Brief Sleep Intervention for Bipolar Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
Louisa Grandin Sylvia, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01764074
First received: January 7, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Bipolar Disorder
Sleep Problems
Suicidal Thoughts
Behavioral: Brief Sleep Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Brief Sleep Intervention for Suicide in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • High Frequency Coupling (HFC) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The CSSRS records suicidal behavior on the basis of attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, and preparatory acts or behaviors.


Secondary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    The MADRS is a 10-item clinician-rated scale to measure the overall severity of depressive symptoms.


Other Outcome Measures:
  • Percentage of rapid eye movement (REM) sleep [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764074

Contacts
Contact: Rebecca Montana, B.A. 617-724-9033 rmontana@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
American Foundation for Suicide Prevention
Investigators
Principal Investigator: Louisa G Sylvia, Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Louisa Grandin Sylvia, Instructor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01764074     History of Changes
Other Study ID Numbers: SRG-0-071-11
Study First Received: January 7, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Bipolar Disorder
Sleep Intervention
Suicide
Cognitive Behavioral Therapy
Sleep Quality

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Dyssomnias
Parasomnias
Sleep Disorders
Suicidal Ideation
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Self-Injurious Behavior
Signs and Symptoms
Suicide

ClinicalTrials.gov processed this record on October 23, 2014