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Post-surgical PainADOPT-TPSNCT06455345

Online Psychology Program for Chronic Pain After Surgery

A study testing Self-Guided Online ACT Program and Treatment As Usual in people with Post-surgical Pain and Pain, Acute, run by University Health Network, Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Post-surgical Pain, Pain, Acute, Pain, Chronic
What is being tested?
Self-Guided Online ACT Program and Treatment As Usual
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesCanada
Study dates
20 Jan 2024to 31 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Toronto General Hospital- The Department of Anesthesia and Pain Management

    Toronto, Ontario, M5G 2N2

  • University Health Network- Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Self-Guided Online ACT Program, Treatment As Usual
Keywords
Feasibility Studies, Digital Health, Acceptance and Commitment Therapy, Mindfulness, Internet-based Intervention, Randomized Controlled Trial
Medical subject headings
Pain, Postoperative, Acute Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Guided Online ACT ProgramDevice

    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.

  • Treatment As UsualOther

    Also called Psychologist-guided online ACT

    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.

Study groups in NCT06455345
Study groupRoleWhat they receive
Self-guided Online ACTExperimentalThe 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.
Receives: Device: Self-Guided Online ACT Program
Psychologist-guided Online ACTActive comparatorThe psychologist-guided ACT group workshop is an evidence-based psychology intervention for chronic pain and opioid use after surgery.
Receives: Other: Treatment As Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. Retrospective Semi-structured Interview

    A brief interview with a randomized subset of participants

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

  4. 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

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

Secondary outcomes (8)
  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

  7. 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.

    Measured: 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.

  8. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start20 Jan 2024
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455345
Sponsor's protocol ID
23-5934
Other IDs
MSU-23-002
Acronym
ADOPT-TPS
Status last verified
Apr 2026
First submitted
27 Dec 2023
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Relevant de-identified study data will be shared upon request.

Publications

  • 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.

    PubMed 26508886
  • 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.

    PubMed 26241763
  • 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.

    PubMed 30586070
  • 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.

    PubMed 35496645
  • 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.

    PubMed 35005419
  • 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.

    PubMed 24519537
  • 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.

    PubMed 35005382
  • 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.

    PubMed 35005340
  • 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.

    PubMed 29777950
  • 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.

    PubMed 23548250
  • 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.

    PubMed 29704880
  • 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.

    PubMed 24993763
  • 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.

    PubMed 33892153
  • 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.

    PubMed 18165893
  • 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.

    PubMed 19345550

Questions about this trial

What is this clinical trial studying?

A study testing Self-Guided Online ACT Program and Treatment As Usual in people with Post-surgical Pain and Pain, Acute, run by University Health Network, Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455345, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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