Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain

Официальное название

Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Web-TIRELESS
  This is a self-administered web-based intervention that consists of 4 on-demand sessions, each \~30 minutes long, that 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. The program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive substance use behaviors.
• Другое Web-MEUC
  An educational information web-based pamphlet, containing brief, summarized information tailored for the respective patient population that follows topics including the trajectory of pain and adaptation after non-traumatic painful upper extremity conditions, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living.

Первичные конечные точки

• Credibility and Expectancy Questionnaire (CEQ) [Срок оценки: Baseline (0 Weeks)]
• Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment [Срок оценки: Post-Test (5 Weeks)]
• The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery [Срок оценки: Post-Test (5 Weeks)]
• The percent of patients that agree to participate to assess feasibility of recruitment [Срок оценки: Baseline (0 Weeks)]
• Rate at which program was accepted, measured by attendance to assess acceptability of treatment [Срок оценки: Post-Test (5 Weeks)]
• Adherence to homework [Срок оценки: Throughout intervention completion, an average of 1 month]
• Rate of participant's completion of self-report measures to assess feasibility of assessments [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks)]
• Adverse Events [Срок оценки: Throughout intervention completion, an average of 1 month]

Вторичные конечные точки (11)

• Graded Chronic Pain Scale (GCPS) [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• Disabilities of the Arm, Shoulder and Hand (DASH) [Срок оценки: 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 [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• PROMIS Emotional Distress - Anxiety-Short Form 8a v1.0 [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• Pain Anxiety Symptoms Scale - Short Form (PASS-20) [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• Pain Vigilance and Awareness Questionnaire (PVAQ) [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• Brief Experiential Avoidance Questionnaire (BEAQ) [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• Current Opioid Misuse Measure (COMM) [Срок оценки: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)]
• The Timeline Follow Back (TLFB) [Срок оценки: Throughout intervention completion, an average of 1 month]
• Numerical Rating Scale (NRS) [Срок оценки: Eligibility Screening (-1 Weeks)]

Критерии участия

Критерии включения

• 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
• Age ≥18yr
• English fluency
• Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention

Критерии исключения

• 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
• Pregnancy
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06991205 · 2025P001335 · 5K23AT012364-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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