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

NCT04885192 | Active Not Recruiting

• 1 other identifier: 20-6290
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Psychological Treatment; Stepped-Care; Virtual Care

Outcome Measures

Primary Outcomes (5)

• Change in Pain Medication Misuse

  Measured using the Opioid Risk Tool (ORT). The ORT is a brief self-report tool for assessing risk for opioid misuse/abuse. Patients are asked to acknowledge (yes/no) the presence of Opioid Use risk factors, including family history of substance use, personal history of substance use, age between 16-45, history of preadolescent sexual abuse, and current psychological disorder. Each item is assigned a point value, which differs by respondent gender, and the points for each affirmative response are summed to create a total score. A score of 9 or above has been validated as a marker for increased risk for opioid use disorder for individuals with chronic pain on opioid therapy

  Baseline to post-intervention (3.5 months)

• Change in Pain Catastrophizing

  Measured using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report scale that measures a negative cognitive orientation toward pain, featuring helplessness, magnification, and rumination. Patients are asked to rate the degree to which each statement applies to them on a scale from 0, never, to 4, all the time. A total score of 24 or above has been validated as clinical cut off indicating increased risk of negative pain-related outcomes, mental health issues, and opioid misuse/abuse for individuals with chronic pain.

  Baseline to post-intervention (3.5 months)

• Change in Depression

  Measured using the Patient Health Questionnaire - 9 (PHQ-9). The PHQ-9 is a 9-item scale designed to capture symptoms of major depressive disorder. Respondents are asked to rate the frequency at which they experience 9 symptoms of depression (e.g. "little interest or pleasure in doing things", "feeling down, depressed, or hopeless") over the past two weeks on a scale from 0, not at all, to 3, nearly every day. Items are summed to create a total score. Clinical cut offs of 5 (mild depression), 10 (moderate depression), and 15 (severe depression) have been determined and validated. The PHQ-9 has been extensively validated for use with chronic pain patients and has also been identified as a risk factor for opioid misuse in this population.

  Baseline to post-intervention (3.5 months)

• Change in Anxiety

  Measured using the Generalized Anxiety Disorder - 7 (GAD-7). The GAD-7 is a 7-item self-report measure of generalized anxiety. Patients are asked to rate the frequency at which they experience 7 symptoms of generalized anxiety (e.g. "feeling nervous, anxious, or on edge", "not being able to stop or control worrying") over the past two weeks on a scale from 0, not at all, to 3, nearly every day. Clinical cut offs of 5 (mild anxiety), 10 (moderate anxiety), and 15 (severe anxiety) have been determined and validated. This scale has previously been validated as a measure of anxiety symptoms for individuals with chronic pain.

  Baseline to post-intervention (3.5 months)

• Change in Suicidal Behaviour

  Measured using the Suicide Behaviour Questionnaire - Revised (SBQ-R). The SBQ-R is a 4-item self-report measure of suicide risk. Patients are asked about past suicidal behaviour, current suicidal ideation, communication of suicidal ideation, and perceived likelihood of a future suicide attempt. Responses are summed to create a total score ranging from 3-18. A clinical cut-off of 11 has been recommended as a marker of increased suicide risk.

  Baseline to post-intervention (3.5 months)

Secondary Outcomes (3)

• Change in Pain Intensity

  Baseline to post-intervention (3.5 months)

• Uptake of the Stepped Care Mental Health Treatment Program

  March 2021 to August 2021

• Change in Pain Interference

  Baseline to post-intervention (3.5 months)

Interventions

Stepped-Care Model OTHER

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.

Also known as: Psychological screening, Acceptance and Commitment Therapy, Dialectic Behavior Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age: 18-80

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network- Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hance Clarke, MD, PhD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: March 1, 2021
• Primary Completion: February 8, 2022
• Study Completion: December 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

CA (1)