Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate at which program was accepted, measured by attendance to assess acceptability of treatment
研究概览
简要总结
The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care (Web-MEUC) among adult patients with a painful non-traumatic upper-extremity condition(s) (PNUC) and commorbid risky substance use.
Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, and other study materials. [2] Assess the feasibility, acceptability, and credibility of Web-TIRELESS and Web-MEUC in preparation for future research.
详细描述
Aim: Conduct a feasibility randomized controlled trial (RCT) (N=50) of Web-TIRELESS versus Minimally Enhanced Usual Care (Web-MEUC)-both of which are web-based-among patients with painful nontraumatic upper extremity conditions and comorbid risky substance use (N=50), to demonstrate the feasibility of recruitment procedures and data collection; and the feasibility, credibility, and acceptability (adherence, retention, fidelity, and satisfaction) of Web-TIRELESS and Web-MEUC. We will use this mixed-methods information to assess the primary outcomes and optimize both programs and study methodology in preparation for research.
Participants are randomized to either Web-TIRELESS or Web-MEUC and given access to the respective program for approximately 5 weeks to review and complete the assigned material. Both groups are given education material to help improve pain and substance use urge coping. There are 3 assessment points consisting of self-report surveys: baseline, post-program, and 6-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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient adults seeking care in the Hand and Arm Center
- •Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
- •Pain score > 4 on the Numerical Rating Scale (NRS)
- •Risky substance use (scores >10 and <27 for alcohol, and >3 and <27 for cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, tobacco products, and e-cigarette on The World Health Organization's - Alcohol, Smoking and Substance Involvement Screening Test [WHO-ASSIST])
- •Owns a smartphone, laptop, or computer with internet access
- •English fluency
- •Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention
排除标准
- •Participation in mind-body or specialized substance abuse treatment in the past 3 months
- •Practice of mindfulness >45 minutes/week in the past 3 months
- •Psychotropic medications (e.g. antidepressants) changed in the past 3 months
- •Serious untreated mental illness (e.g., Schizophrenia)
- •Suicidal ideation with intent or plan
- •Secondary gains that may bias motivation (e.g., pending disability claim),
- •Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))
- •History of surgery for the presented NPUC within the past 6 months OR future plans for surgery.
研究组 & 干预措施
Web-TIRELESS
A 4-session, asynchronous, web-based mind-body pain and substance use management intervention.
干预措施: Web-TIRELESS (Behavioral)
Web-MEUC
Open access to a web-based pamphlet containing brief, educational information and coping techniques.
干预措施: Web-MEUC (Other)
结局指标
主要结局
Rate at which program was accepted, measured by attendance to assess acceptability of treatment
时间窗: Post-Test (5 Weeks)
The proportion of Web-TIRELESS participants who complete \> or = 3 of 4 sessions.
The percent of patients that agree to participate to assess feasibility of recruitment
时间窗: Baseline (0 Weeks)
The percent of eligible patients approached that agree to participate.
Adherence to homework
时间窗: Throughout intervention completion, an average of 1 month
Rate of Web-TIRELESS participant's completion of homework assigned throughout the study.
Adverse Events
时间窗: Throughout intervention completion, an average of 1 month
Any self-reported or observed negative events related to participation.
Rate of participant's completion of self-report measures to assess feasibility of assessments
时间窗: Baseline (0 Weeks), Post-Test (5 Weeks)
Investigators will report number of patients who complete assessments at each time-point.
Credibility and Expectancy Questionnaire (CEQ)
时间窗: Baseline (0 Weeks)
Assesses the degree to which one believes the intervention will effectively manage their condition, substance use, and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.
Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
时间窗: Post-Test (5 Weeks)
Participants' satisfaction with treatment received after completion. The score range is 0-12. Higher scores indicate greater satisfaction.
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
时间窗: Post-Test (5 Weeks)
This measure will assess how well patients like the Wed-based program content and delivery. Total raw scores range from 22 to 110 with higher scores indicating greater satisfaction with the platform.
次要结局
- PROMIS Emotional Distress - Anxiety-Short Form 8a v1.0(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Pain Catastrophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Graded Chronic Pain Scale (GCPS)(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Disabilities of the Arm, Shoulder and Hand (DASH)(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8a v1.0(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Pain Anxiety Symptoms Scale - Short Form (PASS-20)(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Pain Vigilance and Awareness Questionnaire (PVAQ)(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Brief Experiential Avoidance Questionnaire (BEAQ)(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- Current Opioid Misuse Measure (COMM)(Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months))
- The Timeline Follow Back (TLFB)(Throughout intervention completion, an average of 1 month)
- Numerical Rating Scale (NRS)(Eligibility Screening (-1 Weeks))
研究者
Jafar Bakhshaie
Principal Investigator
Massachusetts General Hospital