Understanding the Role of Sleep in Complicated Grief

Not Applicable

Terminated

• Conditions: Sleep; Grief
• Interventions: Behavioral: Complicated Grief Therapy (CGT)

• Registration Number: NCT03533465
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-23
• Study Start: 2018-07-02
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-25
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Complicated Grief Treatment (CGT)	Complicated Grief Therapy (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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States