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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01179568
First received: July 14, 2010
Last updated: March 20, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Complicated Grief
Bereavement
Drug: Citalopram
Behavioral: Complicated Grief Treatment
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Treatment for Complicated Grief (Healing Emotions After Loss:HEAL)

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Responder status based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief will be used. Response is defined as a score of 1(very much improved), or 2 (much improved) on the scale. The rating will be done by the Independent Evaluator.


Secondary Outcome Measures:
  • Change from baseline in Inventory of Complicated Grief (ICG) [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    The 19-item self-report instrument that assesses symptoms of CG. This scale has been utilized previously in treatment studies of CG. Additional times points will include weeks 4, 8, 12, 16, and 20.

  • Change from baseline in Work and Social Adjustment Scale (WSAS) [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional times points will include weeks 4, 8, 12, 16, and 20.

  • Change from baseline in Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Weeks 4, 8, 12, 16, and 20. ] [ Designated as safety issue: No ]
    Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief will be used. The rating will be done by Independent Evaluator.


Enrollment: 395
Study Start Date: March 2010
Estimated Study Completion Date: July 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CGT with Citalopram
Targeted psychotherapy for complicated grief will be combined with SSRI medication.
Drug: Citalopram
16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
Other Name: Celexa
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 Name: CGT
Active Comparator: Citalopram
Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.
Drug: Citalopram
16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
Other Name: Celexa
Placebo Comparator: Placebo (Sugar pill)
Inactive medication. It will be combined with grief-focused clinical management.
Other: Placebo
16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Other Name: Sugar pill
Active Comparator: CGT with Placebo
The targeted psychotherapy for complicated grief will be combined with inactive medication.
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 Name: CGT
Other: Placebo
16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Other Name: Sugar pill

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179568

Locations
United States, California
VASDHS / University of California San Diego
San Diego, California, United States, 92161
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
New York State Psychiatric Institute
American Foundation for Suicide Prevention
Investigators
Principal Investigator: Katherine Shear, MD Columbia University
  More Information

Additional Information:
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01179568     History of Changes
Other Study ID Numbers: 5971, R01MH060783
Study First Received: July 14, 2010
Last Updated: March 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Grief
Bereavement
Psychotherapy
Medication
Treatment study

Additional relevant MeSH terms:
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2015