Post-Concussion SyndromeNCT04708522
Breath Control and Mindfulness for Post Concussion Anxiety and Depression: a Feasibility Study
A study testing Guided Mindfulness Exercise in people with Post-Concussion Syndrome and Anxiety Disorders and Symptoms, run by Western University, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Concussion Syndrome, Anxiety Disorders and Symptoms, Depressive Symptoms
- What is being tested?
- Guided Mindfulness Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2021to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- <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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site
University of Western Ontario
London, Ontario, N6A3K7
James P Dickey, PhD, 5196612111 ext. 87834, jdickey@uwo.ca
About this 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
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.
Read the 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.
- Being tested
- Breath Control - Equal Breathing Technique, Guided Mindfulness Exercise, Control
- Keywords
- Breath control, Mindfulness
- Medical subject headings
- Post-Concussion Syndrome, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Control - Equal Breathing TechniqueBehavioural
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 ExerciseBehavioural
The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Breath Control | Experimental | 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. Receives: Behavioral: Breath Control - Equal Breathing Technique |
| Guided Mindfulness | Experimental | 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. Receives: Behavioral: Guided Mindfulness Exercise |
| Control | Sham comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Proportion of screened individuals choosing to participate (and reasons for not participating)
Measured: Start of recruitment and end of recruitment (approximately 4 months from initiation of study)
Feasibility of completion
Proportion of participants who drop-out prior to program completion
Measured: Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)
Feasibility of compliance
Proportion of program sessions attended (and reasons for non-attendance); proportion of participants that complete surveys
Measured: Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)
Feasibility of delivery
Investigator time-cost analysis of intervention delivery (investigator time/participant)
Measured: Start of recruitment and end of study (approximately 6 months from initiation of study)
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)
Measured: Assessed at conclusion of 8-week intervention participation for duration of study
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
Measured: Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study
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
Measured: Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study
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
Measured: Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation
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
Measured: Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation
Secondary outcomes (2)
Participant demographic data
Participant demographic data will be used to describe participant volunteers to inform sample population characteristics.
Measured: Baseline
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James P Dickey, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708522
- Sponsor's protocol ID
- 118148
- Status last verified
- Nov 2020
- First submitted
- 16 Dec 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26091250Eyres 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.
PubMed 16323387Kroenke 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.
PubMed 11556941Watson 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.
PubMed 3397865Spitzer 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.
PubMed 16717171
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04708522
- Acronym / sponsor ID
- 118148
- Keywords
- Breath control, Mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breath Control | Experimental | Behavioral: Breath Control - Equal Breathing TechniqueParticipants 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 | Experimental | Behavioral: Guided Mindfulness ExerciseParticipants 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 | Sham comparator | Behavioral: ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath Control - Equal Breathing TechniqueThe 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. | Behavioural | Breath Control |
| Guided Mindfulness ExerciseThe guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording. | Behavioural | Guided Mindfulness |
| ControlThe 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. | Behavioural | Control |
Primary outcome
Feasibility of recruitment
Time frame: 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 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)
Proportion of participants who drop-out prior to program completion
Feasibility of compliance
Time frame: 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
Feasibility of delivery
Time frame: Start of recruitment and end of study (approximately 6 months from initiation of study)
Investigator time-cost analysis of intervention delivery (investigator time/participant)
Acceptability of intervention
Time frame: 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)
Time frame: 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 (GAD-7)
Time frame: 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
Effectiveness of intervention (RPQ)
Time frame: 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
Effectiveness of intervention (PANAS)
Time frame: 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
2 secondary outcomes
Participant demographic data
Time frame: Baseline
Concussion history data
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 26091250Milosevic 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.
- Background: PubMed 16323387Eyres 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.
- Background: PubMed 11556941Kroenke 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.
- Background: PubMed 3397865Watson 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.
- Background: PubMed 16717171Spitzer 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P Dickey, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Mindfulness Exercise in people with Post-Concussion Syndrome and Anxiety Disorders and Symptoms, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James P Dickey, PhD (5196612111 ext. 87834, jdickey@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Start of recruitment and end of recruitment (approximately 4 months from initiation of study)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04708522, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.