This resubmission application is for competitive renewals of our prior grant (MH060783) in which we established the efficacy of a targeted complicated grief treatment (CGT). The current application is to conduct a multicenter study to take the next steps needed to optimize treatment for individuals suffering from complicated grief, and responds to PA-07-092 inviting grant applications for collaborative studies of mental disorders in adults. Complicated grief (CG) is a debilitating condition that is estimated to affect millions of people in the United States alone. Our prior study was the first RCT to address this condition. Participants in our 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 have 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 escitalopram (ESC) efficacy. We plan to enroll 440 people with a primary diagnosis of Complicated Grief over 4.5 years, and to randomly assign them to receive 16 weeks of treatment with ESC, PBO, ESC + CGT or PBO + CGT.
Specific aims are to compare 1) ESC v PBO, 2) ESC + CGT v PBO + CGT and 3) CGT + ESC v ESC on measures of responder status and on improvement in CG symptoms, depression, anxiety, functional impairment, sleep and suicidality. We will explore mediator and moderator hypotheses to answer questions about how these treatments work and who might benefit most from each approach. Answers to these questions have important public health significance.

Public Health Relevance

Complicated grief (CG) is an impairing condition that is estimated to occur in approximately 10% of bereaved people. CG causes significant distress and impairment and also puts people at risk for serious negative health consequences, including cancer and cardiovascular disease. Very little is known about how to treat this condition. Results of this study will provide critical new information for patients and clinicians regarding medication efficacy, and will provide data to inform clinicians about how best to treat individuals suffering from complicated grief.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH085308-04
Application #
8255605
Study Section
Special Emphasis Panel (ZMH1-ERB-F (02))
Program Officer
Rudorfer, Matthew V
Project Start
2009-08-15
Project End
2014-02-28
Budget Start
2012-03-01
Budget End
2013-02-28
Support Year
4
Fiscal Year
2012
Total Cost
$406,440
Indirect Cost
$270,314
Name
Massachusetts General Hospital
Department
Type
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02199
Hall, Charles A; Reynolds 3rd, Charles F; Butters, Meryl et al. (2014) Cognitive functioning in complicated grief. J Psychiatr Res 58:20-5
Robinaugh, Donald J; McNally, Richard J; LeBlanc, Nicole J et al. (2014) Anxiety sensitivity in bereaved adults with and without complicated grief. J Nerv Ment Dis 202:620-2
Simon, Naomi M (2013) Treating complicated grief. JAMA 310:416-23
Shear, M Katherine; Simon, Naomi; Wall, Melanie et al. (2011) Complicated grief and related bereavement issues for DSM-5. Depress Anxiety 28:103-17
Sung, Sharon C; Dryman, M Taylor; Marks, Elizabeth et al. (2011) Complicated grief among individuals with major depression: prevalence, comorbidity, and associated features. J Affect Disord 134:453-8
Zisook, Sidney; Reynolds 3rd, Charles F; Pies, Ronald et al. (2010) Bereavement, complicated grief, and DSM, part 1: depression. J Clin Psychiatry 71:955-6