Clinical trial NCT06366633: Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Nontraumatic Injury
Substance Use
Upper Extremity Problem
Keywords: Upper Extremity Condition
Risky substance Use
Mindfulness
Nontraumatic conditions
Chronic pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-04-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigator aims to conduct an open pilot study (N=12; 10 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.

Detailed description: Aim: Conduct a pilot study (N=12; 10 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.

Eligibility criteria: Inclusion Criteria:

1. Outpatient adults seeking care in the Hand and Arm Center
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:

1. Participation in mind-body or specialized substance abuse treatment in the past 3 months
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

Primary outcomes:
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline (0 Weeks)
measure: Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
timeFrame: Post-Test (4 Weeks)
measure: The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
timeFrame: Post-Test (4 Weeks)
measure: The percent of patients that agree to participate to assess feasibility of recruitment
timeFrame: Baseline (0 Weeks)
measure: Rate at which program was accepted, measured by attendance to assess acceptability of treatment
timeFrame: Post-Test (4 Weeks)
measure: Adherence to homework
timeFrame: Through intervention completion, an average of 1 month
measure: Rate of participant's completion of self-report measures to assess feasibility of assessments
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Adverse Events
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Graded Chronic Pain Scale (GCPS)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Pain Anxiety Symptoms Scale - Short Form (PASS-20)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Pain Vigilance and Awareness Questionnaire (PVAQ)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: Current Opioid Misuse Measure (COMM)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
measure: The Timeline Follow Back (TLFB)
timeFrame: Through intervention completion, an average of 1 month
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jafar Bakhshaie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: