Understanding the Role of Sleep in Complicated Grief

NCT03533465 | Terminated

• 1 other identifier: 18-00003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Grief

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Complicated Grief Treatment (CGT)

EXPERIMENTAL

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)

Interventions

Complicated Grief Therapy (CGT) BEHAVIORAL

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)

Complicated Grief Treatment (CGT)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• Naomi Simon, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 23, 2018
• Study Start: July 2, 2018
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

US (1)