Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-05 @ 6:05 PM
Study NCT ID:
NCT02529358
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Text Message Based Maintenance Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive Symptom load', 'timeFrame': '6 weeks post treatment (after intervention)', 'description': 'Measurement of depressive symptom severity with Beck Depression Inventory'}, {'measure': 'Emotion Regulation Competence', 'timeFrame': '6 weeks post treatment (after intervention)', 'description': 'Emotion Regulation Competence measured by SERSA'}], 'secondaryOutcomes': [{'measure': 'Psychopathological symptomatology', 'timeFrame': '10 weeks Follow-Up', 'description': 'Measurement of psychopathological symptomatology with self report questionnaires'}, {'measure': 'Depressive Symptom load', 'timeFrame': '10 weeks Follow-Up', 'description': 'Measurement of depressive symptom severity with Beck Depression Inventory'}, {'measure': 'Emotion Regulation Competence', 'timeFrame': '10 weeks follow up', 'description': 'Emotion Regulation Competence measured by SERSA'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Maintenance intervention', 'Text messages', 'Emotion Regulation'], 'conditions': ['Mental Disorders']}, 'descriptionModule': {'briefSummary': 'The study presents findings from a randomized clinical trial evaluating the effects of text messages encouraging short emotion regulation exercises on the course of psychopathological symptoms after inpatient treatment for depression. In this context, the study also compares the effectiveness of standardized versus personalized text messages.', 'detailedDescription': "Introduction: The importance of aftercare and maintenance intervention to reduce psychopathology, prevent relapses and stabilize the effects of inpatient cognitive behavioral therapy is well proven. In order to attain a high reachability rate among the patients, simple, quick and low cost methods should be used. Modern communication technologies, such as mobile phones provide this opportunity. Therefore, the current study explores how modern communication technologies can be used as a support system in psychotherapy to realize a reduced psychopathology.\n\nMethods: A total of 150 patients participated in a transdiagnostical 6-weeks text messaging maintenance intervention. The text messages were based on emotion regulation skills. The effectiveness of different variants of the text messages was studied in a randomized controlled trial, comparing the impact on the patient's psychopathological outcome to receiving personalized text messages versus standardized text messages."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good knowledge of the german language\n* owning a mobile phone\n\nExclusion Criteria:\n\n* brain damage\n* personality disorders'}, 'identificationModule': {'nctId': 'NCT02529358', 'briefTitle': 'Text Message Based Maintenance Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}, 'officialTitle': 'Evaluation of a Transdiagnostic Text Message Based Maintenance Intervention After Inpatient Cognitive Behavioural Therapy', 'orgStudyIdInfo': {'id': 'SMS-MI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EG stand', 'description': 'Standardized text messages', 'interventionNames': ['Behavioral: standardized text messages']}, {'type': 'EXPERIMENTAL', 'label': 'EG ind', 'description': 'Personalized text messages', 'interventionNames': ['Behavioral: Personalized text messages']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Standardized text messages after 10 weeks', 'interventionNames': ['Behavioral: Standardized text messages after 10 weeks']}], 'interventions': [{'name': 'standardized text messages', 'type': 'BEHAVIORAL', 'description': 'Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies', 'armGroupLabels': ['EG stand']}, {'name': 'Personalized text messages', 'type': 'BEHAVIORAL', 'description': 'Patients write their own messages', 'armGroupLabels': ['EG ind']}, {'name': 'Standardized text messages after 10 weeks', 'type': 'BEHAVIORAL', 'description': 'Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies which are send to the patients 10 weeks after completing inpatient therapy', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34454', 'city': 'Bad Arolsen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Schön Klinik', 'geoPoint': {'lat': 51.37982, 'lon': 9.01445}}], 'overallOfficials': [{'name': 'Sandra Schlicker, Dipl.-Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}, {'name': 'Matthias Berking, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philipps University Marburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dipl.-Psych.', 'investigatorFullName': 'Dipl.-Psych. Sandra Schlicker', 'investigatorAffiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg'}}}}