Understanding the Role of Sleep in Complicated Grief

NYU Langone Health

Status: Terminated

Conditions: Grief; Sleep

Treatments: Behavioral: Complicated Grief Therapy (CGT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03533465

18-00003

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Complicated Grief Treatment (CGT)

Experimental group

Description:

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.

Treatment:

Behavioral: Complicated Grief Therapy (CGT)