Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use
NCT ID: NCT06366633
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
5 participants
INTERVENTIONAL
2024-10-29
2025-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Web-TIRELESS
This is a self-administered web-based intervention that consists of 4 30-45-minute video sessions 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Web-TIRELESS
This is a self-administered web-based intervention that consists of 4 30-45-minute video sessions 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
3. Pain score \> 4 on the Numerical Rating Scale (NRS)
4. 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 \[WHO-ASSIST\])
5. Owns a smartphone, laptop, or computer with internet access
6. Age ≥18yr
7. English fluency
8. Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention
Exclusion Criteria
2. Practice of mindfulness \>45 minutes/week in the past 3 months
3. Psychotropic medications (e.g. antidepressants) changed in the past 3 months
4. Serious untreated mental illness (e.g., Schizophrenia)
5. Suicidal ideation with intent or plan
6. Pregnancy
7. Secondary gains that may bias motivation (e.g., pending disability claim),
8. Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))
9. History of surgery for the presented NPUC within the past 6 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center for Complementary and Integrative Health (NCCIH)
NIH
Jafar Bakhshaie
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jafar Bakhshaie
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jafar Bakhshaie, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Levey N, Chen N, Ditre J, Sylvia L, Mudgal C, Bhashyam A, Garg R, Ring D, Vranceanu AM, Bakhshaie J. A Web-Based Mind-Body Intervention to Improve Resilience Among Patients With Nontraumatic Painful Upper-Extremity Conditions and Comorbid Risky Substance Use: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2024 Dec 9;13:e64547. doi: 10.2196/64547.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024P000713
Identifier Type: -
Identifier Source: org_study_id