Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-06 @ 6:02 PM
Study NCT ID:
NCT02325167
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2014-12-19', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'A reliable and valid 9-item measure of depression'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative Affect Scale (PANAS; Watson et al., 1988)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'two mood scales, one that measures positive affect and the other which measures negative affect'}, {'measure': 'Satisfaction with Life Scale (SWLS; Diener et al., 1985)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'a short 5-item instrument designed to measure global cognitive judgments of satisfaction with life'}, {'measure': 'World Health Organisation Quality-of-Life Scale (WHOQOL-BREF; Angermeyer et al., 2000)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'an abbreviated 26-item generic Quality of Life Scale developed through the World Health Organisation measuring physical health, psychological health, social relationships, and environment'}, {'measure': 'Numeric rating scale for mental stress and quality of life (NRS, range 0-10)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'a numeric scale used for the subjective measurement of mental stress and quality of life'}, {'measure': 'Generalised Anxiety Disorders-7 (GAD-7; Spitzer et al., 2006)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'a 7-item self-report measure designed to screen and assess the severity of generalised anxiety disorder symptoms'}, {'measure': 'Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter (FIMA; Seidl et al., 2014)', 'timeFrame': 'Baseline; 6 months follow-up', 'description': 'a german questionnaire for health-related resource use'}, {'measure': 'German version of the NCCN distress-thermometer (Mehnert et al., 2005)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'a subjective measurement of distress on a 0-10 scale'}, {'measure': 'General Health Questionnaire (GHQ-12, Goldberg et al., 1972)', 'timeFrame': 'Baseline; Post-treatment; 4 weeks follow-up; 6 months follow-up', 'description': 'a 12-item self-report measure of psychological morbidity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['informal caregivers', 'mental stress', 'quality of life', 'psychotherapeutic intervention'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the effectiveness of a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to prevent depression in informal caregivers of palliative patients.', 'detailedDescription': 'The investigators have developed and pilot-tested a short-term manualised individual psychotherapy, called Existential Behavioural Therapy (EBT), to reduce psychological distress in informal caregivers of palliative patients. The investigators propose to conduct a two-arm randomised controlled trial (RCT) to test the effectiveness of EBT against usual care for the reduction of distress and the promotion of quality of life.\n\nTwo one-to-one manualised psychotherapeutic sessions will be compared to a treatment-as-usual control group.Treatment-as-usual includes two supportive sessions.\n\nThe design will be an unblinded RCT consisting of two conditions (EBT and Treatment-as-usual), with assessment at pre- and post-treatment and follow-ups at four weeks and six months. The trial will take place in the Clinic of Palliative Care, University of Munich (Klinik und Poliklinik für Palliativmedizin der LMU München).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 21 years of age\n* informal caregivers of palliative patients at last stage of life and during bereavement;\n* fluent German language skills\n\nExclusion Criteria:\n\n* psychiatric conditions such as schizophrenic disorder, psychotic disorder etc.;\n* pronounced cognitive impairment e.g. delirium, dementia'}, 'identificationModule': {'nctId': 'NCT02325167', 'briefTitle': 'Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Short-term Existential Behavioural Therapy for Informal Caregivers of Palliative Patients: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '545-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EBT', 'interventionNames': ['Behavioral: EBT']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment-as-usual', 'interventionNames': ['Behavioral: treatment-as-usual']}], 'interventions': [{'name': 'EBT', 'type': 'BEHAVIORAL', 'description': 'participants assigned to the intervention arm will receive 2 manualised therapy sessions with focus on mindfulness and activating resources delivered by trained therapists at the Clinic of Palliative Care', 'armGroupLabels': ['EBT']}, {'name': 'treatment-as-usual', 'type': 'BEHAVIORAL', 'description': 'participants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care', 'armGroupLabels': ['Treatment-as-usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'country': 'Germany', 'facility': 'Ludwig Maximilians University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Martin Fegg, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik und Poliklinik für Palliativmedizin, Ludwig Maximilians Universität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stifterverband für die Deutsche Wissenschaft', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Martin Fegg', 'investigatorFullName': 'Martin Fegg', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}