Understanding the Role of Sleep in Complicated Grief

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep, Grief

Intervention / Treatment
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* Behavioral: Complicated Grief Therapy (CGT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complicated Grief Treatment (CGT)<br>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. | Behavioral: Complicated Grief Therapy (CGT)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scales | Measure of Clinical Improvement and Severity of illness on a scale of 1-7; 1 being Very Much Improved; 7 being Very Much Worse | 16 Weeks |