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

Western University, Canada

Status: Unknown

Conditions: Depressive Symptoms; Anxiety Disorders and Symptoms; Post-Concussion Syndrome

Treatments: Behavioral: Guided Mindfulness Exercise; Behavioral: Breath Control - Equal Breathing Technique; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04708522

118148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Breath Control

Experimental group

Description:

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.

Treatment:

Behavioral: Breath Control - Equal Breathing Technique

Guided Mindfulness

Experimental group

Description:

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.

Treatment:

Behavioral: Guided Mindfulness Exercise

Control

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Control