Clinical trial NCT01179568
Conditions: Complicated Grief Bereavement
Keywords: Grief Bereavement Psychotherapy Medication Treatment study
Sponsor: New York State Psychiatric Institute
Start date: 2010-03-01; Completion date: 2015-07-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief 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.

Arms: arm 1: Targeted psychotherapy for complicated grief will be combined with SSRI medication. arm 2: Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management. arm 3: Inactive medication. It will be combined with grief-focused clinical management. arm 4: The targeted psychotherapy for complicated grief will be combined with inactive medication.
Interventions: intervention 1: Citalopram intervention 2: Complicated Grief Treatment intervention 3: Placebo
Intervention descriptions: intervention 1: 16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion. intervention 2: 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. intervention 3: 16 weeks of daily inactive medication. It will be administered in a double-blind fashion.

Protocol documents: