Cognitive Behavioral Therapy for Complicated Grief (CG-CBT)
This study has been completed.
Sponsor:
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Rita Rosner, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01433653
First received: July 18, 2011
Last updated: September 13, 2011
Last verified: September 2011
| Tracking Information | |||||
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| First Received Date ICMJE | July 18, 2011 | ||||
| Last Updated Date | September 13, 2011 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PG-13 (Prolonged Grief Interview - 13 Item version) [ Time Frame: Change between intake (t1) and end of treatment (t2) in complicated grief severity within 5 months. t1= before treatment or wait list begins, t2 = 4 months after t1 (end of treatment, end of waitlist), t3 = follow-up (1.5 years after t2) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01433653 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive Behavioral Therapy for Complicated Grief | ||||
| Official Title ICMJE | Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief | ||||
| Brief Summary | The purpose of this study is to determine whether cognitive behavioral therapy (CG-CBT) for complicated grief is superior to wait list condition in patients with comorbid complicated grief. To evaluate the effect pre-post changes for patients in the CG-CBT-group will be compared to changes in the wait list group. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Grief | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 51 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01433653 | ||||
| Other Study ID Numbers ICMJE | LMU-KlinPsy001 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Rita Rosner, Ludwig-Maximilians - University of Munich | ||||
| Study Sponsor ICMJE | Ludwig-Maximilians - University of Munich | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Ludwig-Maximilians - University of Munich | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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