Online Psychology Program for Chronic Pain After Surgery (ADOPT-TPS)
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Maxwell P Lead Clinical Health Psychologist, PhD, C Psych
- Phone Number: 4251 (416) 340-4800
- Email: maxwell.slepian@uhn.ca
Study Contact Backup
- Name: Hance Director of Pain Services, MD, PhD
- Phone Number: 2927 416-340-4800
- Email: hance.clarke@uhn.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2N2
- University Health Network- Toronto General Hospital
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Toronto, Ontario, Canada, M5G 2N2
- Toronto General Hospital- The Department of Anesthesia and Pain Management
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Self-guided Online ACT
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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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.
|
|
Active Comparator: Psychologist-guided Online ACT
The psychologist-guided ACT group workshop is an evidence-based psychology intervention for chronic pain and opioid use after surgery.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the online ACT program as assessed by the Feasibility Survey
Time Frame: 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.
|
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
Time Frame: 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.
|
Participants will be sent a link to fill out the measure within 1 week of completing their respective program.
|
|
Retrospective Semi-structured Interview
Time Frame: 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
|
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
Time Frame: 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
|
Participants will be sent a link to complete the measure within 1 month after completing their respective program.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity as assessed by the Pain Numerical Rating Scale
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Maxwell Slepian, PhD, C Psych, Toronto General Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 23-5934
- MSU-23-002 (Other Grant/Funding Number: Academic Health Sciences Centre - Innovation Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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