A Study of Medication With or Without Psychotherapy for Complicated Grief (HEAL)

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Bereavement; Complicated Grief

Treatments: Behavioral: Complicated Grief Treatment; Drug: Citalopram; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01179568

R01MH060783 (U.S. NIH Grant/Contract)

5971

Details and patient eligibility

About

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.

Full 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.

Enrollment: 395 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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395 participants in 4 patient groups, including a placebo group

CGT with Citalopram

Active Comparator group

Description:

Targeted psychotherapy for complicated grief will be combined with SSRI medication.

Treatment:

Drug: Citalopram

Behavioral: Complicated Grief Treatment

Citalopram

Active Comparator group

Description:

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.

Treatment:

Drug: Citalopram

Placebo (Sugar pill)

Placebo Comparator group

Description:

Inactive medication. It will be combined with grief-focused clinical management.

Treatment:

Other: Placebo

CGT with Placebo

Active Comparator group

Description:

The targeted psychotherapy for complicated grief will be combined with inactive medication.

Treatment:

Other: Placebo

Behavioral: Complicated Grief Treatment