Brief Sleep Intervention for Bipolar Disorder

NCT01764074 | Completed DMC

• 1 other identifier: SRG-0-071-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Sleep Problems; Suicidal Thoughts

Keywords

Bipolar Disorder; Sleep Intervention; Suicide; Cognitive Behavioral Therapy; Sleep Quality

Outcome Measures

Primary Outcomes (3)

• 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

• Modified Scale of Suicidal Ideation (MSSI)

  The MSSI is a 19-item clinical research instrument designed to quantify and assess suicidal intention.

  5 weeks

• 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 Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  5 weeks

Other Outcomes (3)

• Percentage of rapid eye movement (REM) sleep

  5 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  5 weeks

• Young Mania Rating Scale (YMRS)

  5 weeks

Study Arms (1)

Brief Sleep Intervention

EXPERIMENTAL

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

Interventions

Brief Sleep Intervention BEHAVIORAL

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).

Brief Sleep Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Parasomnias; Suicidal Ideation; Suicide; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Louisa G Sylvia, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Psychiatry

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

US (1)