A Study of Medication With or Without Psychotherapy for Complicated Grief
Condition: Complicated Grief; Bereavement
Study type: Interventional
Phase: Phase 2

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.
    

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 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.
    

Intervention name(s): Citalopram; Complicated Grief Treatment; Placebo
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): 16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.; 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.; 16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Other intervention name(s): Celexa; CGT; Sugar pill
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Grief; Bereavement; Psychotherapy; Medication; Treatment study