Pain, BackPREPSNCT05306665
PREventing Pain After Surgery
A study testing ACT intervention in people with Pain, Back and Spinal Stenosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pain, Back, Spinal Stenosis, Disc Herniation
- What is being tested?
- ACT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
- age 22 and older
- able to communicate fluently in English
Who cannot join
- inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
- have a history of severe neurologic movement disorder
- are pregnant or intent to become pregnant during study
- have undergone previous spinal surgery
- have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
- have undergone Acceptance and Commitment Therapy in last 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 01467
About this study
Official title: PREventing Pain After Surgery: A Feasibility and Acceptability Study of Acceptance and Commitment Therapy for the Prevention of Chronic Post-surgical Pain (PREPS)
The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.
- Conditions
- Pain, Back, Spinal Stenosis, Disc Herniation, Spondylosis, Spondylolisthesis, Back Injuries
- Being tested
- ACT intervention
- Keywords
- Chronic pain, Surgery, opioid, acceptance and commitment therapy, Prevention
- Medical subject headings
- Back Pain, Spinal Stenosis, Intervertebral Disc Displacement, Spondylosis, Spondylolisthesis, Back Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT interventionBehavioural
One day in person workshop + telephone booster
| Study group | Role | What they receive |
|---|---|---|
| ACT intervention | Experimental | Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery Receives: Behavioral: ACT intervention |
| Treatment As Usual | No intervention | Participants assigned to this arm will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Helpfulness
Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).
Measured: Immediately following the ACT workshop
Secondary outcomes (12)
Pain Interference
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Items are rated from 1-5 and then summed with higher scores indicative of greater pain interference
Measured: 1 month post-op
Pain Interference
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Items are rated from 1-5 and then summed with higher scores indicative of greater pain interference
Measured: 3 months post-op
Pain Interference
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Items are rated from 1-5 and then summed with higher scores indicative of greater pain interference
Measured: 6 month post-op
Treatment Helpfulness
Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).
Measured: 1 month post-op
Opioid dose
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Measured: 1 month post-op
Opioid dose
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Measured: 3 months post-op
Opioid dose
We will assess daily morphine equivalent doses using the ManageMyPain App and confirm via medical record review
Measured: 6 months post-op
Pain Intensity
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Measured: 1 month post-op
Pain Intensity
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Measured: 3 months post-op
Pain Intensity
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29); Values range from 0-10 with higher scores indicating greater pain intensity
Measured: 6 months post-op
Treatment Credibility
Credibility and Expectancy Questionnaire (CEQ); 3 items are rated to indicate the logic, success, and confidence in the treatment. Scores are summed with a range from 3-27 where higher scores indicating greater treatment credibility
Measured: Immediately following ACT workshop
Treatment Expectancy
Credibility and Expectancy Questionnaire (CEQ); 3 items are used to assess the likelihood of the success of the therapy to reduce pain and improve function. Scores are summed with a range from 0-29 where higher scores indicate greater expectancy for beneficial treatment outcomes
Measured: Immediately following ACT workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start13 Jan 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, BackStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Meints, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306665
- Sponsor's protocol ID
- 2022P002302
- Acronym
- PREPS
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will be stripped of identifiers prior to release for sharing at the time of publication or shortly thereafter. The data will then be made available to approved outside collaborators under a data-sharing agreement that provides for (1) commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed. Further, the data will be shared via publication and/or public presentations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREventing Pain After Surgery: A Feasibility and Acceptability Study of Acceptance and Commitment Therapy for the Prevention of Chronic Post-surgical Pain (PREPS)
- ClinicalTrials.gov ID
- NCT05306665
- Acronym / sponsor ID
- PREPS / 2022P002302
- Conditions
- Pain, Back, Spinal Stenosis, Disc Herniation, Spondylosis, Spondylolisthesis, Back Injuries
- Keywords
- Chronic pain, Surgery, opioid, acceptance and commitment therapy, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT intervention | Experimental | Behavioral: ACT interventionParticipants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery |
| Treatment As Usual | No intervention | –Participants assigned to this arm will receive treatment as usual. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
- age 22 and older
- able to communicate fluently in English
Key exclusion criteria (6 listed)
- inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
- have a history of severe neurologic movement disorder
- are pregnant or intent to become pregnant during study
- have undergone previous spinal surgery
- have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT interventionOne day in person workshop + telephone booster | Behavioural | ACT intervention |
Primary outcome
Treatment Helpfulness
Time frame: Immediately following the ACT workshop
Treatment Helpfulness Questionnaire (THQ); Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).
12 secondary outcomes
Pain Interference
Time frame: 1 month post-op
Pain Interference
Time frame: 3 months post-op
Pain Interference
Time frame: 6 month post-op
Treatment Helpfulness
Time frame: 1 month post-op
Opioid dose
Time frame: 1 month post-op
Opioid dose
Time frame: 3 months post-op
Opioid dose
Time frame: 6 months post-op
Pain Intensity
Time frame: 1 month post-op
Pain Intensity
Time frame: 3 months post-op
Pain Intensity
Time frame: 6 months post-op
Treatment Credibility
Time frame: Immediately following ACT workshop
Treatment Expectancy
Time frame: Immediately following ACT workshop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. The final dataset will be stripped of identifiers prior to release for sharing at the time of publication or shortly thereafter. The data will then be made available to approved outside collaborators under a data-sharing agreement that provides for (1) commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed. Further, the data will be shared via publication and/or public presentations.
Related trials for Pain, Back
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT intervention in people with Pain, Back and Spinal Stenosis, run by Brigham and Women's Hospital at 1 site in United States.
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 3 inclusion and 6 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Treatment Helpfulness (time frame: Immediately following the ACT workshop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.