Bipolar DisorderNCT01764074
Brief Sleep Intervention for Bipolar Disorder
A study testing Brief Sleep Intervention in people with Bipolar Disorder and Sleep Problems, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Sleep Problems, Suicidal Thoughts
- What is being tested?
- Brief Sleep Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65.
- Have a primary diagnosis of bipolar I or bipolar II disorder
- Have a reported sleep disturbance
- Have reported suicide ideation (thoughts)
Who cannot join
- 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
Show all 9Show fewer
- Current use of certain medications including beta blockers
- Known diagnosis of atrial fibrillation
- Acute major depressive or manic episode
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder, Sleep Problems, Suicidal Thoughts
- Being tested
- Brief Sleep Intervention
- Keywords
- Bipolar Disorder, Sleep Intervention, Suicide, Cognitive Behavioral Therapy, Sleep Quality
- Medical subject headings
- Bipolar Disorder, Parasomnias, Suicidal Ideation, Suicide, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Sleep InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brief Sleep Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Modified Scale of Suicidal Ideation (MSSI)
The MSSI is a 19-item clinical research instrument designed to quantify and assess suicidal intention.
Measured: 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.
Measured: 5 weeks
Secondary outcomes (1)
Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is a 10-item clinician-rated scale to measure the overall severity of depressive symptoms.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Louisa Grandin Sylvia, Massachusetts General Hospital
- Investigators
- Louisa G Sylvia, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764074
- Sponsor's protocol ID
- SRG-0-071-11
- Status last verified
- Mar 2019
- First submitted
- 7 Jan 2013
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Sleep Intervention for Suicide in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01764074
- Acronym / sponsor ID
- SRG-0-071-11
- Conditions
- Bipolar Disorder, Sleep Problems, Suicidal Thoughts
- Keywords
- Bipolar Disorder, Sleep Intervention, Suicide, Cognitive Behavioral Therapy, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- Jan 2013 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Sleep Intervention | Experimental | Behavioral: Brief Sleep InterventionEvery participant in the study will complete a 3-session sleep intervention with a clinician to improve sleep problems such as insomnia or hypersomnia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65.
- Have a primary diagnosis of bipolar I or bipolar II disorder
- Have a reported sleep disturbance
- Have reported suicide ideation (thoughts)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Sleep InterventionParticipants will meet with a therapist for three sessions to try to improve sleep problems (hypersomnia or insomnia, depending on the problems the participant has). | Behavioural | Brief Sleep Intervention |
Primary outcome
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.
1 secondary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa G Sylvia, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Sleep Intervention in people with Bipolar Disorder and Sleep Problems, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Frequency Coupling (HFC) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.