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

Not Applicable

• Conditions: Post-Concussion Syndrome; Depressive Symptoms; Anxiety Disorders and Symptoms
• Interventions: Behavioral: Breath Control - Equal Breathing Technique; Behavioral: Guided Mindfulness Exercise; Behavioral: Control

• Registration Number: NCT04708522
• Lead Sponsor: Western University, Canada

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-12-16
• Study Start: 2021-01
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-14
• Primary Completion: 2021-05
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breath Control	Breath Control - Equal Breathing Technique	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.
Guided Mindfulness	Guided Mindfulness Exercise	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.
Control	Control	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment	Start of recruitment and end of recruitment (approximately 4 months from initiation of study)	Proportion of screened individuals choosing to participate (and reasons for not participating)
Feasibility of compliance	Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)	Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys
Effectiveness of intervention (RPQ)	Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation	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
Feasibility of delivery	Start of recruitment and end of study (approximately 6 months from initiation of study)	Investigator time-cost analysis of intervention delivery (investigator time/participant)
Effectiveness of intervention (GAD-7)	Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study	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
Acceptability of intervention	Assessed at conclusion of 8-week intervention participation for duration of study	Evaluated using Treatment Acceptability/Adherence Scale - individual item mean score of 10 item questionnaire each ranging from 1 (strongly disagree) to 7 (agree strongly)
Effectiveness of intervention (PHQ-9)	Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study	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
Effectiveness of intervention (PANAS)	Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation	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
Feasibility of completion	Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)	Proportion of participants who drop-out prior to program completion

Secondary Outcome Measures

Name	Time	Method
Participant demographic data	Baseline	Participant demographic data will be used to describe participant volunteers to inform sample population characteristics.
Concussion history data	Baseline	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)

Trial Locations

Locations (1)

University of Western Ontario; 🇨🇦 London, Ontario, Canada