InsomniaNCT01770587
A Sleep-Oriented Intervention for Suicidal Behaviors
A study testing Behavioral Insomnia Treatment in people with Insomnia and Suicidal Ideation, run by Stanford University at 1 site in United States.
Trial summary
An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Suicidal Ideation
- What is being tested?
- Behavioral Insomnia Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Age 18 or older
- Clinically significant sleep disturbances
- Diagnosis of depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, Dept. of Psychiatry and Behavioral Sciences
Stanford, California, 94304
About this study
An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation.
- Conditions
- Insomnia, Suicidal Ideation
- Being tested
- Behavioral Insomnia Treatment
- Keywords
- Insomnia, Sleep, Behavioral Medicine, Suicide, Suicidal Ideation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Insomnia TreatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Insomnia Treatment | Experimental | Brief Behavioral Insomnia Treatment Receives: Behavioral: Behavioral Insomnia Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation
Measured: Change from Baseline in Suicidal Ideation at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca Ann Bernert, Stanford University
- Investigators
- Rebecca A Bernert, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770587
- Sponsor's protocol ID
- 22393
- Other IDs
- K23MH093490
- Status last verified
- Feb 2020
- First submitted
- 14 Jan 2013
- Last updated
- 2 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sleep-Oriented Intervention for Suicidal Behaviors
- ClinicalTrials.gov ID
- NCT01770587
- Acronym / sponsor ID
- 22393
- Conditions
- Insomnia, Suicidal Ideation
- Keywords
- Insomnia, Sleep, Behavioral Medicine, Suicide, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 18 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.
An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Insomnia Treatment | Experimental | Behavioral: Behavioral Insomnia TreatmentBrief Behavioral Insomnia Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Behavioral Insomnia Treatment | Behavioural | Behavioral Insomnia Treatment |
Primary outcome
Suicidal Ideation
Time frame: Change from Baseline in Suicidal Ideation at 8 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 2 Mar 2020.
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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.
Rebecca A Bernert, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Insomnia Treatment in people with Insomnia and Suicidal Ideation, run by Stanford University 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?
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 2 Mar 2020. 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?
Suicidal Ideation (time frame: Change from Baseline in Suicidal Ideation at 8 weeks). 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 2 Mar 2020.