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Understanding the Role of Sleep in Complicated Grief

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03533465
Enrollment
5
Registered
2018-05-23
Start date
2018-07-02
Completion date
2019-03-25
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grief, Sleep

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.

Interventions

BEHAVIORALComplicated 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)

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Global Impression Scales16 WeeksMeasure of Clinical Improvement and Severity of illness on a scale of 1-7; 1 being Very Much Improved; 7 being Very Much Worse

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026