Bipolar Disorder Clinical Trial
Official title:
Brief Sleep Intervention for Suicide in Bipolar Disorder
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.
Bipolar disorder is characterized by episodes of depression as well as episodes of mania
(abnormally high mood). Individuals with bipolar disorder experience high rates of suicidal
ideation and behavior, with risk of death due to suicide estimated to be 20 times greater
than the general population. Moreover, some research suggests that among individuals treated
for bipolar disorder, approximately 40% will report a past suicide attempt. Other studies
suggest that between 25 and 65% of patients with bipolar disorder will attempt suicide and
that between 4 and 19% of these individuals will be successful. Among the DSM-IV-TR Axis I
disorders, suicide appears to be the highest in bipolar disorder. Individuals with bipolar
disorder have a greater likelihood of both current and past suicidal ideation if they have an
anxiety disorder, have an earlier age of onset, or a more severe course of illness.
Nevertheless, there is a continued need for information on the epidemiology and risk factors
for suicidal ideation and behavior in this population.
Several studies have shown that sleep difficulties (i.e., insomnia, hypersomnia, poor sleep
quality, and nightmares) are significantly associated with suicidal ideation, even after
controlling for depression. These disturbances are well documented during episodes of
depression and mania, but sleep disturbances have also been shown to persist during periods
of relative mood stability. A common symptom in bipolar patients experiencing manic episodes
is a reduced need for sleep, and several studies using polysomnography have identified
decreased REM sleep latency in manic episodes. Utilizing self-report measures, studies of
bipolar patients in depressive episodes have identified variable rates of hypersomnia and
insomnia as common factors. However, research conducted using laboratory-based
polysomnography during depressive episodes have reported disparate findings.
This proposal involves a test of a novel measure of sleep architecture in patients with
bipolar disorder, using a newly available home sleep monitoring device called Embla
(www.embla.com). This device sticks to the skin on the chest with standard EKG-adhesive
stickers and captures electrocardiogram (EKG) during sleep. The Embla device also measures
movement, snoring, body position, and light levels. The on-board storage allows 2-3 weeks of
nightly recording. By using an unobtrusive and potentially informative measure of sleep
architecture, this protocol will allow longitudinal, objective information about sleep
disturbance to be compared with corresponding mood states in patients with bipolar disorder.
Overall, this protocol is investigating the relationship between suicidality and sleep
disturbance as well as assessing whether a brief CBT intervention for sleep disturbance is
associated with reduced suicidal ideation and/or behavior. Since research suggests that CBT
is an effective adjunct treatment for reducing suicidality in this population, and that
treatment for insomnia can improve sleep in individuals with bipolar disorder, the present
research has important implications for the prevention and intervention of suicide in this
vulnerable population. To the investigators knowledge, no investigations have looked at the
effectiveness of CBT on both sleep and suicidality in bipolar disorder. Furthermore, while
past research has relied almost exclusively on subjective reports of sleep, this study
captures both subjective and objective measures of sleep.
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