Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Pain
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

Mood and anxiety disorders are 2 to 7 times more prevalent in patients with chronic pain, and comorbid chronic pain and psychiatric conditions results in poorer prognosis.(1) Patients with chronic pain struggle to gain control of their disease and a significant proportion of these patients are on hi...

Mood and anxiety disorders are 2 to 7 times more prevalent in patients with chronic pain, and comorbid chronic pain and psychiatric conditions results in poorer prognosis.(1) Patients with chronic pain struggle to gain control of their disease and a significant proportion of these patients are on high dose opioids (i.e. greater than 90 mg of morphine equivalents/day).(2) Treatment of chronic pain in the context of mental distress/psychological comorbidity and/or opioid use is complex and the investigators have therefore adopted the term 'complex chronic pain' (CCP) to identify the unique needs of these patients. Due to public health measures to control the spread of COVID-19, pain clinics across the country have ceased or severely restricted in-person visits,(3) which significantly impacts care of the 15-19% of Canadians who struggle with chronic pain.(4) Thus, chronic pain patients have lost resources that were their mainstay of stability such as routine physiotherapy and psychotherapy. Moreover, additional stresses related to social isolation, delay of medical procedures that reduce symptoms and improve quality of life, and anxiety regarding possible COVID-19 infection or impact from actual infection on self or loved ones further impact mental health. This is reflected in a recent survey of multidisciplinary Canadian pain clinics where increased pain, stress, and opioid use has been observed as a result of the COVID-19 pandemic.(3) For individuals with CCP who are already vulnerable to declining mental health and/or increased substance misuse/abuse, these compounded stresses in combination with decreased mental health-related resources are especially troubling and possibly deadly. Indeed, in our chronic pain clinics the investigators have observed first-hand an increase in the suffering that these patients are enduring since the start of the COVID-19 pandemic including significant increases in the number of early refills of opioid medications, suicides and requests for medical assistance in dying. There is an urgent need to address the mental health and substance use needs of individuals with CCP who have been negatively impacted by the current COVID-19 pandemic. Transformation in Care Delivery Due To COVID-19 The COVID-19 pandemic has thrust change into the clinical world; telemedicine has become the requisite platform to provide evidence-based solutions addressing the needs of individuals living with chronic pain and struggling with opioid use/misuse during the COVID-19 pandemic.(5,6) Multidisciplinary pain clinics have rapidly adapted and begun to integrate virtual approaches to chronic pain and addiction care across the country;(3,7) however, to our knowledge, none specifically address the unique mental health and substance use needs of individuals with CCP. The investigators have recently undertaken three innovations to increase accessibility, reach, and efficiency of psychological services within our clinics (GoodHope Ehlers Danlos Syndrome [EDS] Program and the Transitional Pain Service [TPS], both at the Toronto General Hospital [TGH]) that can be leveraged and expanded to address the mental health and substance use needs of patients with CCP within and beyond our clinic at this critical time of need. The first is integration of a mobile app-based pain management solution, Manage My Pain (MMP), into patient care through an established partnership with ManagingLife (the creators of MMP).(8,9) MMP is a patient-driven mobile health solution that aids patients in tracking their symptoms, facilitates communication with providers, and also administers and scores self-report measures. The second innovation is adaptation of existing evidence-based programs into virtual formats, delivered through Ontario Telemedicine Network (OTN), for patients with poor mental health and/or at risk of substance abuse. Of particular interest, the imvestigators developed and piloted a brief, CCP-specific acceptance and commitment therapy (ACT) workshop as this modern, evidence-based form of cognitive-behavioral therapy (CBT) is associated with improved pain acceptance and functioning,(10) significant reductions in depression and anxiety (medium effect size),(11) and decreased opioid use.(12) Even when distilled into a one-visit workshop, ACT is effective in reducing distress, improving functioning and health behaviors, and decreasing opioid use in at-risk medical populations.(12) Internet-based delivery of psychological interventions improves mood in patients with chronic pain,(13) and at least one study has found that online ACT improved mood up to 3 months post-intervention in patients with chronic pain.(14) The third innovation is development of a stepped-care approach to psychological service referral which uses a measurement-based approach to increase efficiency and reduce patient care costs.(15,16) Briefly, this approach consists of screening for mental health concerns (Step 0) followed by offering a one-time ACT workshop to patients who report mental health concerns (Step 1) and, finally, referral to more intensive group programming based in Dialectic Behavior Therapy (DBT) for patients with continued need (Step 2). This program is well-positioned to make an immediate and important contribution to mental health care for individuals with chronic pain. However, empirical evaluation of this program is still needed. The investigators propose to undertake a prospective, observational study to evaluate the impact and implementation of the virtually-delivered, stepped care mental health program. Purpose and Objectives The goal this study is to evaluate a newly developed, remote method of identifying individuals with CCP who are at increased risk of poor mental health and/or substance use and provide them with accessible mental health-promoting and substance use-reducing resources during the current COVID pandemic and beyond. Objectives Investigate the impact of a stepped care mental health program on mental health and substance use risk factors for individuals with chronic pain Examine rates of mental health and substance use risk factors in TPS and EDS clinic patient populations. Examine uptake of the stepped care treatment model amongst patients in the TPS and EDS clinics. Research Questions: Can a virtually-delivered stepped care mental health program benefit individuals with complex chronic pain and increased risk for mental health and substance use? What are current rates of mental health and substance use concerns during the COVID-19 pandemic for individuals in the TPS and EDS clinics? Will patients in the TPS and EDS clinics participate in a remote mental health and substance use screening and treatment program? Study Design The investigators propose a prospective, observational study to evaluate the implementation of a remotely-delivered, stepped-care model of psychological treatment. Patients from the GoodHope Ehlers Danlos Syndrome Program and Transitional Pain Service will be invited to complete mental health screening and engage with the self-management application Manage My Pain (Step 0) and, as needed, participate in a one-time Acceptance and Commitment Therapy (Step 1), and a 6-week Dialectic Behavior Therapy Group (Step 2). Patients will be asked to complete self-report measures one-month after participation in each step of the program.

Tracking Information

NCT #
NCT04885192
Collaborators
Not Provided
Investigators
Principal Investigator: Hance Clarke, MD, PhD Toronto General Hospital