InsomniaNCT01958541
A Brief Behavioral Sleep Intervention for Depression Among Military Veterans
A study testing Sleep Intervention I and Sleep Intervention II in people with Insomnia and Depression, run by Stanford University at 2 sites in United States.
Trial summary
This study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Depression, Suicidal Ideation
- What is being tested?
- Sleep Intervention I and Sleep Intervention II
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Sep 2017
- 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
- No healthy volunteers
- Adult, Older adult
- Age 18 or older
- Veteran
- Insomnia Symptoms
- Depression
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Healthcare System
Palo Alto, California, 94304
Stanford University
Stanford, California, 94305
About this study
This study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans.
- Conditions
- Insomnia, Depression, Suicidal Ideation
- Being tested
- Sleep Intervention I, Sleep Intervention II
- Keywords
- Sleep, Insomnia, Suicidal Symptoms, Suicidal Ideation, Military Veteran, Service Member, Depression
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Intervention IBehavioural
Insomnia-focused behavioral treatment (4 sessions).
Sleep Intervention IIBehavioural
Insomnia-focused behavioral treatment (4 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention I | Experimental | This non-medication group treatment (Sleep Intervention I) consists of four 90-minute sessions. Receives: Behavioral: Sleep Intervention I |
| Behavioral Intervention II | Active comparator | This non-medication group treatment (Sleep Intervention II) consists of four 90-minute sessions. Receives: Behavioral: Sleep Intervention II |
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 7 weeks
Secondary outcomes (1)
Insomnia Symptoms
Measured: Change from Baseline in Insomnia Symptoms at 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2017
- Study completionSep 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Rebecca Ann Bernert, Stanford University
- Investigators
- Rebecca A Bernert, Ph.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958541
- Sponsor's protocol ID
- 22427
- Other IDs
- W81XWH-10-2-0178
- Status last verified
- Apr 2018
- First submitted
- 7 Oct 2013
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Behavioral Sleep Intervention for Depression Among Military Veterans
- ClinicalTrials.gov ID
- NCT01958541
- Acronym / sponsor ID
- 22427
- Conditions
- Insomnia, Depression, Suicidal Ideation
- Keywords
- Sleep, Insomnia, Suicidal Symptoms, Suicidal Ideation, Military Veteran, Service Member, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Study start
- Mar 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Oct 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.
This study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention I | Experimental | Behavioral: Sleep Intervention IThis non-medication group treatment (Sleep Intervention I) consists of four 90-minute sessions. |
| Behavioral Intervention II | Active comparator | Behavioral: Sleep Intervention IIThis non-medication group treatment (Sleep Intervention II) consists of four 90-minute sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Sleep Intervention IInsomnia-focused behavioral treatment (4 sessions). | Behavioural | Behavioral Intervention I |
| Sleep Intervention IIInsomnia-focused behavioral treatment (4 sessions). | Behavioural | Behavioral Intervention II |
Primary outcome
Suicidal Ideation
Time frame: Change from Baseline in Suicidal Ideation at 7 weeks
1 secondary outcome
Insomnia Symptoms
Time frame: Change from Baseline in Insomnia Symptoms at 7 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 26 Apr 2018.
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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, Ph.D. principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Intervention I and Sleep Intervention II in people with Insomnia and Depression, run by Stanford University at 2 sites 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 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 7 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 26 Apr 2018.