Understanding the Role of Sleep in Complicated Grief

• Sponsor: NYU Langone Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03533465
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• 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).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: Jul 2, 2018
• Actual Primary Completion Date: Mar 25, 2019
• Actual Study Completion Date: Mar 25, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Clinical Global Impression Scales [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Naomi Simon, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03533465
• Other Study ID Numbers: 18-00003
• First Posted: May 23, 2018
• Last Update Posted: Mar 4, 2022
• Last Verified: Mar 1, 2022

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

Study Results

No Results Posted as of Mar 4, 2022