Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-02 @ 10:53 PM
Study NCT ID:
NCT01786733
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2013-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral Activation - From Inpatient to Outpatient Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2013-01-29', 'studyFirstSubmitQcDate': '2013-02-05', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)', 'timeFrame': 'Weekly during treatment period of 6 weeks', 'description': 'MADRS-S is a 9 item self report measure of depressive symptoms.'}, {'measure': 'Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)', 'timeFrame': '24 hours'}, {'measure': 'Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)', 'timeFrame': '6 months'}, {'measure': 'Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in EuroQol 5 Dimension Scale (EQ5D)', 'timeFrame': '24 hours', 'description': 'The EQ5D is a self rating measure for health-related quality of life. It consists of 5 health state dimensions (mobility, self-care, usual activity, pain/discomfort and anxiety/depression) on which the respondent has to indicate his own health state.'}, {'measure': 'Change from baseline in EuroQol 5 Dimension Scale (EQ5D)', 'timeFrame': '6 months'}, {'measure': 'Change from baseline in EuroQol 5 Dimension Scale (EQ5D)', 'timeFrame': '12 months'}, {'measure': 'Change from baseline in Alcohol Disorders Identification Test (AUDIT)', 'timeFrame': '24 hours', 'description': '10 item screening instrument for alcohol use'}, {'measure': 'Change from baseline in Alcohol Disorders Identification Test (AUDIT)', 'timeFrame': '6 months', 'description': '10 item screening instrument for alcohol use'}, {'measure': 'Change from baseline in Alcohol Disorders Identification Test (AUDIT)', 'timeFrame': '12 months', 'description': '10 item screening instrument for alcohol use'}, {'measure': 'Change from baseline in The Sheehan Disability Scale (SDS)', 'timeFrame': '24 hours', 'description': 'The SDS is a three-item, self-report scale used to assess functioning in three areas of life (work, social life, and family life). Each item is rated on an 11-point Likert-type scale ranging from zero (no impairment) to 10 (extreme impairment), while the total range extends from zero to 30 points.'}, {'measure': 'Change from baseline in The Sheehan Disability Scale (SDS)', 'timeFrame': '6 months'}, {'measure': 'Change from baseline in The Sheehan Disability Scale (SDS)', 'timeFrame': '12 months'}, {'measure': 'Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)', 'timeFrame': '24 hours', 'description': '9 item self rating instrument of activation and avoidance.'}, {'measure': 'Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)', 'timeFrame': 'Weekly druing treatment period of 6 weeks', 'description': '9 item self rating instrument of activation and avoidance.'}, {'measure': 'Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)', 'timeFrame': '6 months', 'description': '9 item self rating instrument of activation and avoidance.'}, {'measure': 'Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)', 'timeFrame': '12 months', 'description': '9 item self rating instrument of activation and avoidance.'}, {'measure': 'Change from baseline in sick leave and employment status', 'timeFrame': '6 months', 'description': 'Interview questions regarding Days on/type of/level of sick leave Interview questions regarding employment status and hours of work per week'}, {'measure': 'Change from baseline in sick leave and employment status', 'timeFrame': '12 months'}, {'measure': 'Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)', 'timeFrame': '24 hours', 'description': 'The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose psychiatric disorders in accordance with the Diagnostic and Statistical Manual (DSM-IV) and International Classification of Diseases (ICD-10).'}, {'measure': 'Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)', 'timeFrame': '6 months', 'description': 'The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.'}, {'measure': 'Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)', 'timeFrame': '12 months', 'description': 'The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.'}, {'measure': 'Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': '24 hours', 'description': 'Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.'}, {'measure': 'Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': '6 months', 'description': 'Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.'}, {'measure': 'Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': '12 months', 'description': 'Interview for clinician rating of depressive symptoms. 10 items each ranging from 0-6.'}, {'measure': 'Change from baseline in Global Assessment of Functioning (GAF)', 'timeFrame': '24 hours', 'description': 'Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.'}, {'measure': 'Change from baseline in Global Assessment of Functioning (GAF)', 'timeFrame': '6 months', 'description': 'Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.'}, {'measure': 'Change from baseline in Global Assessment of Functioning (GAF)', 'timeFrame': '12 months', 'description': 'Clinicians and patients rate severity of symptoms and functioning on a scale ranging from 1-100.'}, {'measure': 'Change from baseline in Clinical Global Impression (CGI)', 'timeFrame': '24 hours', 'description': "Clinician rates patients' psychiatric problems in regards to severity on a scale from 0-6. After treatment the clinician rates the degree of change in relation to the first assessment."}, {'measure': 'Change from baseline in Clinical Global Impression (CGI)', 'timeFrame': '6 months'}, {'measure': 'Change from baseline in Clinical Global Impression (CGI)', 'timeFrame': '12 months'}, {'measure': 'Change from baseline in Usage of mental health care', 'timeFrame': '6 months', 'description': 'Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.'}, {'measure': 'Change from baseline in Usage of mental health care', 'timeFrame': '12 months', 'description': 'Re-admissions (frequency/length of admissions), outpatient visits, usage of psychiatric medications. Data from medical charts.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Inpatient Psychiatry', 'Continuity of Care', 'Behavioral Activation', 'Depression'], 'conditions': ['Inpatient Facility Diagnoses', 'Psychiatric Disorders', 'Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of Behavioral Activation and Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts during inpatient care and can continue in an outpatient facility if the patients are discharged before 12 sessions has been completed.', 'detailedDescription': 'Psychiatric inpatient care is reserved for individuals with the most acute mental health problems. The period after discharge is associated with increased risk for relapse, non-adherence and suicide. Delivering high quality psychosocial interventions during and after acute psychiatric inpatient care is known to be a difficult challenge. This study will investigate the effectiveness of adding either Behavioral Activation or Supportive Therapy to the standard acute psychiatric inpatient care. Subjects with different psychiatric diagnoses and elevated depressive symptoms are assessed and randomized after admission. Therapists from the nearest outpatient facility initiate 12 sessions of Behavioral Activation or Supportive Therapy as soon as possible. The 12 sessions are delivered twice weekly at the inpatient unit or at the outpatient facility, depending on whether the patient is admitted or discharged. Treatment as usual interventions(medications, nursing etc.) are not manipulated in the study. The main assessment points are pre-, post, 6 months follow-up and 12 months follow-up. The main outcome measure and some process measures are also administered at session 3, 6 and 9.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted into one of four acute psychiatric inpatient units in Dalarna\n* MADRS-S 20 and above at acute admission and and after 2-3 days on the ward\n* Psychiatric disorder according to M.I.N.I (Sheehan et al., 1998)\n* Read and Speak Swedish\n\nExclusion Criteria:\n\n* Acute psychotic symptoms\n* Acute manic symptoms\n* Confusion\n* Primary eating disorder\n* Primary alcohol or substance abuse disorder\n* Self rated score on AUDIT (Saunders et al., 1993)of 20 or greater\n* Mental retardation'}, 'identificationModule': {'nctId': 'NCT01786733', 'briefTitle': 'Behavioral Activation - From Inpatient to Outpatient Services', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services - A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy', 'orgStudyIdInfo': {'id': 'Dnr 2012 / 226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Activation', 'description': 'Behavioral Activation + Treatment as Usual. 12 sessions twice weekly (i.e. 6 weeks). Individual therapy. Therapy is initiated during inpatient admission and continue after discharge. Protocol aimed at increased activation towards goals and personal values and decreased avoidance behaviors.', 'interventionNames': ['Behavioral: Behavioral Activation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Therapy', 'description': 'Supportive Therapy + Treatment as Usual. 12 sessions twice weekly (i.e. 6 weeks). Individual therapy. Therapy is initiated during inpatient admission and continue after discharge. Protocol aimed at providing psychological non-directive support.', 'interventionNames': ['Behavioral: Supportive Therapy']}], 'interventions': [{'name': 'Behavioral Activation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Behavioral Activation']}, {'name': 'Supportive Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Supportive Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Per Söderberg, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden'}, {'name': 'Lisa Ekselius, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Sweden'}, {'name': 'Stefan Tungström, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Adult Psychiatric Clinic of Landstinget Dalarna, Sweden'}, {'name': 'Timo Hursti, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Department of Psychology, Uppsala University, Sweden'}, {'name': 'Fredrik Folke, PhD-student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD-student', 'investigatorFullName': 'Fredrik Folke', 'investigatorAffiliation': 'Uppsala University'}}}}