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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179568
First Posted: August 11, 2010
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: September 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Complicated Grief
Bereavement
Interventions: Drug: Citalopram
Behavioral: Complicated Grief Treatment
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Bereaved individuals age 18-95 were recruited between March 2010 and September 2014 using professional and public outreach, print, broadcast and internet media. Referrals were made by health care professionals, bereavement counselors and patients or family members.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Citalopram

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

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Placebo (Sugar Pill)

Inactive medication. It is combined with grief-focused clinical management.

Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

CGT With Citalopram

The targeted psychotherapy for complicated grief combined with SSRI medication.

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.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

CGT With Placebo

The targeted psychotherapy for complicated grief combined with inactive medication.

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.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.


Participant Flow:   Overall Study
    Citalopram   Placebo (Sugar Pill)   CGT With Citalopram   CGT With Placebo
STARTED   101   99   99   96 
Completed Week 12 Assessment   69   69   76   75 
COMPLETED [1]   73   61   76   76 
NOT COMPLETED   28   38   23   20 
[1] Week 20 assessment



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Citalopram

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

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Placebo (Sugar Pill)

Inactive medication. It is combined with grief-focused clinical management.

Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

CGT With Citalopram

The targeted psychotherapy for complicated grief combined with SSRI medication.

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.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

CGT With Placebo

The targeted psychotherapy for complicated grief combined with inactive medication.

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.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.

Total Total of all reporting groups

Baseline Measures
   Citalopram   Placebo (Sugar Pill)   CGT With Citalopram   CGT With Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   99   99   96   395 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.4  (13.1)   53.9  (13.8)   52.1  (15.3)   53.5  (16.0)   53.0  (14.5) 
Gender 
[Units: Participants]
Count of Participants
         
Female      82  81.2%      69  69.7%      78  78.8%      79  82.3%      308  78.0% 
Male      19  18.8%      30  30.3%      21  21.2%      17  17.7%      87  22.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      10   9.9%      7   7.1%      8   8.1%      20  20.8%      45  11.4% 
Not Hispanic or Latino      91  90.1%      92  92.9%      91  91.9%      76  79.2%      350  88.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
         
While   85   80   81   79   325 
Black   10   8   11   10   39 
Others   6   11   7   7   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale   [ Time Frame: Weeks 12 and 20 ]

2.  Secondary:   Change From Baseline in Inventory of Complicated Grief (ICG)   [ Time Frame: Baseline and week 12 ]

3.  Secondary:   Change From Baseline in Inventory of Complicated Grief (ICG)   [ Time Frame: Baseline and week 20 ]

4.  Secondary:   Change From Baseline in Work and Social Adjustment Scale (WSAS)   [ Time Frame: Baseline and week 12 ]

5.  Secondary:   Change From Baseline in Work and Social Adjustment Scale (WSAS)   [ Time Frame: Baseline and week 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Two limitations of note: 1) FDA lowered the maximum safe dose of study medication (citalopram) after the study started; 2) our recruitment rate was 90% of target, while the assessment drop-out rate was over double what we expected.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: M. Katherine Shear, MD
Organization: Columbia School of Social Work
phone: 212-851-2176
e-mail: ks2394@columbia.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01179568     History of Changes
Other Study ID Numbers: 5971
R01MH060783 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2010
First Posted: August 11, 2010
Results First Submitted: September 6, 2016
Results First Posted: January 24, 2017
Last Update Posted: January 24, 2017