TerminatedNot Applicable

Understanding the Role of Sleep in Complicated Grief

Stopped: Due to funding limitations

United States5 participantsStarted 2018-07-02

Plain-language 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.

Who can participate

Age range25 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical Global Impression Scales

Timeframe: 16 Weeks

Trial details

NCT IDNCT03533465

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-25