Understanding the Role of Sleep in Complicated Grief

NCT ID: NCT03533465

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2019-03-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Complicated Grief Therapy (CGT)

Intervention Type: 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)

Interventions

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Simon, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

18-00003

Identifier Type: -

Identifier Source: org_study_id