Bereavement Clinical Trial
— HEALOfficial title:
Optimizing Treatment for Complicated Grief (Healing Emotions After Loss:HEAL)
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | American Foundation for Suicide Prevention, National Institute of Mental Health (NIMH) |
United States,
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
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 |
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