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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Breath Control - Equal Breathing Technique
Guided Mindfulness Exercise
Control
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Breath control, Mindfulness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Breath Control

Guided Mindfulness

Control

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of recruitment
Proportion of screened individuals choosing to participate (and reasons for not participating)
Feasibility of completion
Proportion of participants who drop-out prior to program completion
Feasibility of compliance
Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys
Feasibility of delivery
Investigator time-cost analysis of intervention delivery (investigator time/participant)
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)
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
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
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
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

Secondary Outcome Measures

Participant demographic data
Participant demographic data will be used to describe participant volunteers to inform sample population characteristics.
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)

Full Information

First Posted
December 16, 2020
Last Updated
January 11, 2021
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04708522
Brief Title
Breath Control and Mindfulness for Post Concussion Anxiety and Depression: a Feasibility Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome, Anxiety Disorders and Symptoms, Depressive Symptoms
Keywords
Breath control, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breath Control
Arm Type
Experimental
Arm 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.
Arm Title
Guided Mindfulness
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Breath Control - Equal Breathing Technique
Intervention Description
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
Intervention Name(s)
Guided Mindfulness Exercise
Intervention Description
The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Proportion of screened individuals choosing to participate (and reasons for not participating)
Time Frame
Start of recruitment and end of recruitment (approximately 4 months from initiation of study)
Title
Feasibility of completion
Description
Proportion of participants who drop-out prior to program completion
Time Frame
Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)
Title
Feasibility of compliance
Description
Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys
Time Frame
Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)
Title
Feasibility of delivery
Description
Investigator time-cost analysis of intervention delivery (investigator time/participant)
Time Frame
Start of recruitment and end of study (approximately 6 months from initiation of study)
Title
Acceptability of intervention
Description
Evaluated using Treatment Acceptability/Adherence Scale - individual item mean score of 10 item questionnaire each ranging from 1 (strongly disagree) to 7 (agree strongly)
Time Frame
Assessed at conclusion of 8-week intervention participation for duration of study
Title
Effectiveness of intervention (PHQ-9)
Description
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
Time Frame
Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study
Title
Effectiveness of intervention (GAD-7)
Description
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
Time Frame
Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study
Title
Effectiveness of intervention (RPQ)
Description
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
Time Frame
Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation
Title
Effectiveness of intervention (PANAS)
Description
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
Time Frame
Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation
Secondary Outcome Measure Information:
Title
Participant demographic data
Description
Participant demographic data will be used to describe participant volunteers to inform sample population characteristics.
Time Frame
Baseline
Title
Concussion history data
Description
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)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James P Dickey, PhD
Phone
5196612111
Ext
87834
Email
jdickey@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
William N Campbell, MSc
Phone
2263389876
Email
wcampb23@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P Dickey, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A3K7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James P Dickey, PhD
Phone
5196612111
Ext
87834
Email
jdickey@uwo.ca

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Each participant will be identified with a code based on study protocol, testing year and participant number (e.g., SP#YYPID#: SP#201001) that correlates to his or her addition to the study. The master reference that contains the decoding system will be stored on a secure server behind fire wall protection. All other data will be labeled using the participant's identification code.
Citations:
PubMed Identifier
26091250
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.
Results Reference
background
PubMed Identifier
16323387
Citation
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. doi: 10.1191/0269215505cr905oa.
Results Reference
background
PubMed Identifier
11556941
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. doi: 10.1046/j.1525-1497.2001.016009606.x.
Results Reference
background
PubMed Identifier
3397865
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. doi: 10.1037//0022-3514.54.6.1063.
Results Reference
background
PubMed Identifier
16717171
Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Results Reference
background

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

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