Clinical trial NCT04885192: Implementation and Evaluation of a Stepped-Care Mental Health Treatment Program for Patients With Chronic Pain
Official title: Implementation and Evaluation of a Virtually-Delivered, Stepped-Care Mental Health Treatment Program for Patients With Chronic Pain During COVID-19
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pain
Keywords: Psychological Treatment
Stepped-Care
Virtual Care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients currently being followed by the GoodHope Ehlers Danlos Syndrome Program or the Transitional Pain Service at Toronto General Hospital.

Brief summary: Chronic pain affects nearly 20% of Canadians, and sixty percent or more of individuals with chronic pain are also struggling with mental health or substance use disorders (referred to as complex chronic pain, or CCP, patients). This is a major concern in the best of times and has become an emergency during the COVID-19 pandemic. Now individuals suffering from chronic pain are faced with the additional challenges of quarantine, including the stress of isolation, delays in much needed medical care, and anxiety of possible infection to self or loved ones. Prior to COVID-19, psychologists at The Transitional Pain Service and the GoodHope Ehlers-Danlos Syndrome Clinic at Toronto General Hospital have adapted gold standard treatments for mental health and substance use for the unique needs of individuals with CCP. The investigators propose to develop these treatments into a virtual intervention that will meet the needs of patients during and after the COVID-19 pandemic. The investigators will use a mobile health application (called Manage My Pain or MMP) already in use by our patients to identify patients with CCP currently struggling with mental health issues or at risk of opioid misuse. Patients identified at risk will be offered a single-session Acceptance and Commitment Therapy workshop and then reassessed one month after the workshop. Patients still reporting high levels of emotional distress or substance use risk at that time will be offered a six-week Dialectic Behavior Therapy-informed group and will be reassessed one month after conclusion of the group. The investigators propose to conduct prospective data collection during the implementation of this program to facilitate 1) evaluation of the impact of stepped-care program components on mental health and substance use concerns, 2) examination of current rates mental health and substance use concerns in patients, and 3) examination of uptake for virtual mental health care amongst patients with chronic pain.

Detailed 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 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

1. Investigate the impact of a stepped care mental health program on mental health and substance use risk factors for individuals with chronic pain
2. Examine rates of mental health and substance use risk factors in TPS and EDS clinic patient populations.
3. 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.

Eligibility criteria: Inclusion Criteria:

* Age: 18-80

Exclusion Criteria:

* Limited comprehension of English
* Known history of serious mental illness (e.g., schizophrenia, dissociative identity disorder)
* Cognitive deficits due to dementia that may affect comprehension (and thereby may limit benefit of the intervention)

Primary outcomes:
measure: Change in Pain Medication Misuse
timeFrame: Baseline to post-intervention (3.5 months)
measure: Change in Pain Catastrophizing
timeFrame: Baseline to post-intervention (3.5 months)
measure: Change in Depression
timeFrame: Baseline to post-intervention (3.5 months)
measure: Change in Anxiety
timeFrame: Baseline to post-intervention (3.5 months)
measure: Change in Suicidal Behaviour
timeFrame: Baseline to post-intervention (3.5 months)
Secondary outcomes:
measure: Change in Pain Intensity
timeFrame: Baseline to post-intervention (3.5 months)
measure: Uptake of the Stepped Care Mental Health Treatment Program
timeFrame: March 2021 to August 2021
measure: Change in Pain Interference
timeFrame: Baseline to post-intervention (3.5 months)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network- Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: Hance Clarke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: