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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-07-31

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.

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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.

Conditions

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Post-Concussion Syndrome Anxiety Disorders and Symptoms Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Breath Control

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 Type EXPERIMENTAL

Breath Control - Equal Breathing Technique

Intervention Type BEHAVIORAL

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.

Guided Mindfulness

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 Type EXPERIMENTAL

Guided Mindfulness Exercise

Intervention Type BEHAVIORAL

The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.

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.

Group Type SHAM_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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Breath Control - Equal Breathing Technique

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.

Intervention Type BEHAVIORAL

Guided Mindfulness Exercise

The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No