Online Psychology Program for Chronic Pain After Surgery

NCT06455345 | Completed

• 2 other identifiers: 23-5934MSU-23-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (4)

• Feasibility of the online ACT program as assessed by the Feasibility Survey

  A 10-item Likert scale (min possible score = 10, max possible score = 70). Higher scores indicate greater feasibility.

  Participants will be sent a link to fill out the measure within 1 week of completing their respective program.

• Acceptability of the online ACT program as assessed by the Treatment Evaluation Inventory - Short Form

  A 9-item Likert scale (min possible score = 9, max possible score = 45). Higher scores indicate greater acceptability.

  Participants will be sent a link to fill out the measure within 1 week of completing their respective program.

• Retrospective Semi-structured Interview

  A brief interview with a randomized subset of participants

  Participants will be sent an invitation for an interview within 1 month after completing their respective program

• Treatment Adherence as assessed by the Integration of ACT Skills Survey

  A 5-item Likert scale (min possible score = 5, max possible score = 35). Higher scores indicate greater treatment adherence

  Participants will be sent a link to complete the measure within 1 month after completing their respective program.

Secondary Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Self-guided Online ACT

EXPERIMENTAL

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.

Device: Self-Guided Online ACT Program

Psychologist-guided Online ACT

ACTIVE COMPARATOR

The psychologist-guided ACT group workshop is an evidence-based psychology intervention for chronic pain and opioid use after surgery.

Other: Treatment As Usual

Interventions

Self-Guided Online ACT Program DEVICE

Participants will be invited to access the ACT program on the Manage My Pain (MMP) app. Participants will follow the instructions in the app to complete the program in a self-paced manner. The program includes psychoeducational materials, guided mindfulness meditations, and self-reflection activities.

Self-guided Online ACT

Treatment As Usual OTHER

Participants will be invited to join a one-session ACT group workshop guided by a psychologist. The session will take place virtually using video call software. The psychologist will guide participants through the workshop agenda, which will include psychoeducational material, guided mindfulness meditations, and partaking in voluntary discussions with other group members.

Also known as: Psychologist-guided online ACT

Psychologist-guided Online ACT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• York University: collaborator
• Academic Medical Organization of Southwestern Ontario: collaborator
• Toronto General Hospital: collaborator

Study Sites (2)

Toronto General Hospital- The Department of Anesthesia and Pain Management

Toronto, Ontario, M5G 2N2, Canada

Location

University Health Network- Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (22)

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  BACKGROUND

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Related Links

• The home webpage for ManagingLife, the company that will host the ACT For My Pain intervention on the digital application (Manage My Pain).

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Maxwell Slepian, PhD, C Psych

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Only the participants and the research coordinator will know which group (self-guided vs. psychologist-guided) an individual participant will be randomly assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: June 12, 2024
• Study Start: January 20, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will become available after primary outcomes manuscript is published and will remain available for 10 years.
• Access Criteria: Request for access will be reviewed by the principle investigator and the study team and will be granted in accordance with University Health Network policies.

Locations

CA (2)