Feasibility Open Pilot of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Nontraumatic Painful Upper Extremity Conditions and Comorbid Risky Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Adherence to homework
研究概览
简要总结
The investigator aims to conduct an open pilot study (N=6; 5 completers) 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) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and 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 in preparation for a future feasibility RCT.
Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations.
详细描述
Aim: Conduct a pilot study (N=6; 5 completers) of Web-TIRELESS followed by virtual exit interviews with adult patients with painful nontraumatic upper extremity conditions and comorbid risky substance use. The investigators will use this mixed methods information to assess the feasibility, credibility, and acceptability of Web-TIRELESS and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).
The Web-TIRELESS program, adapted from the Toolkit for Optimal Recovery (P# 2020P000095), consists of 4 on-demand video sessions each being approximately 30-45 minutes long. The sessions aim to teach mind-body skills, cognitive-behavioral strategies (e.g., reframing, pain and substance use urge surfing), activity pacing, acceptance and commitment skills, and psychoeducation on the association between substance use and pain. Each session will consist of a combination of short (5-10 min) educational videos, exercises, and guided home practice goal-setting. At the end of each session, each participant will complete an interactive quiz that covers the subject of the session to facilitate deeper understanding and internalization of the session content. The interactive quiz format has been demonstrated to be useful for learning new information, including among orthopedic patients. Between sessions, participants will be encouraged to practice program skills at home. Home practice materials include Web-based audio and video clips (e.g., 5 min mindfulness of pain and substance urge). Outside the on-demand sessions, participants will continue to use the web-based platform to guide and log their home practice.
After completion of the program, participants will attend a one-time 15-30 minute exit interview to share their perceptions of Web-TIRELESS and any recommendations to improve quality. This information will be used to further adapt and optimize Web-TIRELESS prior to future study phases.
Assessments: Participants will complete baseline and post-test assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
研究组 & 干预措施
Web-TIRELESS
An asynchronous web-based mind-body intervention focused on decreasing disability, pain, risky substance use, and related distress in patients with nontraumatic upper-extremity conditions and comorbid risky substance use.
干预措施: Web-TIRELESS (Behavioral)
结局指标
主要结局
Adherence to homework
时间窗: Through intervention completion, an average of 1 month
Rate of participant's completion of homework assigned throughout the study.
Rate of participant's completion of self-report measures to assess feasibility of assessments
时间窗: Baseline (0 Weeks), Post-Test (4 Weeks)
Investigators will report number of patients who complete assessments at each time-point.
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.
Adverse Events
时间窗: Through study completion, an average of 1 month
Any self-reported or observed negative events related to participation
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 (4 Weeks)
Participant's 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 (4 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.
Rate at which program was accepted, measured by attendance to assess acceptability of treatment
时间窗: Post-Test (4 Weeks)
The proportion of participants who complete \> or = 3 of 4 sessions.
次要结局
- Pain Catastrophizing Scale (PCS)(Baseline (0 Weeks), Post-Test (4 Weeks))
- Current Opioid Misuse Measure (COMM)(Baseline (0 Weeks), Post-Test (4 Weeks))
- Brief Experiential Avoidance Questionnaire (BEAQ)(Baseline (0 Weeks), Post-Test (4 Weeks))
- Numerical Rating Scale (NRS)(Baseline (0 Weeks), Post-Test (4 Weeks))
- Disabilities of the Arm, Shoulder and Hand (DASH)(Baseline (0 Weeks), Post-Test (4 Weeks))
- PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0(Baseline (0 Weeks), Post-Test (4 Weeks))
- Pain Anxiety Symptoms Scale - Short Form (PASS-20)(Baseline (0 Weeks), Post-Test (4 Weeks))
- Pain Vigilance and Awareness Questionnaire (PVAQ)(Baseline (0 Weeks), Post-Test (4 Weeks))
- The Timeline Follow Back (TLFB)(Through intervention completion, an average of 1 month)
- Graded Chronic Pain Scale (GCPS)(Baseline (0 Weeks), Post-Test (4 Weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0(Baseline (0 Weeks), Post-Test (4 Weeks))
研究者
Jafar Bakhshaie
Principal Investigator
Massachusetts General Hospital