Online Psychology Program for Chronic Pain After Surgery

Not Applicable

Not yet recruiting

• Conditions: Pain, Acute; Pain, Chronic; Post-Surgical Pain, Chronic; Post-surgical Pain
• Interventions: Other: Treatment As Usual; Device: Self-Guided Online ACT Program

• Registration Number: NCT06455345
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This project will evaluate the feasibility of a new fully self-guided online Acceptance and Commitment Therapy (ACT) program entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on an online health application platform called Manage My Pain (MMP). The ACT program is designed to teach mindfulness skills and provide psychoeducation about post-surgical pain. The feasibility of the self-guided online program will be compared to a pre-existing psychologist-guided workshop that delivers the same program. It is anticipated that the self-guided online ACT program will be deemed feasible by participants.

Detailed Description

The Transitional Pain Service (TPS) at Toronto General Hospital is a multidisciplinary treatment program that aims to prevent chronic post-surgical pain (CPSP) and persistent opioid use after surgery. CPSP is a major public health concern impacting from 10% up to 70% of patients, depending on the type of surgery. Those experiencing CPSP are at higher risk for prolonged opioid use, which introduces challenges like addiction, misuse, and overdose. Acceptance and Commitment Therapy (ACT) is an evidence-based psychology intervention that is effective in reducing patients' risk of CPSP and opioid use. However, access to this intervention is currently limited to predominantly in-person, specialized hospital-based clinic settings like the TPS, which prioritize patients at highest risk for CPSP and often require physician referrals for quick access. There is a need for such treatment approaches to spread to other institutions and to be available for lower-risk post-surgery patients, yet the shortage of specialized pain psychologists creates a barrier to widespread dissemination. The current project will evaluate the feasibility of a novel fully self-guided online ACT intervention entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on a mobile health application platform called Manage My Pain (MMP). A randomized, controlled pilot feasibility trial will evaluate the efficacy of ADOPT-TPS by comparing it to a pre-existing psychologist-guided workshop. Once tested, this scalable, evidence-based online intervention can be easily implemented at institutions across Canada and beyond to address CPSP and opioid use without the need for specialized pain psychologists on staff.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-12-27
• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who received a post-surgical referral to the TPS
• Patients who have access to a device that can connect to the Internet

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Exclusion Criteria

• Patients who have received TPS psychology treatment
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychologist-guided Online ACT	Treatment As Usual	The psychologist-guided ACT group workshop is an evidence-based psychology intervention for chronic pain and opioid use after surgery.
Self-guided Online ACT	Self-Guided Online ACT Program	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the online ACT program as assessed by the Feasibility Survey	Participants will be sent a link to fill out the measure within 1 week of completing their respective program.	A 10-item Likert scale (min possible score = 10, max possible score = 70). Higher scores indicate greater feasibility.
Acceptability of the online ACT program as assessed by the Treatment Evaluation Inventory - Short Form	Participants will be sent a link to fill out the measure within 1 week of completing their respective program.	A 9-item Likert scale (min possible score = 9, max possible score = 45). Higher scores indicate greater acceptability.
Retrospective Semi-structured Interview	Participants will be sent an invitation for an interview within 1 month after completing their respective program	A brief interview with a randomized subset of participants
Treatment Adherence as assessed by the Integration of ACT Skills Survey	Participants will be sent a link to complete the measure within 1 month after completing their respective program.	A 5-item Likert scale (min possible score = 5, max possible score = 35). Higher scores indicate greater treatment adherence

Secondary Outcome Measures

Name	Time	Method
Anxiety symptoms as assessed by the PROMIS Emotional Distress - Anxiety - Short Form 8A	Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.	A 8-item Likert scale (min possible score = 8, max possible score = 40). Higher scores indicate greater anxiety symptoms.
Pain Medication Misuse as assessed by the PROMIS Prescription Pain Medication Misuse Scale - Short Form 7a	Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.	A 7-item Likert scale (min possible score = 7, max possible score = 5). Higher scores indicate greater pain medication misuse.
Depressive symptoms as assessed by PROMIS Emotional Distress - Depression - Short Form 8b	Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.	A 8-item Likert scale (min possible score = 8, max possible score = 40). Higher scores indicate greater depressive symptoms.
Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale	Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.	A 16-item Likert scale (min possible score = 16, max possible score = 112). Higher scores indicate greater psychological inflexibility in pain.
Use of Study Platform as assessed by the Use of Manage My Pain Platform Survey	Participants will be sent a link to fill out the measure within 1 week of completing the respective program, and 1 month after completing their respective program.	A 5-item Likert scale (min possible score = 4, max possible score = 20). Higher scores indicate more frequent use of the platform.
Pain Intensity as assessed by the Pain Numerical Rating Scale	Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.	A 4-item Likert scale (min possible score = 0, max possible score = 40). Higher scores indicate greater pain intensity.
Pain Interference as assessed by the PROMIS Pain Interference Scale - Short Form 8a	Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.	A 8-item Likert scale (min possible score = 8, max possible score = 40). Higher scores indicate greater pain interference.
Pain Catastrophizing as assessed by the Pain Catastrophizing Scale	Participants will be sent a link to fill out the measure prior to starting their respective program, within 1 week of completing their respective program, and 1 month after completing their respective program.	A 13-item Likert scale (min possible score = 0, max possible score = 52). Higher scores indicate greater pain catastrophizing.

Trial Locations

Locations (1)

University Health Network- Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada