Clinical trial NCT04708522: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Concussion Syndrome
Anxiety Disorders and Symptoms
Depressive Symptoms
Keywords: Breath control
Mindfulness
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Start of recruitment and end of recruitment (approximately 4 months from initiation of study)
measure: Feasibility of completion
timeFrame: Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)
measure: Feasibility of compliance
timeFrame: Start of study participation at baseline and end of study participation at completion of study (approximately 6 months from initiation of study)
measure: Feasibility of delivery
timeFrame: Start of recruitment and end of study (approximately 6 months from initiation of study)
measure: Acceptability of intervention
timeFrame: Assessed at conclusion of 8-week intervention participation for duration of study
measure: Effectiveness of intervention (PHQ-9)
timeFrame: Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study
measure: Effectiveness of intervention (GAD-7)
timeFrame: Assessed at baseline, at the end of weeks 2, 4, 6, and 8 throughout intervention participation for duration of study
measure: Effectiveness of intervention (RPQ)
timeFrame: Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation
measure: Effectiveness of intervention (PANAS)
timeFrame: Assessed at baseline, at the end of weeks 1, 2, 3, 4, 5, 6, 7 and 8 throughout intervention participation
Secondary outcomes:
measure: Participant demographic data
timeFrame: Baseline
measure: Concussion history data
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
Study officials:
affiliation: Western University
name: James P Dickey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.