Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJafar Bakhshaie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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])
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Web-TIRELESS
BehavioralThis 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.
Web-MEUC
Other interventionAn 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Web-TIRELESSExperimental treatment 1 intervention
Group B: Web-MEUCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Credibility and Expectancy Questionnaire (CEQ)
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.
Time frame
Baseline (0 Weeks)2
Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
Participants' satisfaction with treatment received after completion. The score range is 0-12. Higher scores indicate greater satisfaction.
Time frame
Post-Test (5 Weeks)3
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
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.
Time frame
Post-Test (5 Weeks)4
The percent of patients that agree to participate to assess feasibility of recruitment
The percent of eligible patients approached that agree to participate.
Time frame
Baseline (0 Weeks)Secondary outcomes
1
Graded Chronic Pain Scale (GCPS)
Assesses pain severity and pain-related disability. Total scores range from 0 to 10, with higher scores indicating worse pain severity.
Time frame
Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)2
Disabilities of the Arm, Shoulder and Hand (DASH)
A 30-item measure that assesses disability severity. Scores range from 0 to 100 with higher scores indicating greater disability.
Time frame
Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)3
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8a v1.0
An 8-item measure assessing symptoms of depression. Scores range from 8 to 40 with higher scores indicating greater symptom severity
Time frame
Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)4
PROMIS Emotional Distress - Anxiety-Short Form 8a v1.0
An 8-item measure assessing symptoms of anxiety. Scores range from 8 to 40, with higher scores indicating greater symptom severity.
Time frame
Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jafar Bakhshaie
Lead sponsor
Massachusetts General Hospital
Sponsor institution
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov