Brief Sleep Intervention for Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT01764074|
Recruitment Status : Unknown
Verified March 2016 by Louisa Grandin Sylvia, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 9, 2013
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Sleep Problems Suicidal Thoughts||Behavioral: Brief Sleep Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Brief Sleep Intervention for Suicide in Bipolar Disorder|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2017|
Experimental: Brief Sleep Intervention
Every participant in the study will complete a 3-session sleep intervention with a clinician to improve sleep problems such as insomnia or hypersomnia.
Behavioral: Brief Sleep Intervention
Participants will meet with a therapist for three sessions to try to improve sleep problems (hypersomnia or insomnia, depending on the problems the participant has).
- High Frequency Coupling (HFC) [ Time Frame: 6 weeks ]
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).
- Modified Scale of Suicidal Ideation (MSSI) [ Time Frame: 5 weeks ]The MSSI is a 19-item clinical research instrument designed to quantify and assess suicidal intention.
- The Columbia-Suicide Severity Rating Scale (CSSRS) [ Time Frame: 5 weeks ]The CSSRS records suicidal behavior on the basis of attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, and preparatory acts or behaviors.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 5 weeks ]The MADRS is a 10-item clinician-rated scale to measure the overall severity of depressive symptoms.
- Percentage of rapid eye movement (REM) sleep [ Time Frame: 5 weeks ]
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 5 weeks ]9-item self-rated questionnaire that measures sleep quality and sleep disturbance over the past month
- Young Mania Rating Scale (YMRS) [ Time Frame: 5 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764074
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Louisa G Sylvia, Ph.D.||Massachusetts General Hospital|