- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277859
Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) (SAA-TBI)
July 22, 2019 updated by: Lisa Brenner, VA Eastern Colorado Health Care System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Rocky Mountain Regional VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YOGA-NOW
Participant will start the SAA-TBI (yoga) about 2 weeks (+/- 2 weeks) after Study Visit 3.
|
Yoga twice a week for 75 minutes for 8 weeks
|
Active Comparator: YOGA-WAIT
Participant will start SAA-TBI (yoga) about 10 weeks (+/- 2 weeks) after Study Visit 3.
|
Yoga twice a week for 75 minutes for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline to approximately 20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lisa A Brenner, PhD, VA Eastern Colorado Health Care System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2017
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
June 30, 2019
Study Registration Dates
First Submitted
September 7, 2017
First Submitted That Met QC Criteria
September 7, 2017
First Posted (Actual)
September 11, 2017
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0785
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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