Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708522
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2020-12-16
Brief Title:
Breath Control and Mindfulness for Post Concussion Anxiety and Depression a Feasibility Study
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None