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Cognitive Behavioral Therapy for Complicated Grief (CG-CBT)

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ClinicalTrials.gov Identifier: NCT01433653
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Rita Rosner, Ludwig-Maximilians - University of Munich

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.

Condition or disease Intervention/treatment Phase
Grief Behavioral: Cognitive Behavioral Therapy for Complicated Grief Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief
Study Start Date : May 2005
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CG-CBT Behavioral: Cognitive Behavioral Therapy for Complicated Grief
Manualized CBT with 25 sessions, once a week. Key elements are exposition and cognitive restructuring.
No Intervention: wait list control



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Symptom Checklist 90 revised (SCL-90R; Subscale General Symptom Index, GSI) [ Time Frame: Change between intake (t1) and end of treatment (t2) in general distress symptoms 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) ]
  2. Comorbid Diagnoses by DIA-X-Interview [ Time Frame: Change between intake (t1) and end of treatment (t2) in number of comorbid psychiatric diagnoses 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age complicated grief diagnosis

Exclusion Criteria:

  • acute suicidality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433653


Locations
Germany
LMU
Munich, Germany, D-80802
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Rita Rosner, Dr. phil. LMU

Publications of Results:
Responsible Party: Rita Rosner, Prof. Dr. Rita Rosner, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01433653     History of Changes
Other Study ID Numbers: LMU-KlinPsy001
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: June 2015

Keywords provided by Rita Rosner, Ludwig-Maximilians - University of Munich:
Comorbid
Complicated