Understanding the Role of Sleep in Complicated Grief

Understanding the Role of Sleep in Complicated Grief: A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Sleep; Grief
• Intervention / Treatment: Behavioral: Complicated Grief Therapy (CGT)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression Scales	Measure of Clinical Improvement and Severity of illness on a scale of 1-7; 1 being "Very Much Improved"; 7 being Very Much Worse	16 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2018
• Primary Completion (ACTUAL): March 25, 2019
• Study Completion (ACTUAL): March 25, 2019

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (ACTUAL): May 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 18-00003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No