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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •<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
结局指标
主要结局
Feasibility of recruitment
时间窗: 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 compliance
时间窗: 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
Effectiveness of intervention (RPQ)
时间窗: 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
Feasibility of delivery
时间窗: Start of recruitment and end of study (approximately 6 months from initiation of study)
Investigator time-cost analysis of intervention delivery (investigator time/participant)
Effectiveness of intervention (GAD-7)
时间窗: 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
Acceptability of intervention
时间窗: 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)
时间窗: 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 (PANAS)
时间窗: 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
Feasibility of completion
时间窗: 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
次要结局
- Participant demographic data(Baseline)
- Concussion history data(Baseline)