Sports InjuryNCT03849170
Reducing Competitive Anxiety Cheerleader Psychology
A study testing Stress Inoculation Technique and Health Intervention in people with Sports Injury and Stress Reaction, run by Western University, Canada.
Trial summary
Cheer leading is a rapidly growing international sport known for its acrobatic skills and dangerous stunts. The sport presents ample risk for physical trauma, and it is common for athletes to miss extensive time from cheer leading due to injury. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sports Injury, Stress Reaction, Performance Anxiety
- What is being tested?
- Stress Inoculation Technique and Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants must be active members of Western University's coed cheerleading team for the 2019 competitive season (August-November 2019)
- Participants must be on Western University's coed cheerleading team during the 2019 PCA College National Championships
- Participants must have no experience with psychological stress-management interventions aimed at reducing competitive sport anxiety, in particular, no previous experience with Stress Inoculation Technique therapy.
Who cannot join
- Not being an active member of Western University's coed cheerleading team for the beginning of the 2019 competitive season (September 2019), whether due to injury or absence from the team.
- Not being an active member of Western University's coed cheerleading team during the 2019 PCA College National Championships
- Previous experience with psychological stress-management interventions aimed at reducing competitive sport anxiety in a cheerleading context, in particular, previous experience with Stress Inoculation Technique therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reducing Competitive Anxiety in Cheerleaders: A Psychological Approach
Cheer leading is a rapidly growing international sport known for its acrobatic skills and dangerous stunts. The sport presents ample risk for physical trauma, and it is common for athletes to miss extensive time from cheer leading due to injury. The goal of this study is to the see whether the investigators can reduce injury risk among cheer leading athletes by teaching them stress-coping skills to help them relax and reduce their sport-related stress. There exists a link between high levels of stress and increased rates of injury among athletes. When individuals become stressed during athletic events such as competitions or strenuous training, symptoms including muscle tension and narrowed attention often accompany the stress response, increasing injury risk and reducing performance quality. In this study, half of Western University's coed cheer leading team will participate in a six-session stress management intervention to teach them relevant psychological stress-coping skills. Such skills include relaxation breathing techniques, visualization exercises, stoppage of negative thoughts, and development of self-efficacy statements. The other half of the team will receive a placebo "sport nutrition" program. The sessions of both the control program and the stress-management intervention will be administered over the most intensive period of the cheer leading season, from September to November of 2019. The investigators predict that the intervention group athletes will report less cheer leading time missed due to injury, report less sport-related stress, and make fewer errors at their cheer leading championship than their teammates in the placebo group. This is the first study to administer a psychological injury-prevention intervention to cheerleaders.
Read the detailed description
Background Information: Cheer leading is a growing, highly competitive, and potentially stressful sport, with 3.5 million athletes practicing worldwide. The sport presents many risks, as it was responsible for more catastrophic injuries among female high school and college athletes than any other sport between 1982 and 2016 in the U.S. In Canada, there were 1496 cheer leading injuries requiring hospitalization from 1990 to 2010. According to the Williams and Andersen stress model, athletes with certain personality dispositions (e.g. high competitive anxiety), fewer coping resources (e.g. social support, stress management) and an extensive history of life stressors are prone to appraising athletic situations as being stressful, resulting in an exaggerated stress response. The stress response is particularly likely to manifest itself during instances in which an athlete perceives a high demand to succeed, but feels they possess inadequate resources to do so. These situations often lead to a variety of symptoms, including poorer performance quality, generalized muscle tension (physiological), and heightened distractibility (attentional), culminating in a greater likelihood of injury among athletes. Objectives: The goal of this study will be to administer a psychological-based intervention to improve the stress-coping skills of competitive cheerleaders, acting to minimize their competitive anxiety, maintain their performance quality, and reduce their risk of injury during the span of a season. Hypothesis: Cheerleaders who complete a psychological-based stress-coping intervention will report lower competitive anxiety, demonstrate superior performance, and report less time lost from cheer leading due to injury compared to a control group of teammates receiving a placebo program. Theoretical Approach: The psychological intervention will be based on the Stress Inoculation Technique (SIT), with the objective of restructuring athletes' coping skills in order to improve their management of stress (i.e. competitive anxiety). During the first phase of SIT, athletes will bring up narrative accounts of stressful athletic situations, identifying previously insufficient coping techniques as well as potential coping strengths. Self-monitoring strategies will be introduced to help athletes become more aware of the ways that they inadvertently build up stress reactions. During the second SIT phase, athletes will be taught coping skills such as muscle relaxation, use of self-efficacy (confidence) statements, cognitive re-framing of stressful situations, and emotion regulation techniques, which they will then apply to their personal cheer leading experiences. These skills will be further rehearsed through positive mental imagery and practice to ensure their effectiveness. In the final SIT stage, athletes will be encouraged to apply their new coping skills to incrementally more demanding cheer leading situations while utilizing stress management techniques. Athletes will be further reminded to take credit for their improvement, instilling a lasting sense of self-efficacy. The SIT intervention will teach athletes an array of anxiety management skills in order to help them develop effective stress-coping strategies during important cheer leading events. Participants will maintain an in-person correspondence with the researcher throughout to ensure a properly personalized and collaborative intervention experience. Methods: The intervention period will reach from September 2019 to December 2019, as this is the busiest and most competitive part of the cheer leading season. Half of Western University's 30-40 athlete co-ed cheer leading team will be randomized to complete a six session "sport nutrition" program as a control, while the other half will be randomized to complete a six session bi-weekly SIT program. Since the intervention and control groups will come from the same team, all participants will share identical practice and competition schedules, ensuring each group is exposed to the same athletic situations. As such, differences in group outcomes will most likely be due to the type of intervention they received. To measure performance quality, total scoring deductions caused by the athletes in each group during Western's two runs at the 2019 PCA college cheer leading championship will be compared. Fewer deductions indicate fewer errors (bobbles, drops, falls, etc.) and reflect superior performance. Impact: The current study will be the first to develop and implement a psychological-based intervention tailored to cheerleaders with the goal of improving these athletes' stress-coping abilities. If successful, this intervention is highly scalable and can be used by athletes where stress and injury are salient features of their sport, and where individual performance is highly scrutinized.
- Conditions
- Sports Injury, Stress Reaction, Performance Anxiety
- Being tested
- Stress Inoculation Technique, Health Intervention
- Keywords
- cheerleading, stress management, injury prevention, psychosocial factors, stress-injury, performance, coping skills, stress inoculation technique, competitive anxiety, psychological intervention
- Medical subject headings
- Athletic Injuries, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Inoculation TechniqueBehavioural
Teaches athletes to use cognitive-behavioral techniques to reduce their stress response during sporting events.
Health InterventionOther
Will provide basic dietary and lifestyle guidelines that athletes should follow in their daily lives to maintain their health
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | Six session intervention, each session 20-25 minutes in length. Stress inoculation technique-based intervention. Participants will be taught stress coping skills and relaxation skills such as self-efficacy statements, imagery, relaxation breathing, relaxation scripts, thought stoppage, cognitive reframing, positive self-talk, goal setting, event planning, and preparing for competition Receives: Behavioral: Stress Inoculation Technique |
| Health Intervention | Placebo comparator | Six session intervention, each session 20-25 minutes in length. Participants will be taught relevant health and nutrition guidelines and practice using a food diary app (MyFitnessPal). Nutrition and health content will include such topics as reading Canadian food labels, vitamins and supplements, effects of alcohol on performance and recovery, vegetarian vs. omnivore diets, and hydration \& performance. Receives: Other: Health Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury Time
The amount of cheerleading time participants must modify or miss due to injuries suffered due to cheerleading. This outcome will be self-reported by each participant throughout the time frame using an injury data sheet provided to them by the investigators.
Measured: 14 weeks
Incidences of Injury
The number of cheerleading injuries sustained by the participants during the study period. This outcome will be self-reported by each participant throughout the time frame using an injury data sheet provided to them by the investigators.
Measured: 14 weeks
Secondary outcomes (2)
Sport Anxiety
The amount of anxiety and stress participants report feeling as a result of the demands of training and competing for their cheerleading team. This outcome will be measured based on each participant's score on the Sport Anxiety Scale-2 (SAS-2). Each participant's post-test score on this measure will be compared to the participant's baseline score. There are fifteen questions, with five questions per subscale: somatic symptoms, concentration disruption, and worry. Each question asks participants how often they experience worry, concentration disruption, or somatic symptoms, with a low score of 1 indicating "not at all" and a high score of 4 indicating "very much". Total score on the questionnaire ranges from 15 to 60. A low total score indicates lower sports anxiety, and a higher scores indicates intense feelings of worry, disruption of concentration, and somatic symptoms.
Measured: First at baseline, then again 14 weeks later.
Stress Coping Resources
The amount of stress coping techniques and skills participants employ in order to deal with their sport anxiety during important sporting events. This outcome will be measured based on each participant's score on the Athletic Coping Skills Inventory-28 (ACSI-28). Each participant's post-test score on this measure will be compared to the participant's baseline score. There are 28 questions, and seven subscales: coping with adversity, coachability, concentration, confidence and achievement motivation, goal-setting and mental preparation, peaking under pressure, and freedom from worry. Scores range from a low of 0 to a high of 12 on each subscale, with higher scores indicating greater strengths on that subscale. The score for the total scale ranges from a low of 0 to a high of 84, with higher scores signifying greater strength.
Measured: First at baseline, then again 14 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study startAug 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sports InjuryStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Independent, randomized groups, longitudinal study
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry Prapavessis, Ph.D, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849170
- Sponsor's protocol ID
- 113455
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meichenbaum, D. H., & Deffenbacher, J. L. (1988). Stress Inoculation Training. The Counseling Psychologist, 16(1), 69-90.
Williams, J. M., & Andersen, M. B. (1998). Psychosocial Antecedents of Sport Injury: Review and Critique of the Stress and Injury Model. Journal of Applied Sport Psychology, 10, 5-25.
Smith, R. E., Schutz, R. W., Smoll, F. L., & Ptacek, J. T. (1995). Development and Validation of a Multidimensional Measure of Sport-Specific Psychological Skills: The Athletic Coping Skills Inventory-28. Journal of Sport and Exercise Psychology, 17, 379-398.
Smith, R. E., Smoll, F. L., Cumming, S. P., & Grossbard, J. R. (2006). Measurement of Multidimensional Sport Performance Anxiety in Children and Adults: The Sport Anxiety Scale-2. Journal of Sport & Exercise Psychology, 28, 479-501.
Hardy I, McFaull S, Saint-Vil D. Neck and spine injuries in Canadian cheerleaders: An increasing trend. J Pediatr Surg. 2015 May;50(5):790-2. doi: 10.1016/j.jpedsurg.2015.02.039. Epub 2015 Feb 19.
PubMed 25783366Kucera, K. L., Thomas, L. C., Cantu, R. C. (2017). Catastrophic Sports Injury Research, Thirty-Fourth Annual Report, Fall 1982 - Spring 2016. Chapel Hill, NC.
Kolt GS, Hume PA, Smith P, Williams MM. Effects of a stress-management program on injury and stress of competitive gymnasts. Percept Mot Skills. 2004 Aug;99(1):195-207. doi: 10.2466/pms.99.1.195-207.
PubMed 15446646Maddison, R., & Prapavessis, H. (2005). A Psychological Approach to the Prediction and Prevention of Athletic Injury. Journal of Sport and Exercise Psychology, 27, 289- 310.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Competitive Anxiety in Cheerleaders: A Psychological Approach
- ClinicalTrials.gov ID
- NCT03849170
- Acronym / sponsor ID
- 113455
- Conditions
- Sports Injury, Stress Reaction, Performance Anxiety
- Keywords
- cheerleading, stress management, injury prevention, psychosocial factors, stress-injury, performance, coping skills, stress inoculation technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Feb 2019 (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.
Cheer leading is a rapidly growing international sport known for its acrobatic skills and dangerous stunts. The sport presents ample risk for physical trauma, and it is common for athletes to miss extensive time from cheer leading due to injury. The goal of this study is to the see whether the investigators can reduce injury risk among cheer leading athletes by teaching them stress-coping skills to help them relax and reduce their sport-related stress. There exists a link between high levels of stress and increased rates of injury among athletes. When individuals become stressed during athletic events such as competitions or strenuous training, symptoms including muscle tension and narrowed attention often accompany the stress response, increasing injury risk and reducing performance quality. In this study, half of Western University's coed cheer leading team will participate in a six-session stress management intervention to teach them relevant psychological stress-coping skills. Such skills include relaxation breathing techniques, visualization exercises, stoppage of negative thoughts, and development of self-efficacy statements. The other half of the team will receive a placebo "sport nutrition" program. The sessions of both the control program and the stress-management intervention will be administered over the most intensive period of the cheer leading season, from September to November of 2019. The investigators predict that the intervention group athletes will report less cheer leading time missed due to injury, report less sport-related stress, and make fewer errors at their cheer leading championship than their teammates in the placebo group. This is the first study to administer a psychological injury-prevention intervention to cheerleaders.
Detailed description
Background Information: Cheer leading is a growing, highly competitive, and potentially stressful sport, with 3.5 million athletes practicing worldwide. The sport presents many risks, as it was responsible for more catastrophic injuries among female high school and college athletes than any other sport between 1982 and 2016 in the U.S. In Canada, there were 1496 cheer leading injuries requiring hospitalization from 1990 to 2010. According to the Williams and Andersen stress model, athletes with certain personality dispositions (e.g. high competitive anxiety), fewer coping resources (e.g. social support, stress management) and an extensive history of life stressors are prone to appraising athletic situations as being stressful, resulting in an exaggerated stress response. The stress response is particularly likely to manifest itself during instances in which an athlete perceives a high demand to succeed, but feels they possess inadequate resources to do so. These situations often lead to a variety of symptoms, including poorer performance quality, generalized muscle tension (physiological), and heightened distractibility (attentional), culminating in a greater likelihood of injury among athletes. Objectives: The goal of this study will be to administer a psychological-based intervention to improve the stress-coping skills of competitive cheerleaders, acting to minimize their competitive anxiety, maintain their performance quality, and reduce their risk of injury during the span of a season. Hypothesis: Cheerleaders who complete a psychological-based stress-coping intervention will report lower competitive anxiety, demonstrate superior performance, and report less time lost from cheer leading due to injury compared to a control group of teammates receiving a placebo program. Theoretical Approach: The psychological intervention will be based on the Stress Inoculation Technique (SIT), with the objective of restructuring athletes' coping skills in order to improve their management of stress (i.e. competitive anxiety). During the first phase of SIT, athletes will bring up narrative accounts of stressful athletic situations, identifying previously insufficient coping techniques as well as potential coping strengths. Self-monitoring strategies will be introduced to help athletes become more aware of the ways that they inadvertently build up stress reactions. During the second SIT phase, athletes will be taught coping skills such as muscle relaxation, use of self-efficacy (confidence) statements, cognitive re-framing of stressful situations, and emotion regulation techniques, which they will then apply to their personal cheer leading experiences. These skills will be further rehearsed through positive mental imagery and practice to ensure their effectiveness. In the final SIT stage, athletes will be encouraged to apply their new coping skills to incrementally more demanding cheer leading situations while utilizing stress management techniques. Athletes will be further reminded to take credit for their improvement, instilling a lasting sense of self-efficacy. The SIT intervention will teach athletes an array of anxiety management skills in order to help them develop effective stress-coping strategies during important cheer leading events. Participants will maintain an in-person correspondence with the researcher throughout to ensure a properly personalized and collaborative intervention experience. Methods: The intervention period will reach from September 2019 to December 2019, as this is the busiest and most competitive part of the cheer leading season. Half of Western University's 30-40 athlete co-ed cheer leading team will be randomized to complete a six session "sport nutrition" program as a control, while the other half will be randomized to complete a six session bi-weekly SIT program. Since the intervention and control groups will come from the same team, all participants will share identical practice and competition schedules, ensuring each group is exposed to the same athletic situations. As such, differences in group outcomes will most likely be due to the type of intervention they received. To measure performance quality, total scoring deductions caused by the athletes in each group during Western's two runs at the 2019 PCA college cheer leading championship will be compared. Fewer deductions indicate fewer errors (bobbles, drops, falls, etc.) and reflect superior performance. Impact: The current study will be the first to develop and implement a psychological-based intervention tailored to cheerleaders with the goal of improving these athletes' stress-coping abilities. If successful, this intervention is highly scalable and can be used by athletes where stress and injury are salient features of their sport, and where individual performance is highly scrutinized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Independent, randomized groups, longitudinal study
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Behavioral: Stress Inoculation TechniqueSix session intervention, each session 20-25 minutes in length. Stress inoculation technique-based intervention. Participants will be taught stress coping skills and relaxation skills such as self-efficacy statements, imagery, relaxation breathing, relaxation scripts, thought stoppage, cognitive reframing, positive self-talk, goal setting, event planning, and preparing for competition |
| Health Intervention | Placebo comparator | Other: Health InterventionSix session intervention, each session 20-25 minutes in length. Participants will be taught relevant health and nutrition guidelines and practice using a food diary app (MyFitnessPal). Nutrition and health content will include such topics as reading Canadian food labels, vitamins and supplements, effects of alcohol on performance and recovery, vegetarian vs. omnivore diets, and hydration \& performance. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be active members of Western University's coed cheerleading team for the 2019 competitive season (August-November 2019)
- Participants must be on Western University's coed cheerleading team during the 2019 PCA College National Championships
- Participants must have no experience with psychological stress-management interventions aimed at reducing competitive sport anxiety, in particular, no previous experience with Stress Inoculation Technique therapy.
Key exclusion criteria (3 listed)
- Not being an active member of Western University's coed cheerleading team for the beginning of the 2019 competitive season (September 2019), whether due to injury or absence from the team.
- Not being an active member of Western University's coed cheerleading team during the 2019 PCA College National Championships
- Previous experience with psychological stress-management interventions aimed at reducing competitive sport anxiety in a cheerleading context, in particular, previous experience with Stress Inoculation Technique therapy.
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 |
|---|---|---|
| Stress Inoculation TechniqueTeaches athletes to use cognitive-behavioral techniques to reduce their stress response during sporting events. | Behavioural | Psychological Intervention |
| Health InterventionWill provide basic dietary and lifestyle guidelines that athletes should follow in their daily lives to maintain their health | Other | Health Intervention |
Primary outcome
Injury Time
Time frame: 14 weeks
The amount of cheerleading time participants must modify or miss due to injuries suffered due to cheerleading. This outcome will be self-reported by each participant throughout the time frame using an injury data sheet provided to them by the investigators.
Incidences of Injury
Time frame: 14 weeks
The number of cheerleading injuries sustained by the participants during the study period. This outcome will be self-reported by each participant throughout the time frame using an injury data sheet provided to them by the investigators.
2 secondary outcomes
Sport Anxiety
Time frame: First at baseline, then again 14 weeks later.
Stress Coping Resources
Time frame: First at baseline, then again 14 weeks later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- BackgroundMeichenbaum, D. H., & Deffenbacher, J. L. (1988). Stress Inoculation Training. The Counseling Psychologist, 16(1), 69-90.
- BackgroundWilliams, J. M., & Andersen, M. B. (1998). Psychosocial Antecedents of Sport Injury: Review and Critique of the Stress and Injury Model. Journal of Applied Sport Psychology, 10, 5-25.
- BackgroundSmith, R. E., Schutz, R. W., Smoll, F. L., & Ptacek, J. T. (1995). Development and Validation of a Multidimensional Measure of Sport-Specific Psychological Skills: The Athletic Coping Skills Inventory-28. Journal of Sport and Exercise Psychology, 17, 379-398.
- BackgroundSmith, R. E., Smoll, F. L., Cumming, S. P., & Grossbard, J. R. (2006). Measurement of Multidimensional Sport Performance Anxiety in Children and Adults: The Sport Anxiety Scale-2. Journal of Sport & Exercise Psychology, 28, 479-501.
- Background: PubMed 25783366Hardy I, McFaull S, Saint-Vil D. Neck and spine injuries in Canadian cheerleaders: An increasing trend. J Pediatr Surg. 2015 May;50(5):790-2. doi: 10.1016/j.jpedsurg.2015.02.039. Epub 2015 Feb 19.
- BackgroundKucera, K. L., Thomas, L. C., Cantu, R. C. (2017). Catastrophic Sports Injury Research, Thirty-Fourth Annual Report, Fall 1982 - Spring 2016. Chapel Hill, NC.
- Results publication: PubMed 15446646Kolt GS, Hume PA, Smith P, Williams MM. Effects of a stress-management program on injury and stress of competitive gymnasts. Percept Mot Skills. 2004 Aug;99(1):195-207. doi: 10.2466/pms.99.1.195-207.
- Results publicationMaddison, R., & Prapavessis, H. (2005). A Psychological Approach to the Prediction and Prevention of Athletic Injury. Journal of Sport and Exercise Psychology, 27, 289- 310.
- Individual participant dataSharing planned: No
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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.
Harry Prapavessis, Ph.D principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing Stress Inoculation Technique and Health Intervention in people with Sports Injury and Stress Reaction, run by Western University, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harry Prapavessis, Ph.D (5196612111 ext. 80173, Hprapave@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury Time (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849170, which also lists 8 linked publications.
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 7 Mar 2019.