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Understanding the Role of Sleep in Complicated Grief

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ClinicalTrials.gov Identifier: NCT03533465
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE May 23, 2018
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE July 2, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
Clinical Global Impression Scales [ Time Frame: 16 Weeks ]
Measure of Clinical Improvement and Severity of illness on a scale of 1-7; 1 being "Very Much Improved"; 7 being Very Much Worse
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03533465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Understanding the Role of Sleep in Complicated Grief
Official Title  ICMJE Understanding the Role of Sleep in Complicated Grief: A Pilot Study
Brief Summary

The purpose of this study is to learn more about the causes of Complicated Grief (CG) in those who experience the loss of a loved one. This study aims at learning more about the sleep patterns and emotions in participants with CG as compared to those who have lost a loved one but do not have CG.

This study will consist of two aims:

Aim 1: Approximately 10 complicated grief (CG) patients and 10 controls (without a current psychiatric diagnosis) will complete a 3-day home polysomnography (PSG) sleep assessment in addition to several self-report sleep and psychiatric measures.

Aim 2: Approximately 10 CG patients (subsample from Aim 1) will complete 16 weekly sessions of complicated grief therapy (CGT) in addition to completion of repeated PSG assessments and self-report sleep and psychiatric measures.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
The first aim of this study will involve a comparison of baseline psychiatric symptoms and subjective and objective measures of sleep, with specific attention to REM, in adults with CG compared to 25 healthy controls. 10 of these adults with CG who complete AIM 1 will participate in Complicated Grief Treatment (CGT).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep
  • Grief
Intervention  ICMJE Behavioral: Complicated Grief Therapy (CGT)
CGT is an evidence based 16 session targeted grief therapy delivered in individual one hour weekly sessions. Treatment will end at 16 sessions (offered over the course of 20 weeks)
Study Arms  ICMJE Experimental: Complicated Grief Treatment (CGT)
10 adults with CG who successfully completed Aim 1 and will also participate in open complicated grief treatment (CGT), during which they will complete additional subjective and objective sleep assessments.
Intervention: Behavioral: Complicated Grief Therapy (CGT)
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Bereaved due to death of a loved one >= 6 months prior (for both CG and control groups)
  • For CG participants: grief is primary psychiatric problem with ICG >= 30 (threshold symptoms; for CG group only). Controls will be free of current psychiatric disorders with the exception of specific phobia.
  • Normal or corrected vision

Exclusion Criteria:

  • Psychiatric or sleep medications in the past 4 weeks (past 6 weeks for fluoxetine)
  • Concurrent grief or exposure based therapy
  • Lifetime bipolar, psychosis, significant neurological disorders
  • Past 6 months of alcohol/substance use disorder
  • Unstable medical illness
  • Serious safety concerns of suicide or homicide
  • Pregnant or nursing
  • Overnight shift work
  • > 4 caffeinated or > 11 alcoholic beverages per week
  • Screening reveals OSA defined as an apnea hypopnea index with 4% desaturation (AHI4%) ≥15 or an AHI4% ≥ with an Epworth >10
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Carly Miron 646-754-7035 Carly.Miron@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03533465
Other Study ID Numbers  ICMJE 18-00003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Naomi Simon, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date June 2019

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