InsomniaNCT02658669
Cognitive-Behavioral Therapy for Veterans With TBI
A study testing Cognitive-Behavioral Therapy for Insomnia and Sleep Education in people with Insomnia and Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Insomnia, Traumatic Brain Injury
- What is being tested?
- 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
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult
Who may be able to join
- OEF/OIF/OND Veteran ages 18-55.
- Documented history of mild TBI (documented in the medical record and where possible from the VA TBI second-level evaluation)
- Loss of consciousness 30 minutes
- Post-traumatic amnesia 1 day
- At least 3 months post-TBI.
- A diagnosis of insomnia classified as:
Show all 10Show fewer
- Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria that include: trouble falling asleep, staying asleep, waking too early, and/or non-restorative sleep with accompanied daytime impairment in functioning for > 3 months, occurring at least 3 nights per week.
- Subjective sleep disturbance defined by a Pittsburgh Sleep Quality Index score >5 and Insomnia Severity Index score >7 at intake.
- No prior exposure to and/or treatment with CBT-I within the past 2 years.
- Must be stable on medication regimen for at least 1 month prior to enrollment in study.
Who cannot join
- History of a neurological disorder (besides TBI), dementia, or premorbid IQ <70.
- Schizophrenia, psychotic disorder, and/or bipolar disorder.
- Evidence of suicidality more than "low risk" as determined by the VA Comprehensive Suicide Risk Assessment (CSRA).
- Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea and/or periodic limb movements)
- Alcohol and/or substance abuse within the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI
Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms, delay recovery, and negatively affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has been shown to be an effective evidence-based treatment for insomnia, there are no published randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI.
Read the detailed description
This VA Rehabilitation Research and Development Career Development Award (CDA-2) proposal is designed to significantly advance the application of Behavioral Sleep Medicine practices in the treatment of Veterans seen in the VA Healthcare System, especially those recovering from traumatic brain injury (TBI). TBI has been deemed the "signature wound" of the Iraq and Afghanistan Wars, occurring in about 19.5% of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) service members. For many Veterans, mild traumatic brain injury (mTBI) can be associated with persistent post-concussive symptoms, especially sleep disturbances. Sleep disturbances are among the most frequent complaints following mTBI, with studies suggesting that over 93% of Veterans who experienced brain injuries develop chronic sleep problems. Of the sleep disturbances diagnosed in this patient population the most common is insomnia, observed in over 50% of patients. Chronic and untreated insomnia is known to be associated with and/or increase risk for psychiatric problems, suicidal ideation, and unhealthy lifestyles (e.g., alcohol/drug abuse), lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life, and may generally contribute to the persistence of post-concussive symptoms beyond the expected period of recovery. As such, treatment of sleep disturbance represents an essential component of Veteran care, one which may be particularly beneficial for Veterans with history of mTBI who commonly present to the clinic with complex multi-symptom concerns.
To address this important clinical issue, the proposed randomized clinical trial (RCT) will attempt to assess the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBT-I) versus a Sleep Education control in Veterans with insomnia and a history of mTBI. CBT-I is recommended by the American Academy of Sleep Medicine for treatment of chronic insomnia and has also been adopted by the VA within an Evidence Based Practice roll-out program. Despite the acceptance of CBT-I as a first line treatment for sleep disturbance, there are no published RCTs evaluating CBT-I in mTBI patient populations. Therefore, this proposed investigation will address this gap in the literature by assessing the efficacy of CBT-I in Veterans with history of head injury.
- Conditions
- Insomnia, Traumatic Brain Injury
- Being tested
- Cognitive-Behavioral Therapy for Insomnia, Sleep Education
- Keywords
- Insomnia, Injury, Brain, Traumatic Mild
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training.
Sleep EducationBehavioural
Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia | Experimental | 6-week manualized treatment designed to improve symptoms of chronic insomnia. Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia |
| Sleep Education | Active comparator | 6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity
Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.
Measured: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Secondary outcomes (4)
Change in Depressive Symptomatology
Change in depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9) a self-report measure of depression. Minimum value = 0; maximum value = 27. Lower scores indicate fewer depressive symptoms.
Measured: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Change in PTSD Stressor Specific Checklist 5
Change in PTSD symptoms assessed using the PTSD Stressor Specific Checklist 5 (PCL-5) a self-report measure of PTSD. Minimum score = 0, maximum score = 80. Lower scores indicate less PTSD symptomatology.
Measured: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Change in World Health Organization Disability Assessment Scale-2
Change in global functioning and disability will be assessed using the World Health Organization Disability Assessment Scale-2, a self-report measure. Minimum value = 0; maximum value = 100. Lower scores indicates less disability.
Measured: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Change in Pittsburgh Sleep Quality Index
Change in sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). Minimum value = 0; maximum value= 21. Lower score indicates less general sleep disturbance.
Measured: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start1 Apr 2016
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Henry J. Orff, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658669
- Sponsor's protocol ID
- D1512-W
- Status last verified
- Aug 2024
- First submitted
- 11 Jan 2016
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI
- ClinicalTrials.gov ID
- NCT02658669
- Acronym / sponsor ID
- D1512-W
- Conditions
- Insomnia, Traumatic Brain Injury
- Keywords
- Insomnia, Injury, Brain, Traumatic Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms, delay recovery, and negatively affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has been shown to be an effective evidence-based treatment for insomnia, there are no published randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI.
Detailed description
This VA Rehabilitation Research and Development Career Development Award (CDA-2) proposal is designed to significantly advance the application of Behavioral Sleep Medicine practices in the treatment of Veterans seen in the VA Healthcare System, especially those recovering from traumatic brain injury (TBI). TBI has been deemed the "signature wound" of the Iraq and Afghanistan Wars, occurring in about 19.5% of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) service members. For many Veterans, mild traumatic brain injury (mTBI) can be associated with persistent post-concussive symptoms, especially sleep disturbances. Sleep disturbances are among the most frequent complaints following mTBI, with studies suggesting that over 93% of Veterans who experienced brain injuries develop chronic sleep problems. Of the sleep disturbances diagnosed in this patient population the most common is insomnia, observed in over 50% of patients. Chronic and untreated insomnia is known to be associated with and/or increase risk for psychiatric problems, suicidal ideation, and unhealthy lifestyles (e.g., alcohol/drug abuse), lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life, and may generally contribute to the persistence of post-concussive symptoms beyond the expected period of recovery. As such, treatment of sleep disturbance represents an essential component of Veteran care, one which may be particularly beneficial for Veterans with history of mTBI who commonly present to the clinic with complex multi-symptom concerns.
To address this important clinical issue, the proposed randomized clinical trial (RCT) will attempt to assess the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBT-I) versus a Sleep Education control in Veterans with insomnia and a history of mTBI. CBT-I is recommended by the American Academy of Sleep Medicine for treatment of chronic insomnia and has also been adopted by the VA within an Evidence Based Practice roll-out program. Despite the acceptance of CBT-I as a first line treatment for sleep disturbance, there are no published RCTs evaluating CBT-I in mTBI patient populations. Therefore, this proposed investigation will address this gap in the literature by assessing the efficacy of CBT-I in Veterans with history of head injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy for Insomnia | Experimental | Behavioral: Cognitive-Behavioral Therapy for Insomnia6-week manualized treatment designed to improve symptoms of chronic insomnia. |
| Sleep Education | Active comparator | Behavioral: Sleep Education6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- OEF/OIF/OND Veteran ages 18-55.
- Documented history of mild TBI (documented in the medical record and where possible from the VA TBI second-level evaluation)
- At least 3 months post-TBI.
- A diagnosis of insomnia classified as:
- No prior exposure to and/or treatment with CBT-I within the past 2 years.
Key exclusion criteria (5 listed)
- History of a neurological disorder (besides TBI), dementia, or premorbid IQ <70.
- Schizophrenia, psychotic disorder, and/or bipolar disorder.
- Evidence of suicidality more than "low risk" as determined by the VA Comprehensive Suicide Risk Assessment (CSRA).
- Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea and/or periodic limb movements)
- Alcohol and/or substance abuse within the past 30 days.
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 |
|---|---|---|
| Cognitive-Behavioral Therapy for InsomniaAlso: CBT-IIntervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training. | Behavioural | Cognitive-Behavioral Therapy for Insomnia |
| Sleep EducationIntervention includes sleep hygiene education and education regarding the impact of TBI on sleep. | Behavioural | Sleep Education |
Primary outcome
Change in Insomnia Severity
Time frame: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.
4 secondary outcomes
Change in Depressive Symptomatology
Time frame: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Change in PTSD Stressor Specific Checklist 5
Time frame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Change in World Health Organization Disability Assessment Scale-2
Time frame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Change in Pittsburgh Sleep Quality Index
Time frame: Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The SRS fosters scientific investigations on all aspects of sleep and its disorders.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
Chronic Insomnia Disorder
Not yet recruiting
Visual and Auditory Stimulation in Intensive Care Patients
Dyspnea, Sleep Quality
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
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.
Henry J. Orff, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy for Insomnia and Sleep Education in people with Insomnia and Traumatic Brain Injury, run by VA Office of Research and Development 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 10 inclusion and 5 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 25 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Severity (time frame: Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-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 25 Sep 2024.