Cognitive Behavioral Therapy for Complicated Grief

NCT01433653 | Completed DMC

• 1 other identifier: LMU-KlinPsy001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Grief

Keywords

Comorbid; Complicated

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (2)

CG-CBT

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy for Complicated Grief

wait list control

NO INTERVENTION

Interventions

Cognitive Behavioral Therapy for Complicated Grief BEHAVIORAL

Manualized CBT with 25 sessions, once a week. Key elements are exposition and cognitive restructuring.

CG-CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age complicated grief diagnosis

You may not qualify if:

• acute suicidality

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

LMU

Munich, D-80802, Germany

Location

Related Publications (2)

• Rosner R, Pfoh G, Kotoucova 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.

  PMID: 25082115 RESULT

• Rosner R, Bartl H, Pfoh G, Kotoucova 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.

  PMID: 26001670 RESULT

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rita Rosner, Dr. phil.

  LMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Rita Rosner

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: September 14, 2011
• Study Start: May 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

DE (1)