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Breath Control for Post-Concussion Syndrome

N/A
Waitlist Available
Led By James P Dickey, PhD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages ≥18 to ≤65 years of age
Males and females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of recruitment and end of study (approximately 6 months from initiation of study)
Awards & highlights

Study Summary

Persistent-post-concussion symptoms (PPCS) is a condition that effects on average one in seven persons following a concussion. Anxiety and depression symptoms are experienced by over one-third of those with PPCS. These symptoms can delay recovery from a concussion. Two techniques used to treat anxiety and depression symptoms are breath control and mindfulness exercises. This 8-week feasibility study will evaluate the implementation and compliance of a remote delivered breathing and mindfulness treatment program for individuals experiencing PPCS anxiety or depression symptoms.

Eligible Conditions
  • Post-Concussion Syndrome
  • Anxiety Disorders
  • Depression

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of recruitment and end of study (approximately 6 months from initiation of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of recruitment and end of study (approximately 6 months from initiation of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of intervention
Effectiveness of intervention (GAD-7)
Effectiveness of intervention (PANAS)
+6 more
Secondary outcome measures
Concussion history data
Participant demographic data

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Guided MindfulnessExperimental Treatment1 Intervention
Participants in the guided mindfulness study arm will be lead through a seated mindfulness exercise. This intervention exercise will be completed daily for a period of 8 weeks.
Group II: Breath ControlExperimental Treatment1 Intervention
Participants in the breath control study arm will be given a breathing exercise that is to be completed in a comfortable upright seated posture. This intervention exercise will be completed daily for a period of 8 weeks.
Group III: ControlPlacebo Group1 Intervention
Participants in the control group will receive a sham intervention. The sham intervention will involve minimal instructed meditation exercise. This intervention exercise will be completed daily for a period of 8 weeks.

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Who is running the clinical trial?

Western University, CanadaLead Sponsor
238 Previous Clinical Trials
57,152 Total Patients Enrolled
3 Trials studying Post-Concussion Syndrome
640 Patients Enrolled for Post-Concussion Syndrome
James P Dickey, PhDPrincipal InvestigatorWestern University
2 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Post-Concussion Syndrome
31 Patients Enrolled for Post-Concussion Syndrome

Frequently Asked Questions

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~7 spots leftby Mar 2025