Breath Control and Mindfulness for Post Concussion Anxiety and Depression: a Feasibility Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This study will assess the feasibility of a randomized control study designed to remotely deliver a breath control and guided mindfulness exercise to individuals experiencing post-concussion symptoms of anxiety or depression. Participants will be randomized into one of the study arms after they have met eligibility criteria and have given informed consent. Study arm interventions include a 20-minute paced breathing (breath control) exercise, a 20-minute guided mindfulness exercise, and a sham control arm that incorporates a minimal instruction 20-minute quiet sitting meditation exercise. The participant is asked to complete their assigned intervention daily for a period of eight weeks and to complete weekly and biweekly follow-up questionnaires. The questionnaires will include the Rivermead Post-Concussion Syndrome Questionnaire (RPQ) and the Positive Affect Negative Affect Survey Short Form (PANAS) completed weekly, the General Anxiety and Depression questionnaire (GAD-7) and the Patient Health Questionnaire (PHQ-9) completed biweekly. These questionnaires will be completed prior to a participant commencing the study (pre-test measure), at weekly intervals throughout the study (at end of week), and at the conclusion of the 8-week study (post-test measure). At the conclusion of the study participants will be asked to complete the Treatment Acceptability / Adherence Scale (TAAS), a measure used to assess the acceptability of the intervention from the point of view of the participant. All participant outcome measures, and intervention tracking questionnaires will be administered through a secure internet user-input interface.

Official Title
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Remote Delivery of a Brief Self-guided Breath Control and Mindfulness Exercise for the Treatment of Post-concussion Anxiety and Depression Symptoms: The Feasibility of a Randomized Control Trial

Conditions
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Post-Concussion Syndrome, Anxiety Disorders and Symptoms, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Breath Control - Equal Breathing Technique
* Behavioral: Guided Mindfulness Exercise
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages ≥18 to ≤65 years of age Males and females Ability to comprehend English (written and spoken) Physician-diagnosed concussion ≥ 4weeks prior to commencing study Experiencing post-concussion symptoms (>0 on the RPQ) Experiencing symptoms of anxiety and/or depression (Score ≥ 5 on the GAD-7 or ≥ 5 on the PHQ-9) Access to an internet accessible device (e.g., computer, smart phone or tablet) Access to a smart device (iOS or Android) (required for use of Awesome Breathing application) Exclusion Criteria: <18 or >65 years of age Score < 5 on the GAD-7 or < 5 on the PHQ-9 Score 0 on RPQ Inability to comprehend English (written and/or spoken) History of cardiovascular or cardiorespiratory condition History of non-traumatic acquired brain injury History of neurological or neurodevelopment disorder History of unmanaged or managed psychiatric diagnosis (i.e., mental health issue, including bipolar, schizophrenia, etc.) No history substance abuse (drug or alcohol) Current pregnancy Currently attending other yogic or meditation/mindfulness therapy sessions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breath Control<br>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. | Behavioral: Breath Control - Equal Breathing Technique<br>* The equal breathing (EB) exercise also known as square or box breathing will follow the four-part breathing cycle of inhalation, hold, exhalation, hold, repeat. Each part of the cycle will be a 4 second count repeated for 20 minutes.<br>|
| Experimental: Guided Mindfulness<br>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. | Behavioral: Guided Mindfulness Exercise<br>* The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.<br>|
| Sham Comparator: Control<br>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. | Behavioral: Control<br>* The control intervention will utilize a sham exercise. The participant will be asked to rest in a comfortable seated position for the duration of the 20 minute session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment | Proportion of screened individuals choosing to participate (and reasons for not participating) | Start of recruitment and end of recruitment (approximately 4 months from initiation of study) | 
| Feasibility of completion | Proportion of participants who drop-out prior to program completion | Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study) | 
| Feasibility of compliance | Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys | Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study) | 
| Feasibility of delivery | Investigator time-cost analysis of intervention delivery (investigator time/participant) | Start of recruitment and end of study (approximately 6 months from initiation of study) | 
| Acceptability of intervention | Evaluated using Treatment Acceptability/Adherence Scale - individual item mean score of 10 item questionnaire each ranging from 1 (strongly disagree) to 7 (agree strongly) | Assessed at conclusion of 8-week intervention participation for duration of study | 
| Effectiveness of intervention (PHQ-9) | Change in participant outcome measures (questionnaires) for all treatment arms: Change in depressive symptoms measured by PHQ-9 - total score ranges from 0 (no symptoms) to 27 (severe symptoms) for all treatment arms | Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study | 
| Effectiveness of intervention (GAD-7) | Change in participant outcome measures (questionnaires) for all treatment arms: Change in anxiety symptoms measured by GAD-7 - total score ranges from 0 (no symptoms) to 21 (severe symptoms) for all treatment arms | Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study | 
| Effectiveness of intervention (RPQ) | Change in participant outcome measures (questionnaires) for all treatment arms: Change in post-concussion symptoms measured by RPQ - total score ranges from 0 (not experienced) to 64 (severe problem) for all treatment arms | Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation | 
| Effectiveness of intervention (PANAS) | Change in participant outcome measures (questionnaires) for all treatment arms: Change in positive and negative affect measured by PANAS - total score ranges from 10 (lower) to 50 (higher) for each of positive affect and negative affect for all treatment arms | Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant demographic data | Participant demographic data will be used to describe participant volunteers to inform sample population characteristics. | Baseline | 
| Concussion history data | Participant concussion history will provide descriptive analysis of mechanism of injury, number of concussions, characteristics of current concussion injury (time since injury, hospitalization due to injury) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breath control, Mindfulness