW. All patients were identified in a preventive medical screening before pre-treatment for at least three month as outpatient and the following inclusion to the follow-up ISCIW-trial at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria. For the three planed groups and interventions see interventions and arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affective or anxiety disorder DSM-IV diagnosis (structured interview, M.I.N.I. International Neuropsychiatric Interview )\n* Minimum 3-weeks previous therapeutic treatment as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria\n* Clinical Global Impression - Severity (CGI-S) score \\> 2 points\n* Minimum improvement of 1 CGI-S points as outpatient\n* Written informed consent\n\nExclusion Criteria:\n\n* More than 60 days away sick per year in the last year before intervention\n* Therapy adherence as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria\n* Work Ability Index (WAI) score \\< 25 points\n* Major neurological or cognitive deficits\n* Current psychotic symptoms\n* Current or previous DSM-IV diagnosis of substance dependence, except for nicotine or current substance abuse\n* Failures to comply with the study protocol or to follow the instructions of the study team\n* Currently requested application for retirement\n* Middle to high suicidal tendency in the M.I.N.I.-examination'}, 'identificationModule': {'nctId': 'NCT02752295', 'acronym': 'ISCIW', 'briefTitle': 'Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients', 'orgStudyIdInfo': {'id': 'ISCIW trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Waiting list, intervention after EOS', 'description': 'control group / waiting list one week stress-coping intervention planned after end of study (EOS) without one week stress-coping intervention AND without an additional two days follow-up care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stress-coping week without follow-up', 'description': 'active comparator with one week stress-coping intervention BUT without an additional two days follow-up weekend', 'interventionNames': ['Behavioral: stress-coping week']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stress-coping week with follow-up', 'description': 'active comparator with one week stress-coping intervention AND with an additional two days follow-up weekend', 'interventionNames': ['Behavioral: stress-coping week', 'Behavioral: additional two days follow-up weekend']}], 'interventions': [{'name': 'stress-coping week', 'type': 'BEHAVIORAL', 'description': 'The multidisciplinary team will offer Mindfulness-Based Stress Reduction (MBSR), group psychotherapy (resilience, Cognitive Behavioral Analysis System of Psychotherapy CBASP, psychodynamic therapy), relaxation training, nutrition course, stress-coping and physical training in a group setting.', 'armGroupLabels': ['Stress-coping week with follow-up', 'Stress-coping week without follow-up']}, {'name': 'additional two days follow-up weekend', 'type': 'BEHAVIORAL', 'description': 'A two-days follow-up which recapitulates previous treatment elements.', 'armGroupLabels': ['Stress-coping week with follow-up']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanatorium Hera Vienna', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prim.Priv. Doz. Dr.', 'investigatorFullName': 'Robert Winker', 'investigatorAffiliation': 'Medical University of Vienna'}}}}