A Study of Medication With or Without Psychotherapy for Complicated Grief - Full Text View

Sponsor:	New York State Psychiatric Institute
Collaborators:	National Institute of Mental Health (NIMH) American Foundation for Suicide Prevention
Information provided by (Responsible Party):	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT01179568

Purpose

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.

Condition	Intervention	Phase
Complicated Grief Bereavement	Drug: Citalopram Behavioral: Complicated Grief Treatment Other: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Optimizing Treatment for Complicated Grief (Healing Emotions After Loss:HEAL)

Resource links provided by NLM:

MedlinePlus related topics: Bereavement

Drug Information available for: Serotonin Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:

Change from baseline in Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
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 the Independent Evaluator.

Secondary Outcome Measures:

Change from baseline in Inventory of Complicated Grief (ICG) [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
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.
Change from baseline in Work and Social Adjustment Scale (WSAS) [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
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.
Change from baseline in Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Weeks 4, 8, 12, 16, and 20. ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	480
Study Start Date:	March 2010
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: CGT with Citalopram Targeted psychotherapy for complicated grief will be combined with SSRI medication.	Drug: Citalopram 16 weeks of medication provided flexibly up to 60 mg/day Medication will be administered in a double-blind fashion. Other Name: Celexa 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 Name: Celexa or Sugar pill
Active Comparator: Citalopram Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.	Drug: Citalopram 16 weeks of medication provided flexibly up to 60 mg/day Medication will be administered in a double-blind fashion. Other Name: Celexa
Placebo Comparator: Placebo (Sugar pill) Inactive medication. It will be combined with grief-focused clinical management.	Other: Placebo 16 weeks of daily inactive medication. It will be administered in a double-blind fashion. Other Name: Sugar pill
Active Comparator: CGT with Placebo The targeted psychotherapy for complicated grief will be combined with inactive medication.	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 Name: Celexa or Sugar pill Other: Placebo 16 weeks of daily inactive medication. It will be administered in a double-blind fashion. Other Name: Sugar pill

Detailed 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 RCT 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.

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179568

Locations

United States, California
VASDHS / University of California San Diego	Recruiting
San Diego, California, United States, 92161
Contact: Ilanit T Young, PhD 858-552-7598 ityoung@vapop.ucsd.edu
Contact: Jennifer Madowitz, BA 858-552-8585 ext 5583 jmadowitz@vapop.ucsd.edu
Principal Investigator: Sidney Zisook, MD
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nicole J Leblanc 617-726-4585 njleblanc@partners.org
Principal Investigator: Naomi Simon, MD
United States, New York
New York State Psychiatric Institute	Recruiting
New York, New York, United States, 10032
Contact: Natalia A Skritskaya, PhD 212-851-2107 sw-cgte@columbia.edu
Contact: Bevin Campbell, PsyD 212-543-5177 sw-cgte@columbia.edu
Principal Investigator: Katherine Shear, MD
Sub-Investigator: Naihua Duan, PhD
United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jill Houle 412-246-6006 houleja@upmc.edu
Contact: Jacqueline Stack, MSN, APRN 412-246-6006 stackja@upmc.edu
Principal Investigator: Charles F Reynolds, MD

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute of Mental Health (NIMH)

American Foundation for Suicide Prevention

Investigators

Principal Investigator:

Katherine Shear, MD

Columbia University

More Information

Additional Information:

Complicated Grief Research Group at University of California in San Diego This link exits the ClinicalTrials.gov site

Complicated Grief Research Group at Massachusetts General Hospital in Boston This link exits the ClinicalTrials.gov site

Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, Boston This link exits the ClinicalTrials.gov site

Complicated Grief Research Group at University of Pittsburgh Medical Center This link exits the ClinicalTrials.gov site

Complicated Grief Program at Columbia University, New York This link exits the ClinicalTrials.gov site

Publications:

Simon NM, Thompson EH, Pollack MH, Shear MK. Complicated grief: a case series using escitalopram. Am J Psychiatry. 2007 Nov;164(11):1760-1. No abstract available.

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.

Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 Aug;20(8):637-48. No abstract available.

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.

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.

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT01179568 History of Changes
Other Study ID Numbers:	5971, R01MH060783
Study First Received:	July 14, 2010
Last Updated:	March 8, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:

Grief
Bereavement
Psychotherapy
Medication
Treatment study

Additional relevant MeSH terms:

Citalopram
Serotonin Uptake Inhibitors
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 23, 2012