Clinical trial NCT06455345: Online Psychology Program for Chronic Pain After Surgery
Official title: Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS): Pilot Feasibility and Efficacy Randomized-Controlled Trial of a Scalable, Online Psychology Intervention for Post-Surgical Pain and Opioid Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-surgical Pain
Pain, Acute
Pain, Chronic
Post-Surgical Pain, Chronic
Keywords: Feasibility Studies
Digital Health
Acceptance and Commitment Therapy
Mindfulness
Internet-based Intervention
Randomized Controlled Trial
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
name: York University
name: Toronto General Hospital
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study will evaluate whether the self-guided online ADOPT-TPS tool is a the feasible and efficacious intervention compared to the psychologist-guided group workshop.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Feasibility of the online ACT program as assessed by the Feasibility Survey
timeFrame: Participants will be sent a link to fill out the measure within 1 week of completing their respective program.
measure: Acceptability of the online ACT program as assessed by the Treatment Evaluation Inventory - Short Form
timeFrame: Participants will be sent a link to fill out the measure within 1 week of completing their respective program.
measure: Retrospective Semi-structured Interview
timeFrame: Participants will be sent an invitation for an interview within 1 month after completing their respective program
measure: Treatment Adherence as assessed by the Integration of ACT Skills Survey
timeFrame: Participants will be sent a link to complete the measure within 1 month after completing their respective program.
Secondary outcomes:
measure: Pain Intensity as assessed by the Pain Numerical Rating Scale
timeFrame: 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.
measure: Pain Interference as assessed by the PROMIS Pain Interference Scale - Short Form 8a
timeFrame: 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.
measure: Pain Medication Misuse as assessed by the PROMIS Prescription Pain Medication Misuse Scale - Short Form 7a
timeFrame: 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.
measure: Pain Catastrophizing as assessed by the Pain Catastrophizing Scale
timeFrame: 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.
measure: Depressive symptoms as assessed by PROMIS Emotional Distress - Depression - Short Form 8b
timeFrame: 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.
measure: Anxiety symptoms as assessed by the PROMIS Emotional Distress - Anxiety - Short Form 8A
timeFrame: 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.
measure: Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale
timeFrame: 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.
measure: Use of Study Platform as assessed by the Use of Manage My Pain Platform Survey
timeFrame: 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.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network- Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: Maxwell Slepian, PhD, C Psych
role: PRINCIPAL_INVESTIGATOR
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