Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-03-05 @ 10:59 AM
Study NCT ID:
NCT02397850
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2015-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Telephone-based Continuation Treatment for Patients With Chronic Depression.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients dropping out of treatment', 'timeFrame': '6 months'}, {'measure': 'change of depressive symptoms from baseline to posttreatment', 'timeFrame': '6 months', 'description': 'assessed by the Patient Health Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression, chronic, psychotherapy, telephone, feasibility'], 'conditions': ['Chronic Depressive Disorder']}, 'descriptionModule': {'briefSummary': "There is a high risk for relapse in people suffering from depression. Studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. Therefore, this pilot study is aimed to investigate the feasibility of a continuation psychotherapy over 6 months, to support people suffering from chronic forms of depression in their daily life. The investigated continuation therapy itself includes about one telephone call per month (therapist - patient), focussing on the integration of strategies into the patient's daily routine. The patients receive either 30 minutes or 50 minutes phone calls. On the one hand, these phone calls are supported by a workbook for patients containing psychoeducative elements, strategies and exercises. On the other hand, the therapist's work is based on a manual containing several modules and strategies. Both tools (workbook, manual) are understood as a framework, using the appropriate sections according to the patient's needs. As a result, the patients receive a continuation treatment which is appropriate and adapted to their individual situation.\n\nThe main purpose of this pilot study is to evaluate the feasibility of a telephone based psychotherapeutic continuation treatment with a small sample of 20 patients suffering from chronic depression. In case of promising results the effectiveness of this kind of treatment is going to be investigated within a comparative trial (including face-to-face intervention, no intervention)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Diagnosis of chronic (300.4) or recurrent (296.31-3) depression (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)\n* Currently in partial or full remission\n* Previous psychotherapy (acute treatment; some kind of cognitive-behavioral therapy)\n* adequate knowledge of German language\n* in case of taking antidepressants: long-term and stable dosage (with unchanged taking since 3 months at least)\n\nExclusion Criteria:\n\n* acute suicidality\n* psychotic symptoms\n* severe cognitive impairments\n* in case of taking antidepressants: anticipated stopping medication within treatment period (6 months)'}, 'identificationModule': {'nctId': 'NCT02397850', 'briefTitle': 'Development of a Telephone-based Continuation Treatment for Patients With Chronic Depression.', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Optimizing Psychotherapeutic Aftercare for Patients Suffering From Chronic/Recurrent Depression: Development and First Evaluation of a Telephone-based Continuation Treatment (Pilot Study).', 'orgStudyIdInfo': {'id': 'WATZKE-892'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30 min or 50 min', 'description': 'Patients receive either seven 30 minutes or 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)', 'interventionNames': ['Behavioral: phone calls 30 min', 'Behavioral: phone calls 50 min']}], 'interventions': [{'name': 'phone calls 30 min', 'type': 'BEHAVIORAL', 'description': 'Patients receive either seven 30 minutes phone calls over 6 months (psychotherapy/continuation treatment)', 'armGroupLabels': ['30 min or 50 min']}, {'name': 'phone calls 50 min', 'type': 'BEHAVIORAL', 'description': 'Patients receive either seven 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)', 'armGroupLabels': ['30 min or 50 min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitätsSpital Zürich Klinik für Psychiatrie und Psychotherapie Ambulatorium', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Birgit Watzke, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}