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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: YOGA-NOW
Participant will start the SAA-TBI (yoga) about 2 weeks (+/- 2 weeks) after Study Visit 3.
Behavioral: SAA-TBI
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.
Behavioral: SAA-TBI
Yoga twice a week for 75 minutes for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Eastern Colorado Health Care System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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