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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
History of Changes
  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:

MedlinePlus related topics: Bereavement
U.S. FDA Resources

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
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 May 16, 2013