NCT01179568

A Study of Medication With or Without Psychotherapy for Complicated Grief

Optimizing Treatment for Complicated Grief (Healing Emotions After Loss:HEAL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complicated Grief
• Bereavement

Interventions

Type	Name	Description
DRUG	Citalopram	16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
BEHAVIORAL	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.
OTHER	Placebo	16 weeks of daily inactive medication. It will be administered in a double-blind fashion.

Timeline

• Start date: 2010-03-01
• Primary completion: 2015-02-01
• Completion: 2015-07-01
• First posted: 2010-08-11
• Last updated: 2017-01-24
• Results posted: 2017-01-24

Locations

4 sites across 1 country: United States