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

April 18, 2024 updated by: Jafar Bakhshaie

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Credibility and Expectancy Questionnaire (CEQ)
Time Frame: Baseline (0 Weeks)
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.
Baseline (0 Weeks)
Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
Time Frame: Post-Test (4 Weeks)
Participant's satisfaction with treatment received after completion . The score range is 0-12. Higher scores indicate greater satisfaction.
Post-Test (4 Weeks)
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
Time Frame: Post-Test (4 Weeks)
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.
Post-Test (4 Weeks)
The percent of patients that agree to participate to assess feasibility of recruitment
Time Frame: Baseline (0 Weeks)
The percent of eligible patients approached that agree to participate.
Baseline (0 Weeks)
Rate at which program was accepted, measured by attendance to assess acceptability of treatment
Time Frame: Post-Test (4 Weeks)
The proportion of participants who complete > or = 3 of 4 sessions.
Post-Test (4 Weeks)
Adherence to homework
Time Frame: Through intervention completion, an average of 1 month
Rate of participant's completion of homework assigned throughout the study.
Through intervention completion, an average of 1 month
Adverse Events
Time Frame: Through study completion, an average of 1 month
Any self-reported or observed negative events related to participation
Through study completion, an average of 1 month
Rate of participant's completion of self-report measures to assess feasibility of assessments
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
Investigators will report number of patients who complete assessments at each time-point.
Baseline (0 Weeks), Post-Test (4 Weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graded Chronic Pain Scale (GCPS)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
Assesses pain severity and pain related disability. Total scores range from 0 to 10 with high scores indicating worse pain severity.
Baseline (0 Weeks), Post-Test (4 Weeks)
Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
A 30-item measure that assesses disability severity. Scores range from 0 to 100 with higher scores indicating greater disability.
Baseline (0 Weeks), Post-Test (4 Weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
An 8-item measure assessing symptoms of depression. Scores range from 8 to 40 with higher scores indicating greater symptom severity
Baseline (0 Weeks), Post-Test (4 Weeks)
PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
An 8-item measure assessing symptoms of anxiety. Scores range from 8 to 40 with higher scores indicating greater symptom severity
Baseline (0 Weeks), Post-Test (4 Weeks)
Pain Catastrophizing Scale (PCS)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
Assesses magnification, helplessness, and rumination about pain. Scores range from 0 to 52. Higher scores indicate greater pain catastrophizing.
Baseline (0 Weeks), Post-Test (4 Weeks)
Pain Anxiety Symptoms Scale - Short Form (PASS-20)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
Assesses fear and anxiety related to pain. Scores range from 0 to 100. Higher scores indicate greater pain-related fear and anxiety.
Baseline (0 Weeks), Post-Test (4 Weeks)
Pain Vigilance and Awareness Questionnaire (PVAQ)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
Assesses preoccupation with or attention to pain. Scores range from 16 to 96. Higher scores indicate greater pain vigilance.
Baseline (0 Weeks), Post-Test (4 Weeks)
Brief Experiential Avoidance Questionnaire (BEAQ)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
This measure assesses tendencies to avoid unpleasant internal experiences. Scores range from 15 to 90. Higher scores suggest greater avoidance behaviors.
Baseline (0 Weeks), Post-Test (4 Weeks)
Current Opioid Misuse Measure (COMM)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
Assesses risk for aberrant medication-related behavior in persons with chronic pain. Scores range from 0 to 68. Higher scores indicate greater risk for opioid misuse.
Baseline (0 Weeks), Post-Test (4 Weeks)
The Timeline Follow Back (TLFB)
Time Frame: Through intervention completion, an average of 1 month
Assesses daily estimates of alcohol, cannabis, cigarette, and other drug use during the past week. The range is 0 to 7 days, with higher scores indicating more severe use.
Through intervention completion, an average of 1 month
Numerical Rating Scale (NRS)
Time Frame: Baseline (0 Weeks), Post-Test (4 Weeks)
Severity of participant's pain at rest and with activity using a Likert scale with 0 being no pain and 10 being worst possible pain.
Baseline (0 Weeks), Post-Test (4 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jafar Bakhshaie

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jafar Bakhshaie, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 14, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000713
  • 1K23AT012364-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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