Online Psychology Program for Post-Surgical Pain

(ADOPT-TPS Trial)

Recruiting at 1 trial location

Overseen By Hance Director of Pain Services, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Serious mental illness, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online program designed to manage post-surgery pain using Acceptance and Commitment Therapy (ACT). The program teaches mindfulness skills and offers information on coping with pain. Participants will either use a self-guided version, the Self-Guided Online ACT Program, or attend a psychologist-led workshop. The trial seeks individuals referred for post-surgery pain management who can access the internet. As an unphased trial, it provides a unique opportunity to explore innovative pain management techniques and contribute to advancing care for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this online psychology program is safe for post-surgical pain management?

Research has shown that online pain management programs can help people reduce opioid use and manage pain effectively. One online program enabled participants to lower their daily opioid use while still managing their pain. This suggests that online tools, like the self-guided ACT program under study, might be safe and useful for managing pain after surgery.

No major negative effects have been reported with these types of online programs. As a self-guided, non-drug treatment, it generally poses a low risk for users. However, participants should inform the trial team about any concerns.

Since this trial involves an online therapy program and not a new drug, it is expected to be safe. Participants should feel comfortable asking questions and sharing any concerns during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Online Psychology Program for Post-Surgical Pain because it offers a fresh approach to managing pain using Acceptance and Commitment Therapy (ACT). Unlike traditional pain management options that often focus on medication, this program provides a self-guided, online platform for patients to manage their pain after surgery. This means individuals can access therapy at their own pace and convenience, potentially reducing reliance on opioids. Additionally, the program's flexibility and accessibility may make it easier for more patients to benefit from effective psychological interventions, which are typically available only through in-person sessions with a psychologist.

What evidence suggests that this self-guided online ACT program is effective for post-surgical pain?

Research has shown that Acceptance and Commitment Therapy (ACT) can help manage long-term pain after surgery. Studies have found that online ACT lowers pain levels, reduces the impact of pain on daily life, and improves mental health issues like depression and anxiety. It also enhances mindfulness and emotional management. In this trial, participants will either join a self-guided online ACT program or a psychologist-guided online ACT workshop. Patients using online ACT have reported good results in managing chronic pain. This suggests that the self-guided online ACT program could be a promising option for managing pain after surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Maxwell Slepian, PhD, C Psych

Principal Investigator

Toronto General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic pain after surgery. Participants should be interested in trying an online program to manage their pain, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Patients who have access to a device that can connect to the Internet

I was referred to the TPS after surgery.

Exclusion Criteria

I have undergone TPS psychology therapy.

Patients with a known history of serious mental illness (e.g., psychosis and/or active mania)

Patients who have limited comprehension of English or comprehension deficits due to dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a self-guided or psychologist-guided online ACT program for post-surgical pain and opioid use

4-6 weeks

Follow-up

Participants are monitored for feasibility, acceptability, and treatment adherence after completing the program

4 weeks

Online surveys and interviews

What Are the Treatments Tested in This Trial?

Interventions

• Self-Guided Online ACT Program

Trial Overview

The study tests a self-guided online Acceptance and Commitment Therapy (ACT) program called ADOPT-TPS, which aims to teach mindfulness and educate about post-surgical pain, against the usual psychologist-guided workshops.

How Is the Trial Designed?

Group I: Self-guided Online ACT Experimental Treatment 1 Intervention

The intervention is a self-guided ACT program delivered on an online platform. The program is developed based on the psychologist-guided ACT group intervention for chronic pain and opioid use after surgery.

Group II: Psychologist-guided Online ACT Active Control 1 Intervention

The psychologist-guided ACT group workshop is an evidence-based psychology intervention for chronic pain and opioid use after surgery.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials

17

Recruited

1,600+

York University

Collaborator

Trials

64

Recruited

521,000+

Toronto General Hospital

Collaborator

Trials

27

Recruited

15,500+

Published Research Related to This Trial

A systematic review of five trials involving various surgical procedures found that cognitive behavioral therapy (CBT) significantly reduces pain intensity and disability in patients experiencing postsurgical pain.

The review highlights the need for further research to optimize the delivery and efficacy of CBT and explore newer psychological approaches for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. Nicholls, JL., Azam, MA., Burns, LC., et al.[2022]

Psychoeducation before spinal surgery significantly reduces the consumption of postoperative analgesics, indicating that informed patients may experience less pain after surgery.

Involving a psychologist in surgical care not only enhances patients' physical and mental recovery but also lowers rehabilitation costs, highlighting the importance of addressing patients' fears and anxieties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of surgical psychoeducation on the outcome of spinal surgery]. Sütő, J., Klekner, Á., Nagy, J., et al.[2023]

Chronic postsurgical pain (CPSP) is influenced by psychological factors, with negative emotions like anxiety and depression identified as significant risk factors, while protective factors are less studied.

The Acceptance and Commitment Therapy (ACT) approach used in the Transitional Pain Service at Toronto General Hospital shows promise in reducing pain and opioid use, with patients receiving this intervention reporting greater improvements in pain management and lower depression scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychology of chronic post-surgical pain: new frontiers in risk factor identification, prevention and management. Weinrib, AZ., Azam, MA., Birnie, KA., et al.[2020]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06455345

Online Psychology Program for Chronic Pain After Surgery

Acceptance and Commitment Therapy (ACT) is an evidence-based psychology intervention that is effective in reducing patients' risk of CPSP and opioid use.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1526590021002078

Review Articles Efficacy of Online-Based Acceptance and ...

Online ACT was more efficacious than controls regarding pain interference, pain intensity, depression, anxiety, mindfulness, and psychological flexibility.

3.

pmc.ncbi.nlm.nih.gov

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Acceptance and commitment therapy for patients with chronic ...

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tandfonline.com

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Online Acceptance and Commitment Therapy for Chronic ...

This case study evaluates the effectiveness of online Acceptance and Commitment Therapy (ACT) for chronic pain management in an older adult.

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Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: A randomized controlled trial.

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Opioid Stewardship - Making Healthcare Safer IV - NCBI - NIH

Opioid stewardship interventions promote the appropriate use of prescribed and ordered opioids to reduce the risk of opioid adverse events.

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cdc.gov

cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ...

This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.

8.

journals.lww.com

journals.lww.com/pain/fulltext/2023/04000/opioid_dose_and_pain_effects_of_an_online_pain.24.aspx

Opioid dose and pain effects of an online pain self ...

This low-burden online intervention could assist adults on LOT in reducing daily opioid use while self-managing pain symptom burdens.

9.

va.gov

va.gov/painmanagement/opioid_safety_initiative_osi.asp

Pain Management, Opioid Safety, and PDMP (PMOP)

Data presented includes key variables that influence patient risk, such as PTSD, Substance Use Disorder (SUD) and Obstructive Sleep Apnea (OSA) as well as the ...

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mdpi.com

mdpi.com/2227-9032/9/3/333

Perioperative Pain Management and Opioid Stewardship

Suboptimal postoperative pain management is associated with worsened humanistic and economic outcomes, including the development of chronic pain and opioid ...