Post Concussion SyndromePhase 1/2NCT00871884
Evaluation of Two Treatments for Chronic Post Concussion Syndrome
A Phase 1/2 study testing Psychoeducation, Relaxation Training and Interoceptive Exposure in people with Post Concussion Syndrome and Head Injury, run by Simon Fraser University at 1 site in Canada.
Trial summary
This study is designed to investigate factors that are associated with prolonged recovery from mild head injury. The investigators are particularly interested in defining the impact of anxiety related variables, such as health anxiety and anxiety sensitivity in the maintenance of symptoms. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Concussion Syndrome, Head Injury
- What is being tested?
- Psychoeducation, Relaxation Training and Interoceptive Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Jan 2014
- Phase
- Phase 1/2
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild Head Injury at least 3 months prior to treatment
- age 19 to 65 years
- grade 12 education
- proficiency with English language
Who cannot join
- Current Litigation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Psychology Centre, Simon Fraser University
Burnaby, British Columbia, V5A 1S6
About this study
Official title: The Role of Anxiety Sensitivity in the Maintenance of Chronic Post Concussion Symptoms
This study is designed to investigate factors that are associated with prolonged recovery from mild head injury. The investigators are particularly interested in defining the impact of anxiety related variables, such as health anxiety and anxiety sensitivity in the maintenance of symptoms.
A further goal of the study is the evaluation of two treatment methods that have been proposed to be effective in reducing the impact of post concussion symptoms. The investigators hypothesize that a treatment which is directly focused on changing these anxiety related variables will be more effective than one that does not.
- Conditions
- Post Concussion Syndrome, Head Injury
- Being tested
- Psychoeducation, Relaxation Training, Interoceptive Exposure
- Keywords
- Post Concussion Syndrome, Cognitive Behavioral Therapy, Anxiety Sensitivity, Mild Head Injury, Psychotherapy, Chronic Post Concussion Symptoms
- Medical subject headings
- Post-Concussion Syndrome, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Education about the common prognostic considerations, normal symptoms experienced and etiology of symptoms following mild head injury. Includes some basic suggestions surrounding methods to diminish the impact of symptoms on one's life.
Relaxation TrainingBehavioural
Includes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation.
Interoceptive ExposureBehavioural
Includes a variety of exercises used to elicit somatic sensations which may be feared by the participant, in an attempt to extinguish or lessen the fear reaction to these sensations.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | Active comparator | Not described Receives: Behavioral: Psychoeducation; Behavioral: Relaxation Training |
| Experimental | Experimental | Not described Receives: Behavioral: Psychoeducation; Behavioral: Relaxation Training; Behavioral: Interoceptive Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Concussion Symptom Checklist
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks
Secondary outcomes (3)
Anxiety Sensitivity Index
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks
State Trait Anxiety Inventory
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks
Zung Self Rated Depression Scale
Measured: 0 weeks, 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startApr 2008
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Poor enrollment, low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Concussion SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Whitfield, Simon Fraser University
- Investigators
- Kevin C Whitfield, M.A., Principal investigator, Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser UniversityAllen E Thornton, Ph.D., Study director, Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser UniversityAlex P Chapman, Ph.D., Study director, Department of Psychology, Simon fraser UniversityDavid Cox, Ph.D., Study director, Department of Psychology, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871884
- Sponsor's protocol ID
- 1234567
- Status last verified
- Jan 2014
- First submitted
- 27 Mar 2009
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Anxiety Sensitivity in the Maintenance of Chronic Post Concussion Symptoms
- ClinicalTrials.gov ID
- NCT00871884
- Acronym / sponsor ID
- 1234567
- Conditions
- Post Concussion Syndrome, Head Injury
- Keywords
- Post Concussion Syndrome, Cognitive Behavioral Therapy, Anxiety Sensitivity, Mild Head Injury, Psychotherapy, Chronic Post Concussion Symptoms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment, low recruitment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Mar 2009 (estimated)
- 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.
This study is designed to investigate factors that are associated with prolonged recovery from mild head injury. The investigators are particularly interested in defining the impact of anxiety related variables, such as health anxiety and anxiety sensitivity in the maintenance of symptoms.
A further goal of the study is the evaluation of two treatment methods that have been proposed to be effective in reducing the impact of post concussion symptoms. The investigators hypothesize that a treatment which is directly focused on changing these anxiety related variables will be more effective than one that does not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | Active comparator | Behavioral: Psychoeducation, Behavioral: Relaxation Training |
| Experimental | Experimental | Behavioral: Psychoeducation, Behavioral: Relaxation Training, Behavioral: Interoceptive Exposure |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mild Head Injury at least 3 months prior to treatment
- age 19 to 65 years
- grade 12 education
- proficiency with English language
Key exclusion criteria (1 listed)
- Current Litigation
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 |
|---|---|---|
| PsychoeducationEducation about the common prognostic considerations, normal symptoms experienced and etiology of symptoms following mild head injury. Includes some basic suggestions surrounding methods to diminish the impact of symptoms on one's life. | Behavioural | Experimental, Treatment As Usual |
| Relaxation TrainingIncludes Progressive Muscle Relaxation, Guided Visualization, and various other relaxation techniques to induce deep relaxation. | Behavioural | Experimental, Treatment As Usual |
| Interoceptive ExposureIncludes a variety of exercises used to elicit somatic sensations which may be feared by the participant, in an attempt to extinguish or lessen the fear reaction to these sensations. | Behavioural | Experimental |
Primary outcome
Post Concussion Symptom Checklist
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
3 secondary outcomes
Anxiety Sensitivity Index
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
State Trait Anxiety Inventory
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
Zung Self Rated Depression Scale
Time frame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
Results and safety
The study was stopped early (reason given: Poor enrollment, low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- study recruitment homepageLink provided by the sponsor.
Related trials for Post Concussion Syndrome
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Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
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Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
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Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
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.
Kevin C Whitfield, M.A. principal investigator
Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
Allen E Thornton, Ph.D. study director
Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
Alex P Chapman, Ph.D. study director
Department of Psychology, Simon fraser University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psychoeducation, Relaxation Training and Interoceptive Exposure in people with Post Concussion Syndrome and Head Injury, run by Simon Fraser University at 1 site in Canada.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Jan 2014. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment, low recruitment.). Results are not available in the source record.
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?
Post Concussion Symptom Checklist (time frame: 0 weeks, 2 weeks, 4 weeks, 6 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 22 Jan 2014.