Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
研究概览
简要总结
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).
详细描述
The investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, TOR-C 1 and TOR-C 2. The investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Both programs will be delivered virtually (Zoom).
Each program will consist of four 45-minute sessions over the secure Zoom platform. Participants will receive a treatment manual. There are 3 assessment points consisting of self-report surveys: baseline, post program, and 3-month follow-up.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female outpatients, ages 18-35
- •English fluency and literacy
- •Diagnosed with a concussion in the past 10 weeks
- •Owns a smartphone or computer with Internet access
- •Willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program
- •Free of concurrent psychotropic or have been on stable dosage for at least 6 weeks
- •Clinically significant anxiety symptoms (score ≥ 5 on GAD-7 anxiety scale)
排除标准
- •Previous history of moderate or severe TBI OR concussion in the past 2 years that resulted in symptoms lasting 3 months or more
- •Diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy)
- •Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
- •Current substance abuse or dependence and current substance use disorder
- •Current active self-reported suicidal ideation
- •Practice of mindfulness techniques for greater than 45 minutes per week within the last 3 months
- •Participation in a mind-body or CBT treatment in the past 3 months
- •Currently pregnant
研究组 & 干预措施
TOR-C 1
TOR-C 1 is an active intervention adapted from the original Toolkit for Optimal Recovery program, adjusted for patients with mTBI and anxiety. The TOR-C 1 sessions address mind-body skills, including eliciting the relaxation response (eg, body scan, deep breathing, mindfulness), cognitive-behavioral strategies (eg, reframing), acceptance and commitment skills (eg, acceptance), and skills for returning to activity (eg, goal setting, activity pacing). The format is a 4-week program delivered over live video with weekly sessions and home practice.
干预措施: TOR-C 1 (Behavioral)
TOR-C 2
TOR-C 2 is an active intervention teaching educational information on key modifiable factors relating to recovery after concussion, such as return to activity, the role of nutrition and sleep, and the relationship between concussion and anxiety. The format is a 4-week program delivered over live video with weekly sessions.
干预措施: TOR-C 2 (Behavioral)
结局指标
主要结局
Number of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire (CEQ)
时间窗: Baseline (0 Weeks)
Assessed using the Credibility and Expectancy Questionnaire (CEQ) which asks the participant indicate how much they believe, right now, that the intervention they will receive will help manage their concussion and related worry. Possible scores on both the credibility and expectancy subscales range from 3 to 27 and have a midpoint score of 14. The number of participants that scored at or above 14 on the credibility and/or expectancy subscales are reported below.
Number of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
时间窗: Post-Test (4 Weeks)
Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Feasibility of Recruitment
时间窗: Baseline (0 Weeks)
Rate at which recruitment was possible
Acceptability of Treatment
时间窗: Post-Test (4 Weeks)
Rate at which program was accepted, measured by attendance.
Adherence to Homework
时间窗: Collected during intervention, an average of 4 weeks
Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study.
Therapist Adherence
时间窗: Collected during intervention, an average of 4 weeks
Rate of interventionist's delivering the programs by following the established session topics and practices
Feasibility of Assessments at Baseline
时间窗: Baseline (0 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
Feasibility of Assessments at Post-Test
时间窗: Post-Test (4 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
Feasibility of Assessments at Follow-up
时间窗: Follow-up (12 Weeks)
Rate of participant's completion of self-report measures, with no measures missing
Adverse Events
时间窗: Collected during intervention, an average of 4 weeks
Any self reported or observed negative events related to participation
次要结局
- Numerical Rating Scale(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Post-Concussion Symptom Scale (PCSS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Generalized Anxiety Disorder Scale (GAD-7)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Hospital Anxiety And Depression Scale (HADS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- World Health Organization - Disability Assessment Schedule 2.0 (WHODAS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Fear Avoidance Behavior After Traumatic Brain Injury (FAB-TBI)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Pain Catastophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Behavioral Response To Illness (BRIQ) - Limiting Behaviors Subscale(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
- Behavioral Response To Illness (BRIQ) - All-or-Nothing Subscale(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-Up (12 Weeks))
研究者
Jonathan Greenberg
Principal Investigator
Massachusetts General Hospital