InsomniaVets SleepNCT03366870
Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
A study testing Computerized Cognitive Behavioral Therapy for Insomnia and Sleep Education in people with Insomnia and Physical Health Functioning, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Physical Health Functioning, Mental Health Functioning
- What is being tested?
- Computerized Cognitive Behavioral Therapy for Insomnia and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2018to 16 Jun 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 55
- History of deployment in the Global War on Terror
- Eligible to receive care through VA ECHCS
- Reliable access to the Internet
- English speaking
- Able to provide informed consent
- Current insomnia diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) criteria
Who cannot join
- Currently enrolled in/participating in other intervention research studies
- Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
- Currently receiving formal psychological treatment for insomnia (not including sleep medications)
- Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
- History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
- Untreated seizures or seizure disorder
Show all 12Show fewer
- Physical illness that is active, unstable, degenerative, and/or progressive
- Currently pregnant or plan to become pregnant in the next 6 months
- Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns
- Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi
- Current non-alcohol Substance Use Disorder, excluding Cannabis Use Disorder, as determined by chart review and/or self-report screen of drug use (> 1 time) in past 3 months
- Current Alcohol Use Diagnosis, as determined by SCID 5 module, in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
About this study
Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA) and Department of Defense (DoD). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.
- Being tested
- Computerized Cognitive Behavioral Therapy for Insomnia, Sleep Education
- Keywords
- CBT-I, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Behavioral Therapy for InsomniaBehavioural
Also called cCBT-I
A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.
Sleep EducationBehavioural
A web-based program will deliver components of sleep education via an Internet platform.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Intervention 1 | Experimental | A web-based program will deliver components of CBT-I on a time and event-based schedule. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention. Receives: Behavioral: Computerized Cognitive Behavioral Therapy for Insomnia |
| Computerized Intervention 2 | Experimental | A web-based program will deliver components of sleep education via an Internet platform. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention. Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index
The primary analyses will be the intent-to-treat comparison between groups of the change in insomnia symptom severity as measured by the ISI from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve precision of the estimate, and any potential confounders discovered in the randomization check.
Measured: Baseline and 9 Weeks
Maintenance of Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index at 6-months and 1-Year Post-Intervention
A similar analysis will be performed for the above noted insomnia severity outcome on the change from Time 1 to Time 3 and to Time 4 to determine persistence of group differences to six-months and one-year post-intervention.
Measured: Baseline, 6-Months and 1-Year
Secondary outcomes (2)
Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36
A similar analysis will be performed with physical health and mental health functioning as the outcomes, based on self-reported responses to the Veteran's SF-36 measure.
Measured: Baseline and 9 Weeks
Maintenance of Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36 at 6-months and 1-Year Post-Intervention
A similar analysis will be performed for the above noted outcomes on the change from Time 1 to Time 3 and to Time 4 to determine persistence of group differences to six-months and one-year post-intervention.
Measured: Baseline, 6-Months and 1-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start24 Mar 2018
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Military Suicide Research Consortium, Denver Research Institute
- Responsible party
- Sponsor
- Investigators
- Sarra Nazem, PhD, Principal investigator, VHAECH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366870
- Sponsor's protocol ID
- 17-0920
- Acronym
- Vets Sleep
- Status last verified
- Jun 2020
- First submitted
- 28 Nov 2017
- Last updated
- 1 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nazem S, Barnes SM, Forster JE, Hostetter TA, Monteith LL, Kramer EB, Gaeddert LA, Brenner LA. Efficacy of an Internet-Delivered Intervention for Improving Insomnia Severity and Functioning in Veterans: Randomized Controlled Trial. JMIR Ment Health. 2023 Nov 24;10:e50516. doi: 10.2196/50516.
PubMed 37999953
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
- ClinicalTrials.gov ID
- NCT03366870
- Acronym / sponsor ID
- Vets Sleep / 17-0920
- Keywords
- CBT-I, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Military Suicide Research Consortium, Denver Research Institute
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 8 Dec 2017 (actual)
- 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.
Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA) and Department of Defense (DoD). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Intervention 1 | Experimental | Behavioral: Computerized Cognitive Behavioral Therapy for InsomniaA web-based program will deliver components of CBT-I on a time and event-based schedule. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention. |
| Computerized Intervention 2 | Experimental | Behavioral: Sleep EducationA web-based program will deliver components of sleep education via an Internet platform. Pre and Post-Intervention assessments will be administered to determine the efficacy of the intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 55
- History of deployment in the Global War on Terror
- Eligible to receive care through VA ECHCS
- Reliable access to the Internet
- English speaking
Key exclusion criteria (12 listed)
- Currently enrolled in/participating in other intervention research studies
- Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
- Currently receiving formal psychological treatment for insomnia (not including sleep medications)
- Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
- History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
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 |
|---|---|---|
| Computerized Cognitive Behavioral Therapy for InsomniaAlso: cCBT-IA computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I. | Behavioural | Computerized Intervention 1 |
| Sleep EducationA web-based program will deliver components of sleep education via an Internet platform. | Behavioural | Computerized Intervention 2 |
Primary outcome
Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index
Time frame: Baseline and 9 Weeks
The primary analyses will be the intent-to-treat comparison between groups of the change in insomnia symptom severity as measured by the ISI from Time 1 to Time 2. Statistical inference regarding the difference between intervention groups will be based on the estimated coefficient for a group indicator variable in each of three analysis of covariance models with the change from Time 1 to Time 2 for each outcome serving as the dependent variable. Additional covariates will include the baseline value of the outcome to improve precision of the estimate, and any potential confounders discovered in the randomization check.
Maintenance of Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index at 6-months and 1-Year Post-Intervention
Time frame: Baseline, 6-Months and 1-Year
A similar analysis will be performed for the above noted insomnia severity outcome on the change from Time 1 to Time 3 and to Time 4 to determine persistence of group differences to six-months and one-year post-intervention.
2 secondary outcomes
Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36
Time frame: Baseline and 9 Weeks
Maintenance of Change in Physical Health and Mental Health Functioning as Measured by the Veteran's SF-36 at 6-months and 1-Year Post-Intervention
Time frame: Baseline, 6-Months and 1-Year
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 1 Jul 2020.
- Derived from this study: PubMed 37999953Nazem S, Barnes SM, Forster JE, Hostetter TA, Monteith LL, Kramer EB, Gaeddert LA, Brenner LA. Efficacy of an Internet-Delivered Intervention for Improving Insomnia Severity and Functioning in Veterans: Randomized Controlled Trial. JMIR Ment Health. 2023 Nov 24;10:e50516. doi: 10.2196/50516.
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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.
Sarra Nazem, PhD principal investigator
VHAECH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Behavioral Therapy for Insomnia and Sleep Education in people with Insomnia and Physical Health Functioning, run by University of Colorado, Denver 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 7 inclusion and 12 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 1 Jul 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?
Change in Insomnia Symptom Severity as Measured by the Insomnia Severity Index (time frame: Baseline and 9 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03366870, which also lists 1 linked publication.
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 1 Jul 2020.