Online Psychology Program for Chronic Pain After Surgery

Pain, Acute Clinical Trial

— ADOPT-TPS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455345
• Other study ID #: 23-5934
• Secondary ID: MSU-23-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Maxwell P Lead Clinical Health Psychologist, PhD, C Psych
• Phone: (416) 340-4800
• Email: maxwell.slepian[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Acute
• Pain, Chronic
• Pain, Postoperative
• Post-surgical Pain

Intervention

Device:
• Self-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.

Other:
• Treatment 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.

Locations

Country	Name	City	State
Canada	University Health Network- Toronto General Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Academic Medical Organization of Southwestern Ontario, Toronto General Hospital, York University

Country where clinical trial is conducted

Canada, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

van de Graaf DL, Trompetter HR, Smeets T, Mols F. Online Acceptance and Commitment Therapy (ACT) interventions for chronic pain: A systematic literature review. Internet Interv. 2021 Oct 1;26:100465. doi: 10.1016/j.invent.2021.100465. eCollection 2021 Dec. — View Citation

Veehof MM, Oskam MJ, Schreurs KMG, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011 Mar;152(3):533-542. doi: 10.1016/j.pain.2010.11.002. Epub 2011 Jan 19. — View Citation

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

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

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