Brief Sleep Intervention for Bipolar Disorder

Completed · Not applicable

Conditions studied: Bipolar Disorder, Sleep Problems, Suicidal Thoughts

In brief

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.

Key facts

Study ID

NCT01764074

Run by

Massachusetts General Hospital

People needed

60

Starts

2013-01-01

Expected to finish

2018-11-15

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65.
• Have a primary diagnosis of bipolar I or bipolar II disorder
• Have a reported sleep disturbance
• Have reported suicide ideation (thoughts)

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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