Pain, Acute, Pain, Chronic, Post-surgical Pain, Post-Surgical Pain, Chronic
Conditions
Keywords
Feasibility Studies, Digital Health, Acceptance and Commitment Therapy, Mindfulness, Internet-based Intervention, Randomized Controlled Trial
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.
Interventions
DEVICESelf-Guided Online ACT Program
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.
OTHERTreatment As Usual
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.
Sponsors
University Health Network, Toronto
Academic Medical Organization of Southwestern Ontario
York University
Toronto General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Only the participants and the research coordinator will know which group (self-guided vs. psychologist-guided) an individual participant will be randomly assigned to.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORMaxwell Slepian, PhD, C Psych
Toronto General Hospital
Outcome results
None listed