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ACTIVE NOT RECRUITING
NCT04885192

Implementation and Evaluation of a Stepped-Care Mental Health Treatment Program for Patients With Chronic Pain

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: Implementation and Evaluation of a Virtually-Delivered, Stepped-Care Mental Health Treatment Program for Patients With Chronic Pain During COVID-19

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2021-03-01

Completion Date

2025-12-31

Last Updated

2025-07-08

Healthy Volunteers

No

Conditions

Interventions

OTHER

Stepped-Care Model

Step 0: Screening via Manage My Pain (MMP) App. Patients using MMP will be prompted to complete questionnaires on pain catastrophizing, depressive symptoms, anxiety, suicide risk and opioid risk. Those scoring above clinical risk cut-offs will be referred to Step 1. Step 1: Acceptance and Commitment Therapy (ACT) Workshop. Patients will be offered a virtual ACT workshop focusing on practical coping skills for dealing with pain, emotional dysregulation, and disability, while maximizing functioning and quality of life with chronic pain. Thirty days later, patients will be prompted to complete all questionnaires through MMP again; those who score above clinical risk cut-offs will be referred to Step 2. Step 2: Dialectic Behavior Therapy (DBT) group. A 6-week DBT-based skills group will cover topics such as self-compassion, radical acceptance, distress tolerance, and mindfulness, among others. Thirty days later, patients will be prompted to complete questionnaires through MMP.

Locations (1)

University Health Network- Toronto General Hospital

Toronto, Ontario, Canada