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

NCT04708522 | Unknown

• 1 other identifier: 118148
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Breath control; Mindfulness

Outcome Measures

Primary Outcomes (9)

• 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)

• 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)

• 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)

• 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)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Participant demographic data

  Baseline

• Concussion history data

  Baseline

Study Arms (3)

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.

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.

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.

Behavioral: Control

Interventions

Breath Control - Equal Breathing Technique BEHAVIORAL

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.

Breath Control

Guided Mindfulness Exercise BEHAVIORAL

The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.

Guided Mindfulness

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \<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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

University of Western Ontario

London, Ontario, N6A3K7, Canada

Location

Related Publications (5)

• 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.

  PMID: 26091250 BACKGROUND

• 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.

  PMID: 16323387 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 3397865 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

MeSH Terms

Conditions

Post-Concussion Syndrome; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• James P Dickey, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James P Dickey, PhD

CONTACT

5196612111; jdickey@uwo.ca

William N Campbell, MSc

CONTACT

2263389876; wcampb23@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 14, 2021
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)