InsomniaNCT03261674
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
A study testing CBT-I and ABT-I in people with Insomnia and Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insomnia, Traumatic Brain Injury
- What is being tested?
- CBT-I and ABT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 25 Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female Veterans of any racial or ethnic group
- Independent Living (not in nursing home or VA Extended Care facility)
- Diagnosis of insomnia using the Duke structured interview
- Male or female chronic (>3 months since injury) mild Traumatic Brain Injury (mTBI).
- Subjects with PTSD will be included in this study as long as they do not meet criteria for depression described below.
- Use of CNS active medications that could significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks).
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- Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable.
- Use of medications, drugs, herbal remedies, or hormones specifically prescribed for treating sleep disturbances is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks).
- Subjects will be assessed for sleep apnea risk by the Berlin Questionnaire. Those with responses suggestive of high risk for apnea will be referred to Pulmonary Medicine for standard clinical screening, but will not be excluded. If subjects with obstructive sleep apnea are using CPAP, we will require stable use throughout the study.
Who cannot join
- Sleep-Related
- Excessive caffeine consumption (≥ 5 cups of coffee per day) and unable to reduce to ≤ 3 cups before lunch a day for ≥ 3 weeks prior to treatment.
- Subjects working a rotating shift or an unconventional daytime shift (ending after 1700 h, expected to be rare in the age group we are studying) will be ineligible.
- Neuropsychiatric
- Current or lifetime history of a psychiatric disorder with primary psychotic features.
- Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation.
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- Current or within the past 30 days: drug abuse or dependence (except nicotine).
- Current or expected cognitive behavior therapy for another condition (e.g. depression).
- More than one glass of wine or beer with dinner scheduled at least 3 to 4 hours before bedtime. - Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment.
- Folstein Mini-Mental State Exam (MMSE) < 24.
- Medical
- Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months. Unstable adult onset diabetes will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
About this study
Official title: Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury
The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).
Read the detailed description
Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain Injury (TBI) and often associated with extensive prescription of sleeping medications. Although safer, even the latest "sleeping pills" can lead to daytime impairment and risk of abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to medications. This trial will compare the relative efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Arousal-Based Therapy for Insomnia (ABT-I).
- Conditions
- Insomnia, Traumatic Brain Injury
- Being tested
- CBT-I, ABT-I
- Keywords
- Insomnia, Traumatic Brain Injury, Cognitive Behavioral Therapy, Veterans
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
Cognitive Behavioral Therapy for Insomnia (CBT-I)
ABT-IBehavioural
Arousal-Based Therapy for Insomnia (ABT-I)
| Study group | Role | What they receive |
|---|---|---|
| CBTI | Experimental | Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I) Receives: Behavioral: CBT-I |
| ABTI | Experimental | Arousal-Based Therapy for Insomnia (ABT-I) Receives: Behavioral: ABT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.
Measured: Change from baseline at week 8 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start28 Jun 2018
- Primary completion30 Sep 2023
- Study completion25 Apr 2024
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
- Model description
- Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ansgar J. Furst, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261674
- Sponsor's protocol ID
- B2319-I
- Status last verified
- Oct 2024
- First submitted
- 16 Aug 2017
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared through the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system: This system was developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as interconnectivity with other informatics platforms. Data will be uploaded to FITBIR according to the detailed instructions available on the FITBIR website.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia in Chronic Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03261674
- Acronym / sponsor ID
- B2319-I
- Conditions
- Insomnia, Traumatic Brain Injury
- Keywords
- Insomnia, Traumatic Brain Injury, Cognitive Behavioral Therapy, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).
Detailed description
Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain Injury (TBI) and often associated with extensive prescription of sleeping medications. Although safer, even the latest "sleeping pills" can lead to daytime impairment and risk of abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to medications. This trial will compare the relative efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Arousal-Based Therapy for Insomnia (ABT-I).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| CBTI | Experimental | Behavioral: CBT-IPatients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| ABTI | Experimental | Behavioral: ABT-IArousal-Based Therapy for Insomnia (ABT-I) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female Veterans of any racial or ethnic group
- Independent Living (not in nursing home or VA Extended Care facility)
- Diagnosis of insomnia using the Duke structured interview
- Male or female chronic (>3 months since injury) mild Traumatic Brain Injury (mTBI).
- Subjects with PTSD will be included in this study as long as they do not meet criteria for depression described below.
Key exclusion criteria (12 listed)
- Sleep-Related
- Excessive caffeine consumption (≥ 5 cups of coffee per day) and unable to reduce to ≤ 3 cups before lunch a day for ≥ 3 weeks prior to treatment.
- Subjects working a rotating shift or an unconventional daytime shift (ending after 1700 h, expected to be rare in the age group we are studying) will be ineligible.
- Neuropsychiatric
- Current or lifetime history of a psychiatric disorder with primary psychotic features.
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 |
|---|---|---|
| CBT-ICognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioural | CBTI |
| ABT-IArousal-Based Therapy for Insomnia (ABT-I) | Behavioural | ABTI |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Change from baseline at week 8 after treatment
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared through the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system: This system was developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as interconnectivity with other informatics platforms. Data will be uploaded to FITBIR according to the detailed instructions available on the FITBIR website.
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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.
Ansgar J. Furst, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, 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 CBT-I and ABT-I 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 9 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 31 Oct 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 31 Oct 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?
Insomnia Severity Index (ISI) (time frame: Change from baseline at week 8 after treatment). 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 31 Oct 2024.