Web-Based Mind-Body Program for Arm Problems and Substance Use Disorders

Recruiting at 1 trial location

Overseen By Nadine Levey, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jafar Bakhshaie

Must not be taking: Psychotropic medications

Disqualifiers: Serious mental illness, Suicidal ideation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your psychotropic medications (like antidepressants) have changed in the past 3 months, you may not be eligible to participate.

What data supports the effectiveness of the treatment Web-TIRELESS for arm problems and substance use disorders?

Research shows that a comprehensive treatment program combining mindfulness and other therapies significantly improved depression, pain, and quality of life in patients with chronic pain and substance use disorders. Additionally, a pilot study found that a mind-body therapy improved self-awareness and was well-received by participants with opioid use disorder, suggesting potential benefits for similar treatments. ^{1 2 3 4 5}

Is the Web-Based Mind-Body Program for Arm Problems and Substance Use Disorders safe for humans?

The available research on similar web-based mind-body programs, like Mindful Awareness in Body-oriented Therapy (MABT), suggests they are generally safe for humans, with high participant satisfaction and no reported safety issues. ^{2 6 7 8 9}

How is the Web-TIRELESS treatment different from other treatments for arm problems and substance use disorders?

Web-TIRELESS is unique because it combines a web-based mind-body approach with cognitive behavioral therapy (CBT) to address both arm problems and substance use disorders. This online format allows for flexible, on-demand access, which can be more convenient and accessible than traditional in-person therapy sessions. ^{2 9 10 11 12}

Research Team

Jafar Bakhshaie, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with non-traumatic painful conditions in the upper extremities (like arm issues or sprains) who also have risky substance use habits. Details on specific inclusion and exclusion criteria are not provided, but typically these would outline the specifics of what constitutes 'risky' substance use and any other health considerations.

Inclusion Criteria

Owns a smartphone, laptop, or computer with internet access

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])

I have a painful arm condition not caused by injury.

Exclusion Criteria

Pregnancy

Serious untreated mental illness (e.g., Schizophrenia)

Secondary gains that may bias motivation (e.g., pending disability claim)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 4 on-demand video sessions at their own pace, approximately 1 session per week, focusing on mind-body skills and cognitive-behavioral strategies.

4 weeks

On-demand sessions

Follow-up

Participants complete post-test assessments and attend a one-time exit interview to provide feedback on the program.

1 week

1 virtual visit (exit interview)

Treatment Details

Interventions

• Web-TIRELESS

Trial Overview The study is testing Web-TIRELESS, a web-based mind-body program designed to help people manage pain in their arms without relying too much on substances. Participants will go through 4 video sessions at their own pace, usually one per week, and provide feedback after completion.

Participant Groups

Group I: Web-TIRELESS Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Jafar Bakhshaie

Lead Sponsor

Trials

1

Recruited

10+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

A cohort of patients with chronic pain and substance use disorder showed significant improvements in depression, pain, and quality of life after participating in a comprehensive inpatient treatment program that included detoxification, qigong, and 12-step recovery support.

The most notable improvements were observed between the initial assessment and the second assessment at 30 days, indicating that this integrated approach may effectively address both chronic pain and substance use issues in patients who have not responded to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive treatment for patients with chronic pain in a 12-step based substance use disorder program. Przekop, P., Przekop, A., Haviland, MG., et al.[2019]

The pilot study successfully recruited and retained 10 participants within two weeks, demonstrating the feasibility of implementing the Mindful Awareness in Body-oriented Therapy (MABT) alongside buprenorphine treatment for opioid use disorder.

Participants in the MABT group showed significant improvements in interoceptive awareness skills compared to the control group, and feedback indicated high satisfaction with the intervention, suggesting it could be a beneficial adjunct therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder. Price, CJ., Merrill, JO., McCarty, RL., et al.[2021]

In a study of 120 patients with chronic non-cancer pain and therapeutic opioid addiction, only 22.5% resumed opioid use after 12 months, indicating effective management within a chronic pain rehabilitation program.

The likelihood of resuming opioid use was not influenced by addiction status, but increased post-treatment depression was a significant predictor, suggesting that addressing mental health is crucial for maintaining abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid use 12 months following interdisciplinary pain rehabilitation with weaning. Huffman, KL., Sweis, GW., Gase, A., et al.[2013]

In a study of 127 patients with on-the-job injuries undergoing a multidisciplinary rehabilitation program, both opioid users and nonusers showed significant improvements in psychological and physical functioning after treatment.

There were no significant differences in treatment outcomes between opioid users and nonusers, suggesting that opioid use does not hinder the success of rehabilitation for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of opioid use on outcomes of functional restoration. Maclaren, JE., Gross, RT., Sperry, JA., et al.[2006]

A multisite randomized controlled trial involving 160 veterans with chronic pain and opioid use disorder will evaluate the efficacy of an integrated treatment combining Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, focusing on pain interference and hazardous opioid use.

The study aims to address a significant gap in treatment options by assessing outcomes over 12 months, including pain interference and opioid misuse, which could lead to improved care for veterans on buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. Vowles, KE., Witkiewitz, K., Clarke, E., et al.[2023]

In a randomized controlled trial with 63 opioid-treated chronic pain patients, the combination of Mindfulness-Oriented Recovery Enhancement (MORE) and Just-in-Time Adaptive Intervention (JITAI) significantly reduced cravings, pain, and stress while increasing positive affect compared to a supportive group therapy control.

The JITAI prompts, triggered by wearable sensors detecting physiological stress, were effective in encouraging mindfulness practice, leading to improvements in heart rate variability (HRV) and overall well-being, suggesting that this intervention could be a valuable tool in addressing opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoom-Based Mindfulness-Oriented Recovery Enhancement Plus Just-in-Time Mindfulness Practice Triggered by Wearable Sensors for Opioid Craving and Chronic Pain. Garland, EL., Gullapalli, BT., Prince, KC., et al.[2023]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The Mindful Recovery OUD Care Continuum (M-ROCC) program, a 24-week mindfulness-based intervention, significantly reduced comorbid pain and anxiety in patients undergoing buprenorphine treatment, as evidenced by improved scores on various psychological scales and decreased substance use.

Participants showed a notable decrease in positive urine toxicology results for cocaine and benzodiazepines, indicating that M-ROCC may help enhance retention in treatment and prevent substance misuse during opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Schuman-Olivier, Z., Fatkin, T., Creedon, TB., et al.[2023]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

Web-based interventions for substance use disorders are currently under-researched, with no large randomized controlled trials available, indicating a significant gap in the evidence base for their effectiveness.

Despite the limited and flawed literature, there is a strong demand for internet-based interventions, suggesting they could be as effective as traditional therapy for less severe cases of substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based interventions for substance use disorders: a qualitative review. Copeland, J., Martin, G.[2006]

A web-based cognitive behavioral therapy (CBT) intervention significantly reduced pain catastrophizing in chronic pain patients, which led to decreased pain interference and severity, demonstrating its efficacy in managing chronic pain.

The intervention was particularly effective for younger patients (≤ 50 years) and those with a history of substance use disorder, indicating that web-CBT may be especially beneficial for these groups in reducing both pain and aberrant drug-related behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based cognitive behavior therapy for chronic pain patients with aberrant drug-related behavior: How did it work and for whom? Xie, H., Guarino, H., Moore, SK., et al.[2021]

Computer-based interventions for drug use disorders have shown high acceptability and can lead to reduced substance use, increased motivation to change, and better retention compared to traditional treatment methods, based on a review of 12 studies.

These interventions offer a promising alternative due to their lower cost and greater accessibility, suggesting they could significantly transform treatment approaches for drug use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. Moore, BA., Fazzino, T., Garnet, B., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comprehensive treatment for patients with chronic pain in a 12-step based substance use disorder program. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Opioid use 12 months following interdisciplinary pain rehabilitation with weaning. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of opioid use on outcomes of functional restoration. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Rationale and design of a multisite randomized clinical trial examining an integrated behavioral treatment for veterans with co-occurring chronic pain and opioid use disorder: The pain and opioids integrated treatment in veterans (POSITIVE) trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Zoom-Based Mindfulness-Oriented Recovery Enhancement Plus Just-in-Time Mindfulness Practice Triggered by Wearable Sensors for Opioid Craving and Chronic Pain. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Web-based interventions for substance use disorders: a qualitative review. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Web-based cognitive behavior therapy for chronic pain patients with aberrant drug-related behavior: How did it work and for whom? [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. [2022]