A Study of Medication With or Without Psychotherapy for Complicated Grief
NCT ID: NCT01179568
Last Updated: 2017-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
395 participants
INTERVENTIONAL
2010-03-31
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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CGT with Citalopram
Targeted psychotherapy for complicated grief will be combined with SSRI medication.
Citalopram
16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
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.
Citalopram
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.
Citalopram
16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
Placebo (Sugar pill)
Inactive medication. It will be combined with grief-focused clinical management.
Placebo
16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
CGT with Placebo
The targeted psychotherapy for complicated grief will be combined with inactive medication.
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.
Placebo
16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Interventions
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Citalopram
16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
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.
Placebo
16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to give informed consent
* Fluent in English
* Willingness to have sessions audiotaped
* Willingness to undergo random assignment
Exclusion Criteria
* 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
18 Years
95 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
American Foundation for Suicide Prevention
OTHER
New York State Psychiatric Institute
OTHER
Responsible Party
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Principal Investigators
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Katherine Shear, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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VASDHS / University of California San Diego
San Diego, California, 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
Countries
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References
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Simon NM, Thompson EH, Pollack MH, Shear MK. Complicated grief: a case series using escitalopram. Am J Psychiatry. 2007 Nov;164(11):1760-1. doi: 10.1176/appi.ajp.2007.07050800. 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. doi: 10.1001/jama.293.21.2601.
Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967 Aug;20(8):637-48. doi: 10.1016/0021-9681(67)90041-0. 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. doi: 10.1001/jama.290.12.1624.
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.
Shear MK. Clinical practice. Complicated grief. N Engl J Med. 2015 Jan 8;372(2):153-60. doi: 10.1056/NEJMcp1315618. No abstract available.
Calderon A, Irwin M, Simon NM, Shear MK, Mauro C, Zisook S, Reynolds CF 3rd, Malgaroli M. Depression is Associated with Treatment Response Trajectories in Adults with Prolonged Grief Disorder: A Machine Learning Analysis. medRxiv [Preprint]. 2024 Dec 12:2024.12.11.24318861. doi: 10.1101/2024.12.11.24318861.
Na PJ, Adhikari S, Szuhany KL, Chen AZ, Suzuki RR, Malgaroli M, Robinaugh DJ, Bui E, Mauro C, Skritskaya NA, Lebowitz BD, Zisook S, Reynolds CF 3rd, Shear MK, Simon NM. Posttraumatic Distress Symptoms and Their Response to Treatment in Adults With Prolonged Grief Disorder. J Clin Psychiatry. 2021 Apr 20;82(3):20m13576. doi: 10.4088/JCP.20m13576.
Zisook S, Shear MK, Reynolds CF, Simon NM, Mauro C, Skritskaya NA, Lebowitz B, Wang Y, Tal I, Glorioso D, Wetherell JL, Iglewicz A, Robinaugh D, Qiu X. Treatment of Complicated Grief in Survivors of Suicide Loss: A HEAL Report. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11592. doi: 10.4088/JCP.17m11592.
Shear MK, Reynolds CF 3rd, Simon NM, Zisook S, Wang Y, Mauro C, Duan N, Lebowitz B, Skritskaya N. Optimizing Treatment of Complicated Grief: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Jul 1;73(7):685-94. doi: 10.1001/jamapsychiatry.2016.0892.
Related Links
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Complicated Grief Research Group at University of Pittsburgh Medical Center
Complicated Grief Program at Columbia University, New York
Other Identifiers
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5971
Identifier Type: -
Identifier Source: org_study_id
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