A Study of Medication With or Without Psychotherapy for Complicated Grief

Bereavement Clinical Trial

— HEAL  

Official title:

Optimizing Treatment for Complicated Grief (Healing Emotions After Loss:HEAL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179568
• Other study ID #: 5971
• Secondary ID: R01MH060783
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2010
• Last updated: August 27, 2015
• Start date: March 2010
• Est. completion date: July 2015

Study information

• Verified date: February 2015
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The major goal of this 4-site, double blind, placebo-controlled intervention trial is to assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief Therapy) to treat the symptoms of complicated grief.

Description:

Complicated grief (CG) is a debilitating condition that is estimated to affect millions of people in the United States alone. We conducted the first randomized controlled study to address this condition (MH60783) and confirmed efficacy of a targeted psychotherapy, complicated grief treatment (CGT). Participants in our prior study continued stable antidepressant medication while receiving CGT or Interpersonal Psychotherapy (IPT). Individuals taking antidepressants had better outcome in both treatments, though CGT was superior to IPT when administered with (60% responders v. 40%) or without (42% v.19%) antidepressants. Studies of antidepressant medication alone have shown mixed results with SSRIs appearing to be promising. However, there has been no randomized controlled study of SSRIs for CG. Determining the efficacy of SSRI treatment for CG, when administered with and without CGT, is of great public health importance.

We assembled 4 groups of investigators with strong track records in bereavement research and extensive experience with intervention studies and multicenter projects, to conduct a study of citalopram (CIT) efficacy. We plan to enroll participants with a primary diagnosis of Complicated Grief and randomly assign them (n=480; 50 at Columbia) to receive treatment with CIT, Placebo (PBO), CIT + CGT or PBO + CGT over a period of approximately 16 weeks. We want to determine whether citalopram shows a better response than placebo, when administered either with or without CGT. We will also address the question of whether CIT performs as well when administered alone as it does when administered with CGT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Diagnosed with Complicated Grief and this is the patient's most important (primary) problem

• Ability to give informed consent

• Fluent in English

• Willingness to have sessions audiotaped

• Willingness to undergo random assignment

Exclusion Criteria:

• Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse, Bipolar Disorder, current manic episode, Dementia

• Pregnant or lactating women and women of childbearing potential not using medically accepted forms of contraception

• Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis

• Prior intolerance of citalopram

• Pending or active disability claim or lawsuit related to the death

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bereavement
• Complicated Grief

Intervention

Drug:
• Citalopram
16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.

Behavioral:
• Complicated Grief Treatment
Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Other:
• Placebo
16 weeks of daily inactive medication. It will be administered in a double-blind fashion.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	New York State Psychiatric Institute	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	VASDHS / University of California San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	American Foundation for Suicide Prevention, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Jacobs SC, Nelson JC, Zisook S. Treating depressions of bereavement with antidepressants. A pilot study. Psychiatr Clin North Am. 1987 Sep;10(3):501-10. — View Citation

Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 Aug;20(8):637-48. — View Citation

Shear K, Frank E, Houck PR, Reynolds CF 3rd. Treatment of complicated grief: a randomized controlled trial. JAMA. 2005 Jun 1;293(21):2601-8. — View Citation

Shear MK. Clinical practice. Complicated grief. N Engl J Med. 2015 Jan 8;372(2):153-60. doi: 10.1056/NEJMcp1315618. Review. — View Citation

Simon NM, Thompson EH, Pollack MH, Shear MK. Complicated grief: a case series using escitalopram. Am J Psychiatry. 2007 Nov;164(11):1760-1. — View Citation

Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder status based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale	Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief will be used. Response is defined as a score of 1(very much improved), or 2 (much improved) on the scale. The rating will be done by the Independent Evaluator.	Week 40	No
Secondary	Change from baseline in Inventory of Complicated Grief (ICG)	The 19-item self-report instrument that assesses symptoms of CG. This scale has been utilized previously in treatment studies of CG. Additional times points will include weeks 4, 8, 12, 16, and 20.	Week 40	No
Secondary	Change from baseline in Work and Social Adjustment Scale (WSAS)	The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional times points will include weeks 4, 8, 12, 16, and 20.	Week 40	No
Secondary	Change from baseline in Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale	Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief will be used. The rating will be done by Independent Evaluator.	Weeks 4, 8, 12, 16, and 20.	No

External Links

•   Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, Boston
•   Complicated Grief Program at Columbia University, New York
•   Complicated Grief Research Group at Massachusetts General Hospital in Boston
•   Complicated Grief Research Group at University of California in San Diego