Cognitive Behavioral Therapy for Complicated Grief (CG-CBT)

This study has been completed.
Sponsor:
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
  Purpose

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 Intervention
Grief
Behavioral: Cognitive Behavioral Therapy for Complicated Grief
Other: no treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: May 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Other: no treatment
Four months waiting period with monthly no-treatment safety checks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age complicated grief diagnosis

Exclusion Criteria:

  • acute suicidality
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433653

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

No publications provided

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
Study First Received: July 18, 2011
Last Updated: September 13, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 20, 2014