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

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ClinicalTrials.gov Identifier: NCT01179568
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
New York State Psychiatric Institute

Tracking Information
First Submitted Date  ICMJE July 14, 2010
First Posted Date  ICMJE August 11, 2010
Results First Submitted Date  ICMJE September 6, 2016
Results First Posted Date  ICMJE January 24, 2017
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Weeks 12 and 20 ]
Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
Change from baseline in Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Baseline; Week 40 ]
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.
Change History Complete list of historical versions of study NCT01179568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
  • Change From Baseline in Inventory of Complicated Grief (ICG) [ Time Frame: Baseline and week 12 ]
    The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.
  • Change From Baseline in Inventory of Complicated Grief (ICG) [ Time Frame: Baseline and week 20 ]
    The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.
  • Change From Baseline in Work and Social Adjustment Scale (WSAS) [ Time Frame: Baseline and week 12 ]
    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 time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.
  • Change From Baseline in Work and Social Adjustment Scale (WSAS) [ Time Frame: Baseline and week 20 ]
    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 time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
  • Inventory of Complicated Grief (ICG) [ Time Frame: Weeks 4, 8, 12, 16, 20 and 40 ]
    The 19-item self-report instrument that assesses symptoms of CG. This scale has been utilized previously in treatment studies of CG.
  • Work and Social Adjustment Scale (WSAS) [ Time Frame: Weeks 4, 8, 12, 16, 20 and 40 ]
    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.
  • Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Weeks 4, 8, 12, 16, 20 and 40 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Medication With or Without Psychotherapy for Complicated Grief
Official Title  ICMJE Optimizing Treatment for Complicated Grief (Healing Emotions After Loss:HEAL)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Complicated Grief
  • Bereavement
Intervention  ICMJE
  • 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
  • Other: Placebo
    16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
    Other Name: Sugar pill
Study Arms  ICMJE
  • Active Comparator: CGT with Citalopram
    Targeted psychotherapy for complicated grief will be combined with SSRI medication.
    Interventions:
    • Drug: Citalopram
    • Behavioral: Complicated Grief Treatment
  • Active Comparator: Citalopram
    Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It will be combined with grief-focused clinical management.
    Intervention: Drug: Citalopram
  • Placebo Comparator: Placebo (Sugar pill)
    Inactive medication. It will be combined with grief-focused clinical management.
    Intervention: Other: Placebo
  • Active Comparator: CGT with Placebo
    The targeted psychotherapy for complicated grief will be combined with inactive medication.
    Interventions:
    • Behavioral: Complicated Grief Treatment
    • Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2015)
395
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2010)
480
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01179568
Other Study ID Numbers  ICMJE 5971
R01MH060783 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • American Foundation for Suicide Prevention
Investigators  ICMJE
Principal Investigator: Katherine Shear, MD Columbia University
PRS Account New York State Psychiatric Institute
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP