A Study of Medication With or Without Psychotherapy for Complicated Grief (HEAL)
This study is currently recruiting participants.
Verified December 2012 by New York State Psychiatric Institute
Sponsor:
New York State Psychiatric Institute
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: December 18, 2012
Last verified: December 2012
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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:
- Change from baseline in 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. 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.
| Estimated Enrollment: | 480 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (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 60 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: Celexa or Sugar pill
|
|
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 60 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: Celexa or Sugar pill
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 RCT 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179568
Locations
| United States, California | |
| VASDHS / University of California San Diego | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: Ilanit T Young, PhD 858-552-7598 ityoung@vapop.ucsd.edu | |
| Principal Investigator: Sidney Zisook, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Riva Shah 617-726-4585 rmshah@partners.org | |
| Principal Investigator: Naomi Simon, MD | |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Natalia A Skritskaya, PhD 212-851-2107 sw-cgte@columbia.edu | |
| Contact: Bevin Campbell, PsyD 212-543-5177 sw-cgte@columbia.edu | |
| Principal Investigator: Katherine Shear, MD | |
| Sub-Investigator: Naihua Duan, PhD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Mary McShea 412-246-6006 McSheaMC@upmc.edu | |
| Contact: Jacqueline Stack, MSN, APRN 412-246-6006 stackja@upmc.edu | |
| Principal Investigator: Charles F Reynolds, MD | |
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: | December 18, 2012 |
| 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 Serotonin Uptake Inhibitors Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013