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| ID | Type | Description | Link |
|---|---|---|---|
| MSU-23-002 | Other Grant/Funding Number | Academic Health Sciences Centre - Innovation Fund |
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| Name | Class |
|---|---|
| Academic Medical Organization of Southwestern Ontario | OTHER |
| York University | OTHER |
| Toronto General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity as assessed by the Pain Numerical Rating Scale | A 4-item Likert scale (min possible score = 0, max possible score = 40). Higher scores indicate greater pain intensity. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maxwell Slepian, PhD, C Psych | Toronto General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital- The Department of Anesthesia and Pain Management | Toronto | Ontario | M5G 2N2 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26508886 | Background | Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015. | |
| 26241763 |
| Label | URL |
|---|---|
| The home webpage for ManagingLife, the company that will host the ACT For My Pain intervention on the digital application (Manage My Pain). | View source |
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Relevant de-identified study data will be shared upon request.
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The data will become available after primary outcomes manuscript is published and will remain available for 10 years.
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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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Only the participants and the research coordinator will know which group (self-guided vs. psychologist-guided) an individual participant will be randomly assigned to.
|
| 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. |
|
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| Pain Interference as assessed by the PROMIS Pain Interference Scale - Short Form 8a | A 8-item Likert scale (min possible score = 8, max possible score = 40). Higher scores indicate greater pain interference. | 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 | A 7-item Likert scale (min possible score = 7, max possible score = 5). Higher scores indicate greater pain medication misuse. | 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 | A 13-item Likert scale (min possible score = 0, max possible score = 52). Higher scores indicate greater pain catastrophizing. | 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 | A 8-item Likert scale (min possible score = 8, max possible score = 40). Higher scores indicate greater depressive symptoms. | 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. |
| Anxiety symptoms as assessed by the PROMIS Emotional Distress - Anxiety - Short Form 8A | A 8-item Likert scale (min possible score = 8, max possible score = 40). Higher scores indicate greater anxiety symptoms. | 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. |
| Psychological Inflexibility in Pain as measured by the Psychological Inflexibility in Pain Scale | A 16-item Likert scale (min possible score = 16, max possible score = 112). Higher scores indicate greater psychological inflexibility in pain. | 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. |
| Use of Study Platform as assessed by the Use of Manage My Pain Platform Survey | A 5-item Likert scale (min possible score = 4, max possible score = 20). Higher scores indicate more frequent use of the platform. | 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. |
| University Health Network- Toronto General Hospital |
| Toronto |
| Ontario |
| M5G 2N2 |
| Canada |
| Background |
| Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319. |
| 30586070 | Background | Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413. |
| 35496645 | Background | Rosenberger DC, Pogatzki-Zahn EM. Chronic post-surgical pain - update on incidence, risk factors and preventive treatment options. BJA Educ. 2022 May;22(5):190-196. doi: 10.1016/j.bjae.2021.11.008. Epub 2022 Feb 24. No abstract available. |
| 35005419 | Background | Katz J, Weinrib AZ, Clarke H. Chronic postsurgical pain: From risk factor identification to multidisciplinary management at the Toronto General Hospital Transitional Pain Service. Can J Pain. 2019 Jul 30;3(2):49-58. doi: 10.1080/24740527.2019.1574537. eCollection 2019. |
| 24519537 | Background | Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251. |
| 35005382 | Background | Clarke H, Azargive S, Montbriand J, Nicholls J, Sutherland A, Valeeva L, Boulis S, McMillan K, Ladak SSJ, Ladha K, Katznelson R, McRae K, Tamir D, Lyn S, Huang A, Weinrib A, Katz J. Opioid weaning and pain management in postsurgical patients at the Toronto General Hospital Transitional Pain Service. Can J Pain. 2018 Aug 20;2(1):236-247. doi: 10.1080/24740527.2018.1501669. eCollection 2018. |
| 35005340 | Background | Abid Azam M, Weinrib AZ, Montbriand J, Burns LC, McMillan K, Clarke H, Katz J. Acceptance and Commitment Therapy to manage pain and opioid use after major surgery: Preliminary outcomes from the Toronto General Hospital Transitional Pain Service. Can J Pain. 2017 Jun 28;1(1):37-49. doi: 10.1080/24740527.2017.1325317. eCollection 2017. |
| 29777950 | Background | Dindo L, Zimmerman MB, Hadlandsmyth K, StMarie B, Embree J, Marchman J, Tripp-Reimer T, Rakel B. Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. J Pain. 2018 Oct;19(10):1211-1221. doi: 10.1016/j.jpain.2018.04.016. Epub 2018 May 17. |
| 23548250 | Background | Buhrman M, Skoglund A, Husell J, Bergstrom K, Gordh T, Hursti T, Bendelin N, Furmark T, Andersson G. Guided internet-delivered acceptance and commitment therapy for chronic pain patients: a randomized controlled trial. Behav Res Ther. 2013 Jun;51(6):307-15. doi: 10.1016/j.brat.2013.02.010. Epub 2013 Mar 14. |
| 29704880 | Background | Scott W, Chilcot J, Guildford B, Daly-Eichenhardt A, McCracken LM. Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom. Eur J Pain. 2018 Apr 28. doi: 10.1002/ejp.1236. Online ahead of print. |
| 24993763 | Background | Hayes S, Hogan M, Dowd H, Doherty E, O'Higgins S, Nic Gabhainn S, MacNeela P, Murphy AW, Kropmans T, O'Neill C, Newell J, McGuire BE. Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial. BMJ Open. 2014 Jul 2;4(7):e005092. doi: 10.1136/bmjopen-2014-005092. |
| 33892153 | Background | Trindade IA, Guiomar R, Carvalho SA, Duarte J, Lapa T, Menezes P, Nogueira MR, Patrao B, Pinto-Gouveia J, Castilho P. Efficacy of Online-Based Acceptance and Commitment Therapy for Chronic Pain: A Systematic Review and Meta-Analysis. J Pain. 2021 Nov;22(11):1328-1342. doi: 10.1016/j.jpain.2021.04.003. Epub 2021 Apr 20. |
| 18165893 | Background | Cuijpers P, van Straten A, Andersson G. Internet-administered cognitive behavior therapy for health problems: a systematic review. J Behav Med. 2008 Apr;31(2):169-77. doi: 10.1007/s10865-007-9144-1. |
| 19345550 | Background | Fox MP. A systematic review of the literature reporting on studies that examined the impact of interactive, computer-based patient education programs. Patient Educ Couns. 2009 Oct;77(1):6-13. doi: 10.1016/j.pec.2009.02.011. Epub 2009 Apr 3. |
| 29320375 | Background | Lin J, Klatt LI, McCracken LM, Baumeister H. Psychological flexibility mediates the effect of an online-based acceptance and commitment therapy for chronic pain: an investigation of change processes. Pain. 2018 Apr;159(4):663-672. doi: 10.1097/j.pain.0000000000001134. |
| 29481976 | Background | Simister HD, Tkachuk GA, Shay BL, Vincent N, Pear JJ, Skrabek RQ. Randomized Controlled Trial of Online Acceptance and Commitment Therapy for Fibromyalgia. J Pain. 2018 Jul;19(7):741-753. doi: 10.1016/j.jpain.2018.02.004. Epub 2018 Mar 2. |
| 31200768 | Background | Lin J, Scott W, Carpenter L, Norton S, Domhardt M, Baumeister H, McCracken LM. Acceptance and commitment therapy for chronic pain: protocol of a systematic review and individual participant data meta-analysis. Syst Rev. 2019 Jun 14;8(1):140. doi: 10.1186/s13643-019-1044-2. |
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| Background | Weinrib A, Azam MA, Latman VV, Janmohamed T, Clarke H, Katz J. Manage My Pain: A Patient-Driven Mobile Platform to Prevent and Manage Chronic Postsurgical Pain. Novel Applications of Virtual Communities in Healthcare Settings. doi:10.4018/978-1-5225-2958-3.ch004 |
| 33117557 | Background | Slepian PM, Peng M, Janmohamed T, Kotteeswaran Y, Manoo V, Blades AM, Fiorellino J, Katznelson R, Tamir D, McRae K, Kahn M, Huang A, Kona S, Thaker S, Weinrib A, Katz J, Clarke H. Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. Digit Health. 2020 Oct 13;6:2055207620962297. doi: 10.1177/2055207620962297. eCollection 2020 Jan-Dec. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |