Cognitive Behavioral Therapy for Complicated Grief

Grief Clinical Trial

— CG-CBT  

Official title:

Randomized Controlled Clinical Trial of Cognitive Behavioral Therapy for Complicated Grief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433653
• Other study ID #: LMU-KlinPsy001
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: June 8, 2015
• Start date: May 2005
• Est. completion date: February 2011

Study information

• Verified date: June 2015
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age complicated grief diagnosis

Exclusion Criteria:

• acute suicidality

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grief

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Complicated Grief
Manualized CBT with 25 sessions, once a week. Key elements are exposition and cognitive restructuring.

Locations

Country	Name	City	State
Germany	LMU	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Rosner R, Bartl H, Pfoh G, Kotoucová M, Hagl M. Efficacy of an integrative CBT for prolonged grief disorder: A long-term follow-up. J Affect Disord. 2015 Sep 1;183:106-12. doi: 10.1016/j.jad.2015.04.051. Epub 2015 May 8. — View Citation

Rosner R, Pfoh G, Kotoucová M, Hagl M. Efficacy of an outpatient treatment for prolonged grief disorder: a randomized controlled clinical trial. J Affect Disord. 2014;167:56-63. doi: 10.1016/j.jad.2014.05.035. Epub 2014 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PG-13 (Prolonged Grief Interview - 13 Item version)		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)	No
Secondary	Symptom Checklist 90 revised (SCL-90R; Subscale General Symptom Index, GSI)		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)	No
Secondary	Comorbid Diagnoses by DIA-X-Interview		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)	No