Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-26 @ 8:07 PM
Study NCT ID:
NCT01606592
Status:
COMPLETED
Last Update Posted:
2021-03-12
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychotherapy Outcome and Self-selection Effects in Panic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-05-23', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on Panic Disorder Severity Scale (PDSS; Shear et al., 1997)', 'timeFrame': 'Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination'}, {'measure': 'Change in occupational status', 'timeFrame': 'Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination'}, {'measure': 'Change in absence from work due to sickness', 'timeFrame': 'Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination'}], 'secondaryOutcomes': [{'measure': 'Change on Mobility Inventory for Agoraphobia (MI, Chambless et al, 1985)', 'timeFrame': 'Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination'}, {'measure': 'Change in health care utilization (number of medical contacts, and emergency visits, medication)', 'timeFrame': 'Growth curve analysis across 3 months before intake, intake and follow up at termination and 6, 12 and 24 months after termination'}, {'measure': 'Change on Clinical Outcomes in Routine Evaluation Scale(CORE; Evans et al., 2000)', 'timeFrame': 'Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination'}, {'measure': 'Change on Montgomery Asberg Depression Rating Scale (MADRS-S; Montgomery & Asberg, 1979)', 'timeFrame': 'Growth curve analysis across intake and follow up at termination and 6, 12 and 24 months after termination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Panic Disorder (With or Without Agoraphobia)']}, 'referencesModule': {'references': [{'pmid': '34591549', 'type': 'DERIVED', 'citation': 'Nilsson T, Falkenstrom F, Perrin S, Svensson M, Johansson H, Sandell R. Exploring termination setback in a psychodynamic therapy for panic disorder. J Consult Clin Psychol. 2021 Sep;89(9):762-772. doi: 10.1037/ccp0000678.'}, {'pmid': '33148129', 'type': 'DERIVED', 'citation': 'Svensson M, Nilsson T, Perrin S, Johansson H, Viborg G, Sandell R. Preferences for panic control treatment and panic focused psychodynamic psychotherapy for panic disorder - who chooses which and why? Psychother Res. 2021 Jun;31(5):644-655. doi: 10.1080/10503307.2020.1839686. Epub 2020 Nov 5.'}, {'pmid': '30636466', 'type': 'DERIVED', 'citation': 'Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S, Sandell R. Psychometric analysis of the Swedish panic disorder severity scale and its self-report version. Nord J Psychiatry. 2019 Jan;73(1):58-63. doi: 10.1080/08039488.2018.1554699. Epub 2019 Jan 14.'}, {'pmid': '25873067', 'type': 'DERIVED', 'citation': 'Sandell R, Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S. The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial. Trials. 2015 Mar 31;16:130. doi: 10.1186/s13063-015-0656-7.'}]}, 'descriptionModule': {'briefSummary': 'The efficacy of two forms of psychotherapy with panic disordered patients, a cognitive-behavioral and a psychodynamic one, are compared under two different, randomized conditions: randomization or self-selection. The basic hypotheses are that the efficacy of both treatments is higher and that the efficacy difference is smaller under self-selection than randomized conditions.', 'detailedDescription': 'After thorough assessment persons with a panic disorder diagnosis are randomly assigned to three arms: one randomization, one self-selection, and one a low-contact waiting list one. In the randomization arm (R) 95 persons are randomly assigned to Panic Control Treatment (PCT) or Panic-Focused Psychodynamic Psychotherapy (PFPP); in the self-selection arm (SS) 95 persons are offered, after adequate information, to choose which of the two they prefer. Twenty-six persons are initially randomized to a three-month waiting list (with sparse contact over telephone), after which they will be re-randomized, either to further randomization (to PCT or PFPP) or to self-selection. The four groups (R/PCT; R/PFPP; SS/PCT; SS/PFPP) will be compared on the basis of intake and repeated outcome/follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A Diagnostic and Statistical Manual (DSM-V) diagnosis of Panic Disorder, with or without Agoraphobia\n* Age between 18 and 60\n* Willingness to stop other on-going psychotherapy treatments and to refrain from nonstudy treatments during follow up\n* Ability to complete the active treatment phase (not including follow-ups) within 16 weeks\n\nExclusion Criteria:\n\n* Active substance dependence (6 months remission necessary)\n* Current psychosis, delusions, mania, or active addiction\n* Acute suicidality\n* A history and clinical presentation of at least one clinically-significant medical condition if, due to their cognitive or physical impairments, they are unable to fully participate in the psychotherapy treatments being offered\n* Active involvement in a legal dispute related to their mental health issues\n* Three or more unexcused absences'}, 'identificationModule': {'nctId': 'NCT01606592', 'briefTitle': 'Psychotherapy Outcome and Self-selection Effects in Panic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Phase 2/3 Study of Panic Control Treatment vs Panic-Focussed Psychodynamic Psychotherapy Under Randomized and Self-Selection Conditions', 'orgStudyIdInfo': {'id': 'POSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized Panic Control Treatment', 'description': 'Patients who have been randomized to the randomization condition are assigned to PCT', 'interventionNames': ['Behavioral: Panic Control Treatment (PCT)']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Panic-Focused Psychodynamic Psychotherapy', 'description': 'Patients who have been randomized to the randomization condition are assigned to PFPP', 'interventionNames': ['Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)']}, {'type': 'EXPERIMENTAL', 'label': 'Self-selected Panic Control Treatment', 'description': 'Patients who have been randomized to the self-selection condition choose PCT', 'interventionNames': ['Behavioral: Panic Control Treatment (PCT)']}, {'type': 'EXPERIMENTAL', 'label': 'Self-selected Panic-Focussed Psychodynamic Psychotherapy', 'description': 'Patients who have been randomized to the self-selection condition choose PFPP', 'interventionNames': ['Behavioral: Panic-Focused Psychodynamic Psychotherapy (PFPP)']}, {'type': 'EXPERIMENTAL', 'label': 'Waiting-list', 'description': 'Patients who have been randomized to the waiting-list are offered sparse contact over telephone for 12 weeks and are then re-randomized to one of the other four arms', 'interventionNames': ['Other: Waiting-list']}], 'interventions': [{'name': 'Panic Control Treatment (PCT)', 'type': 'BEHAVIORAL', 'description': 'Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.', 'armGroupLabels': ['Randomized Panic Control Treatment', 'Self-selected Panic Control Treatment']}, {'name': 'Panic-Focused Psychodynamic Psychotherapy (PFPP)', 'type': 'BEHAVIORAL', 'description': 'Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.', 'armGroupLabels': ['Randomized Panic-Focused Psychodynamic Psychotherapy', 'Self-selected Panic-Focussed Psychodynamic Psychotherapy']}, {'name': 'Waiting-list', 'type': 'OTHER', 'description': 'Sparse telephone contact during 12 weeks, then re-randomization', 'armGroupLabels': ['Waiting-list']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-221 00', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Rolf Sandell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}