Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01764074 · ClinicalTrials.gov registry record · NA
Brief Sleep Intervention for Bipolar Disorder
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01764074: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01764074 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764074, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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 pra
Primary Outcome
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).
Interventions
- BEHAVIORAL Brief Sleep Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-11-15 |
| Phase | NA |
What the finished NCT01764074 record still lists
NCT01764074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Brief Sleep Intervention is the first listed.
NCT01764074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01764074 about?
NCT01764074 is a clinical study titled "Brief Sleep Intervention for 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...
What is the current status of trial NCT01764074?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2013-01. Estimated completion is 2018-11-15.
What interventions are being tested in trial NCT01764074?
The interventions under investigation include: Brief Sleep Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01764074?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01764074's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia