Insomnia ChronicNCT04377009
Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI
A study testing Sleep Healthy Using the Internet (SHUTi) in people with Insomnia Chronic and Mild Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Insomnia Chronic, Mild Traumatic Brain Injury
- What is being tested?
- Sleep Healthy Using the Internet (SHUTi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 30 Apr 2023
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64
- Service member or veteran
- Ability to provide electronic informed consent and follow study-related instructions
- Presence of clinical insomnia for a period of at least 1 month prior to consent as confirmed by self-reported Insomnia Severity Index (ISI) score ≥15 and Pittsburgh Sleep Quality Index ≥5
- History of mild traumatic brain injury ≥6 months prior to consent, including blast-related, as confirmed by a telephone administered traumatic brain injury screener
- Reliable access to a telephone and the Internet via their computer or smartphone
- Stable regimen of medications for sleep or potentially affecting sleep over prior 1 month as confirmed by clinical history review
Who cannot join
- Current or previous cognitive behavioral therapy for insomnia (CBT-I) or electronic CBT- I intervention; participants may still receive other approved therapies provided via standard of care
- Life expectancy of <6 months
- Rapidly progressive illnesses (i.e., late-stage cancer, neurodegenerative conditions, major organ failure, etc.)
- Self-reported history of moderate to severe substance use disorders with the exception of nicotine
- Active bipolar disorder or psychosis that could be worsened by mild sleep restriction as part of electronic CBT-I
- Routine irregular work schedules or sleep patterns defined as shift work greater than 1 day per week
- Any other considerations that in the view of the principal investigator may adversely affect patient safety, participation, or scientific validity of the data being collected
Trial locations and contacts
1 site in 1 country.
United States1 site
Uniformed Services University
Bethesda, Maryland, 20817
About this study
Official title: A Randomized, Controlled, Blinded Study of Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of Traumatic Brain Injury
This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I program being studied has been customized specifically for military service members.
The study will assess if the customized internet-guided CBT-I program will positively improve clinical measures of insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.
Read the detailed description
Traumatic brain injury (TBI) represents a major health problem in United States military service members. Mild traumatic brain injury, also called "concussion", accounts for approximately 90% of the overall cases of TBI. Mild TBI (mTBI) is associated with various debilitating symptoms, such as headache, mood disorders, and sleep alterations. A high percentage of service members and veterans with suspected or confirmed mTBI are also diagnosed with insomnia or other sleep disorders.
In-person cognitive behavioral therapy for insomnia (CBT-I) has been documented as an effective therapy for treating insomnia. However, implementation within the Military Healthcare System (MHS) has been lacking due to lack of appropriately trained practitioners. Additionally, patients may overlook in-person therapy due to significant time commitment.
This study is a double-blind, randomized, controlled clinical trial to assess internet-guided CBT-I in military service members with insomnia and mTBI. The primary outcome measure for efficacy is the Insomnia Severity Index (ISI) with secondary cross-validation using the Pittsburgh Sleep Quality Index (PSQI). Approximately 200 participants will be randomized to treatment or control groups. Participants receiving active CBT-I will follow a 9-week internet-guided program requiring daily follow-up through an online portal that may be accessed via computer or phone. Participants in the control group will also receive access to an online portal for 9 weeks.
Primary analysis is percent improvement in severity symptoms assessed pre- and post-treatment. Secondary analysis is percent retained improvement in severity of symptoms assessed post-treatment and long-term follow-up at 6 months.
Secondary outcome measures will capture a variety of known and suspected insomnia precursors, predictors, or correlates and functional outcomes.
- Conditions
- Insomnia Chronic, Mild Traumatic Brain Injury
- Being tested
- Sleep Healthy Using the Internet (SHUTi), Education Control Program
- Keywords
- Cognitive Behavioral Therapy, Insomnia, Concussion, Mild Traumatic Brain Injury
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Healthy Using the Internet (SHUTi)Device
Cognitive behavioral therapy delivered via internet-guided program customized for military service members
Education Control ProgramOther
Online portal designed to inform participants about healthy lifestyle activities and general insomnia information
| Study group | Role | What they receive |
|---|---|---|
| Active CBT-I | Experimental | Internet-guided cognitive behavioral therapy Receives: Device: Sleep Healthy Using the Internet (SHUTi) |
| Control | Other | Education control program Receives: Other: Education Control Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score.
Measured: Baseline and 9 weeks
Insomnia Severity Index (ISI)
Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score.
Measured: Baseline and 3 months
Secondary outcomes (12)
Patient Health Questionnaire 9 (PHQ-9)
Comparison of changes in PHQ-9 scores from baseline to post-intervention
Measured: Baseline and 9 weeks
Patient Health Questionnaire 9 (PHQ-9)
Comparison of changes in PHQ-9 scores from baseline to post-intervention
Measured: Baseline and 3 months
PTSD Checklist for DSM-5 (PCL-5)
Comparison of changes in PCL-5 scores from baseline to post-intervention
Measured: Baseline and 9 weeks
PTSD Checklist for DSM-5 (PCL-5)
Comparison of changes in PCL-5 scores from baseline to post-intervention
Measured: Baseline and 3 months
Migraine Disability Assessment (MIDAS)
Comparison of changes in MIDAS scores from baseline to post-intervention
Measured: Baseline and 9 weeks
Migraine Disability Assessment (MIDAS)
Comparison of changes in MIDAS scores from baseline to post-intervention
Measured: Baseline and 3 months
Pittsburgh Sleep Quality Index (PSQI)
Comparison of changes in PSQI scores from baseline to post-intervention
Measured: Baseline and 9 weeks
Pittsburgh Sleep Quality Index (PSQI)
Comparison of changes in PSQI scores from baseline to post-intervention
Measured: Baseline and 3 months
Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A)
Comparison of changes in PSQI-A scores from baseline to post-intervention
Measured: Baseline and 9 weeks
Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A)
Comparison of changes in PSQI-A scores from baseline to post-intervention
Measured: Baseline and 3 months
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Comparison of changes in FACIT-F scores from baseline to post-intervention
Measured: Baseline and 9 weeks
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Comparison of changes in FACIT-F scores from baseline to post-intervention
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start7 Jul 2020
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
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 Insomnia ChronicStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Center for Neuroscience and Regenerative Medicine (CNRM)
- Responsible party
- Sponsor
- Investigators
- David L Brody, MD, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377009
- Sponsor's protocol ID
- CNRM-02-9662
- Status last verified
- Aug 2023
- First submitted
- 4 May 2020
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.
Publications
Malarkey ME, Fu AJ, Mannan N, Shaw OM, Haight TJ, Cota MR, Jahed NC, Werner JK, Brody DL. Internet-Guided Cognitive Behavioral Therapy for Insomnia Among Patients With Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2420090. doi: 10.1001/jamanetworkopen.2024.20090.
PubMed 38980675
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Blinded Study of Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04377009
- Acronym / sponsor ID
- CNRM-02-9662
- Conditions
- Insomnia Chronic, Mild Traumatic Brain Injury
- Keywords
- Cognitive Behavioral Therapy, Insomnia, Concussion, Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 6 May 2020 (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.
This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I program being studied has been customized specifically for military service members.
The study will assess if the customized internet-guided CBT-I program will positively improve clinical measures of insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.
Detailed description
Traumatic brain injury (TBI) represents a major health problem in United States military service members. Mild traumatic brain injury, also called "concussion", accounts for approximately 90% of the overall cases of TBI. Mild TBI (mTBI) is associated with various debilitating symptoms, such as headache, mood disorders, and sleep alterations. A high percentage of service members and veterans with suspected or confirmed mTBI are also diagnosed with insomnia or other sleep disorders.
In-person cognitive behavioral therapy for insomnia (CBT-I) has been documented as an effective therapy for treating insomnia. However, implementation within the Military Healthcare System (MHS) has been lacking due to lack of appropriately trained practitioners. Additionally, patients may overlook in-person therapy due to significant time commitment.
This study is a double-blind, randomized, controlled clinical trial to assess internet-guided CBT-I in military service members with insomnia and mTBI. The primary outcome measure for efficacy is the Insomnia Severity Index (ISI) with secondary cross-validation using the Pittsburgh Sleep Quality Index (PSQI). Approximately 200 participants will be randomized to treatment or control groups. Participants receiving active CBT-I will follow a 9-week internet-guided program requiring daily follow-up through an online portal that may be accessed via computer or phone. Participants in the control group will also receive access to an online portal for 9 weeks.
Primary analysis is percent improvement in severity symptoms assessed pre- and post-treatment. Secondary analysis is percent retained improvement in severity of symptoms assessed post-treatment and long-term follow-up at 6 months.
Secondary outcome measures will capture a variety of known and suspected insomnia precursors, predictors, or correlates and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active CBT-I | Experimental | Device: Sleep Healthy Using the Internet (SHUTi)Internet-guided cognitive behavioral therapy |
| Control | Other | Other: Education Control ProgramEducation control program |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-64
- Service member or veteran
- Ability to provide electronic informed consent and follow study-related instructions
- Presence of clinical insomnia for a period of at least 1 month prior to consent as confirmed by self-reported Insomnia Severity Index (ISI) score ≥15 and Pittsburgh Sleep Quality Index ≥5
- History of mild traumatic brain injury ≥6 months prior to consent, including blast-related, as confirmed by a telephone administered traumatic brain injury screener
Key exclusion criteria (7 listed)
- Current or previous cognitive behavioral therapy for insomnia (CBT-I) or electronic CBT- I intervention; participants may still receive other approved therapies provided via standard of care
- Life expectancy of <6 months
- Rapidly progressive illnesses (i.e., late-stage cancer, neurodegenerative conditions, major organ failure, etc.)
- Self-reported history of moderate to severe substance use disorders with the exception of nicotine
- Active bipolar disorder or psychosis that could be worsened by mild sleep restriction as part of electronic CBT-I
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 Healthy Using the Internet (SHUTi)Cognitive behavioral therapy delivered via internet-guided program customized for military service members | Device | Active CBT-I |
| Education Control ProgramOnline portal designed to inform participants about healthy lifestyle activities and general insomnia information | Other | Control |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline and 9 weeks
Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score.
Insomnia Severity Index (ISI)
Time frame: Baseline and 3 months
Comparison of changes in ISI scores from baseline to post-intervention. A clinically meaningful change will be defined as >=25% reduction in total symptom score.
12 secondary outcomes
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline and 9 weeks
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline and 3 months
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline and 9 weeks
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline and 3 months
Migraine Disability Assessment (MIDAS)
Time frame: Baseline and 9 weeks
Migraine Disability Assessment (MIDAS)
Time frame: Baseline and 3 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 9 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 3 months
Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A)
Time frame: Baseline and 9 weeks
Pittsburgh Sleep Quality Index (PSQI) with Addendum for PTSD (PSQI-A)
Time frame: Baseline and 3 months
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: Baseline and 9 weeks
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: Baseline and 3 months
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 21 Aug 2023.
- Derived from this study: PubMed 38980675Malarkey ME, Fu AJ, Mannan N, Shaw OM, Haight TJ, Cota MR, Jahed NC, Werner JK, Brody DL. Internet-Guided Cognitive Behavioral Therapy for Insomnia Among Patients With Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2420090. doi: 10.1001/jamanetworkopen.2024.20090.
- Individual participant dataSharing planned: Yes. Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.
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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.
David L Brody, MD, PhD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Healthy Using the Internet (SHUTi) in people with Insomnia Chronic and Mild Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 7 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 21 Aug 2023. 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?
Insomnia Severity Index (ISI) (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 NCT04377009, 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 21 Aug 2023.