Understanding the Role of Sleep in Complicated Grief

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03533465
• Other study ID #: 18-00003
• Status: Terminated
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: March 25, 2019

Study information

• Verified date: March 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Grief
• Sleep

Intervention

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)

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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