Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use

Jafar Bakhshaie

Status: Completed

Conditions: Orthopedic Disorder; Substance Use; Upper Extremity Problem; Nontraumatic Injury

Treatments: Behavioral: Web-TIRELESS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06366633

2024P000713

1K23AT012364-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Web-TIRELESS

Experimental group

Description:

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.

Treatment:

Behavioral: Web-TIRELESS