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

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04708522
• Other study ID #: 118148
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: July 2021

Study information

• Verified date: November 2020
• Source: Western University, Canada
• Contact: James P Dickey, PhD
• Phone: 5196612111
• Email: jdickey[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Disorders and Symptoms
• Depression
• Depressive Symptoms
• Post-Concussion Syndrome

Intervention

Behavioral:
• 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.
• Guided Mindfulness Exercise
The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.
• 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.

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Eyres S, Carey A, Gilworth G, Neumann V, Tennant A. Construct validity and reliability of the Rivermead Post-Concussion Symptoms Questionnaire. Clin Rehabil. 2005 Dec;19(8):878-87. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Participant demographic data	Participant demographic data will be used to describe participant volunteers to inform sample population characteristics.	Baseline
Secondary	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