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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 : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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.


Condition or disease Intervention/treatment Phase
Sleep Grief Behavioral: Complicated Grief Therapy (CGT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Official Title: Understanding the Role of Sleep in Complicated Grief: A Pilot Study
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Arm Intervention/treatment
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.
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)




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533465


Contacts
Contact: Julia Spandorfer 646-754-4895 Julia.Spandorfer@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Julia Spandorfer    646-754-4895    Julia.Spandorfer@nyumc.org   
Principal Investigator: Naomi Simon, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Naomi Simon, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03533465     History of Changes
Other Study ID Numbers: 18-00003
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No