Bipolar Disorder Clinical Trial
Official title:
Brief Sleep Intervention for Suicide in Bipolar Disorder
Verified date | March 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Individuals with bipolar disorder (BD) experience extreme mood swings, or episodes of depression and (hypo)mania. These episodes are associated with poor functioning, worse course of illness, and high rates of suicidality. It is estimated that between 25 to 65% of individuals with BD attempt suicide and 4 to 19% of individuals with BD eventually die by suicide. Sleep disturbance has been identified as a primary prodromal as well as causal symptom of mood episodes and recently, has been found to be associated with higher rates of suicidal ideation and behavior. Given the role that sleep may have in mood stability and suicidality in BD, it seems imperative to further understand the association of sleep and suicide and how sleep interventions may be useful to reduce suicidality in BD. Thus, the primary aim of this study is to use an innovative home sleep monitoring device, or the Embla, to examine the association of sleep and suicidality in adult outpatients with BD. The Embla is unique in that it is a non-invasive device that can characterize sleep profiles by measuring the degree of sleep fragmentation and percentage of rapid eye movement (REM) sleep. The study duration is five to six weeks such that patients wear the Embla device for Week 1, participate in a brief sleep intervention for suicide during Weeks 2 and 3, and 4, and then wear the Embla device for one more week (Week 5). This intervention consists of three, 60-min sessions and utilizes cognitive-behavioral therapy strategies (e.g., psychoeducation, cognitive re-structuring, problem solving, behavioral activation) to improve sleep disturbance. The investigators expect that individuals at study entry with more sleep disturbance (as measured by the Embla) will report more suicidal ideation and behaviors. The investigators also hypothesize that from pre- to post-intervention, individuals will report less sleep disturbance as well as suicidal ideation and behaviors. Data from this research has immediate and practical implications for providers and their patients as it the first examination of sleep phenotypes and suicide in a high risk population as well as to explore the association of improvements in sleep with suicidality.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 15, 2018 |
Est. primary completion date | November 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Age 18-65. - Have a primary diagnosis of bipolar I or bipolar II disorder - Have a reported sleep disturbance - Have reported suicide ideation (thoughts) Exclusion Criteria: - Any known or active sleep disorder (such as sleep apnea) - Any history of significant cardiac, pulmonary, neurological, hepatic, or renal disease - Any history of malignancy, chemotherapy, or radiation - Any skin condition that would prevent wearing the device - Pregnancy - Current or suspected sleep apnea - Current use of certain medications including beta blockers - Known diagnosis of atrial fibrillation - Acute major depressive or manic episode |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | American Foundation for Suicide Prevention |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of rapid eye movement (REM) sleep | 5 weeks | ||
Other | Pittsburgh Sleep Quality Index (PSQI) | 9-item self-rated questionnaire that measures sleep quality and sleep disturbance over the past month | 5 weeks | |
Other | Young Mania Rating Scale (YMRS) | The YMRS aims to quantify the degree of mania in patients who already have a diagnosis of BD and is the most widely studied instrument for mania | 5 weeks | |
Primary | High Frequency Coupling (HFC) | High Frequency Coupling (HFC) is a measure of the portion of unstable versus stable sleep, and this is measured by the Embla device. HFC has been validated in a variety of circumstances, and correlates with cardiovascular and mental health outcomes(Thomas, 2006). |
6 weeks | |
Primary | Modified Scale of Suicidal Ideation (MSSI) | The MSSI is a 19-item clinical research instrument designed to quantify and assess suicidal intention. | 5 weeks | |
Primary | The Columbia-Suicide Severity Rating Scale (CSSRS) | The CSSRS records suicidal behavior on the basis of attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, and preparatory acts or behaviors. | 5 weeks | |
Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item clinician-rated scale to measure the overall severity of depressive symptoms. | 5 weeks |
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