Traumatic Brain InjurySAA-TBINCT03277859
Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
A study testing SAA-TBI in people with Traumatic Brain Injury and Post-concussive Headaches, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Brain Injury, Post-concussive Headaches
- What is being tested?
- SAA-TBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2017to 30 Jun 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18 and 55
- Able to provide informed consent
- History of mTBI per the Ohio State University TBI-ID (OSU-TBI-ID)
- History of PCH pain (TTH, migraine, or mixed), with onset of pain or increase in previous headache pain having occurred within one month of mTBI as determined by structured examination using criteria outlined in the International Classification of Headache Disorders-3 beta (ICHD-3 beta)
- Duration of PCH pain being greater than one year as determined by structured medical examination
- Score of >49 on the Headache Impact Test-6 (HIT-6)
- Medical clearance by study provider to participate in yoga protocol
Who cannot join
- Younger than 18, or older than 55 years of age
- Active substance dependence, excluding Cannabis dependence (based on local issues regarding the legality of cannabis), as determined by structured clinical interview
- Moderate to severe TBI as determined per the OSU-TBI-ID
- Identification of active psychosis as determined by structured clinical interview
- Failing to receive medical clearance by study provider;
- Inability to participate in the manualized intervention without postures being significantly modified
- Already participating in an ongoing consistent yoga practice (two or more times weekly)
- Involvement in another research interventional trial aimed at addressing pain-related symptoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
About this study
The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated.
Read the detailed description
A signature injury being sustained by Veterans from recent conflicts is mild traumatic brain injury (mTBI). For some, this condition is associated with multiple disabling post-concussive symptoms, including post-concussive headaches (PCH). PCHs are notoriously resistant to medication alone, and are associated with increased muscle tension, avoidance of physical activities, and anxiety related to having chronic pain. In this study, the feasibility (ease of implementation) of the design elements of an interventional trial of Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) will be explored. Yoga is operationalized as a practice involving physical postures, breath awareness, breathing exercises and mindfulness meditation. It is conceptualized as having three "active ingredients" (i.e., regulation of the autonomic nervous system via physical activity/breathing exercises, release of muscular tension associated with headaches, and mindfulness/acceptance). The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of an SAA-TBI intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated. Project aims will be evaluated using an experimental design where participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU). The participants in the waitlist condition will be offered SAA-TBI, after the initial group has completed the intervention. Both groups of participants will complete multiple measures at baseline and after the conclusion of the intervention. Maintenance among the intervention group will also be explored. Participants will be asked to complete daily homework documenting their headaches and yoga practice outside of class, and be provided with multiple modalities (web-based, mobile app, text, or paper and pencil) by which this can be accomplished. In specific, the proposed study will evaluate the feasibility of the trial design for an accessible, non-pharmacological, yoga-based intervention for chronic PCH pain among Veterans with mTBI, with the long-term goal of informing future efficacy trials.
- Conditions
- Traumatic Brain Injury, Post-concussive Headaches
- Being tested
- SAA-TBI
- Keywords
- Yoga, Veterans, Traumatic Brain Injury, Post-concussive Headaches, Post-concussive Symptoms
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAA-TBIBehavioural
Yoga twice a week for 75 minutes for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| YOGA-NOW | Experimental | Participant will start the SAA-TBI (yoga) about 2 weeks (+/- 2 weeks) after Study Visit 3. Receives: Behavioral: SAA-TBI |
| YOGA-WAIT | Active comparator | Participant will start SAA-TBI (yoga) about 10 weeks (+/- 2 weeks) after Study Visit 3. Receives: Behavioral: SAA-TBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headaches per week
Headache Tracking Form (HTF) will query about daily headache frequency, duration, severity, and treatment per event.
Measured: Change from baseline to approximately 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start16 Aug 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Crossover
- Model description
- Participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
- Investigators
- Lisa A Brenner, PhD, Principal investigator, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277859
- Sponsor's protocol ID
- 17-0785
- Acronym
- SAA-TBI
- Status last verified
- Jul 2019
- First submitted
- 7 Sep 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
- ClinicalTrials.gov ID
- NCT03277859
- Acronym / sponsor ID
- SAA-TBI / 17-0785
- Conditions
- Traumatic Brain Injury, Post-concussive Headaches
- Keywords
- Yoga, Veterans, Traumatic Brain Injury, Post-concussive Headaches, Post-concussive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- University of Colorado, Denver
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 11 Sep 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.
The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated.
Detailed description
A signature injury being sustained by Veterans from recent conflicts is mild traumatic brain injury (mTBI). For some, this condition is associated with multiple disabling post-concussive symptoms, including post-concussive headaches (PCH). PCHs are notoriously resistant to medication alone, and are associated with increased muscle tension, avoidance of physical activities, and anxiety related to having chronic pain. In this study, the feasibility (ease of implementation) of the design elements of an interventional trial of Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) will be explored. Yoga is operationalized as a practice involving physical postures, breath awareness, breathing exercises and mindfulness meditation. It is conceptualized as having three "active ingredients" (i.e., regulation of the autonomic nervous system via physical activity/breathing exercises, release of muscular tension associated with headaches, and mindfulness/acceptance). The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of an SAA-TBI intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated. Project aims will be evaluated using an experimental design where participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU). The participants in the waitlist condition will be offered SAA-TBI, after the initial group has completed the intervention. Both groups of participants will complete multiple measures at baseline and after the conclusion of the intervention. Maintenance among the intervention group will also be explored. Participants will be asked to complete daily homework documenting their headaches and yoga practice outside of class, and be provided with multiple modalities (web-based, mobile app, text, or paper and pencil) by which this can be accomplished. In specific, the proposed study will evaluate the feasibility of the trial design for an accessible, non-pharmacological, yoga-based intervention for chronic PCH pain among Veterans with mTBI, with the long-term goal of informing future efficacy trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU).
| Arm | Type | Receives |
|---|---|---|
| YOGA-NOW | Experimental | Behavioral: SAA-TBIParticipant will start the SAA-TBI (yoga) about 2 weeks (+/- 2 weeks) after Study Visit 3. |
| YOGA-WAIT | Active comparator | Behavioral: SAA-TBIParticipant will start SAA-TBI (yoga) about 10 weeks (+/- 2 weeks) after Study Visit 3. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and 55
- Able to provide informed consent
- History of mTBI per the Ohio State University TBI-ID (OSU-TBI-ID)
- History of PCH pain (TTH, migraine, or mixed), with onset of pain or increase in previous headache pain having occurred within one month of mTBI as determined by structured examination using criteria outlined in the International Classification of Headache Disorders-3 beta (ICHD-3 beta)
- Duration of PCH pain being greater than one year as determined by structured medical examination
Key exclusion criteria (8 listed)
- Younger than 18, or older than 55 years of age
- Active substance dependence, excluding Cannabis dependence (based on local issues regarding the legality of cannabis), as determined by structured clinical interview
- Moderate to severe TBI as determined per the OSU-TBI-ID
- Identification of active psychosis as determined by structured clinical interview
- Failing to receive medical clearance by study provider;
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 |
|---|---|---|
| SAA-TBIYoga twice a week for 75 minutes for 8 weeks | Behavioural | YOGA-NOW, YOGA-WAIT |
Primary outcome
Headaches per week
Time frame: Change from baseline to approximately 20 weeks
Headache Tracking Form (HTF) will query about daily headache frequency, duration, severity, and treatment per event.
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 23 Jul 2019.
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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.
Lisa A Brenner, PhD principal investigator
VA Eastern Colorado Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAA-TBI in people with Traumatic Brain Injury and Post-concussive Headaches, run by VA Eastern Colorado Health Care System 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 8 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 23 Jul 2019. 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?
Headaches per week (time frame: Change from baseline to approximately 20 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 23 Jul 2019.