Back PainPREPSNCT06750874
Perioperative ACT for Preventing CPSP
A study testing Acceptance and Commitment Therapy in people with Back Pain and Spinal Stenosis, run by Samantha Meints at 1 site in United States.
Trial summary
The present study aims to adapt and modify a brief perioperative 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
- Back Pain, Spinal Stenosis, Spondylosis
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 30 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: Feasibility and Acceptability of a Single-session Perioperative Acceptance and Commitment Therapy (ACT) Workshop for Preventing Chronic Postsurgical Pain: A Single-arm, Non-randomized Pilot Trial
The present study aims to adapt and modify a brief perioperative 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 assess the acceptability, feasibility, and preliminary efficacy of the intervention via a non-randomized, non-controlled pilot trial.
- Conditions
- Back Pain, Spinal Stenosis, Spondylosis, Spondylolisthesis, Back Injury
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- acceptance and commitment therapy, chronic postsurgical pain, ACT
- Medical subject headings
- Back Pain, Spinal Stenosis, Spondylosis, Spondylolisthesis, Back Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
One day workshop + telephone booster
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Acceptance and Commitment Therapy Workshop | Experimental | Participants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment helpfulness (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 (9)
Treatment Helpfulness (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
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
Pain Interference
Assesses how much a person's pain impacts their daily activities, including general activity, mood, walking, work, relationships with others, enjoyment of life, and sleep, with higher scores indicating greater interference with daily functioning due to pain. Each of the seven domains is rated on a scale from 0 (no interference) to 10 (complete interference), and the average score across these domains represents the overall pain interference level.
Measured: 1 month post-op
Pain Interference
The Brief Pain Inventory assesses how much a person's pain impacts their daily activities, including general activity, mood, walking, work, relationships with others, enjoyment of life, and sleep, with higher scores indicating greater interference with daily functioning due to pain. Each of the seven domains is rated on a scale from 0 (no interference) to 10 (complete interference), and the average score across these domains represents the overall pain interference level.
Measured: 3 months post-op
Pain Interference
The Brief Pain Inventory assesses how much a person's pain impacts their daily activities, including general activity, mood, walking, work, relationships with others, enjoyment of life, and sleep, with higher scores indicating greater interference with daily functioning due to pain. Each of the seven domains is rated on a scale from 0 (no interference) to 10 (complete interference), and the average score across these domains represents the overall pain interference level.
Measured: 6 months post-op
Pain Severity
The Brief Pain Inventory (BPI) measures pain severity by asking patients to rate their "worst pain" on a scale from 0 to 10, where a higher score indicates greater pain intensity
Measured: 1 month post-op
Pain Severity
The Brief Pain Inventory (BPI) measures pain severity by asking patients to rate their "worst pain" on a scale from 0 to 10, where a higher score indicates greater pain intensity
Measured: 3 months post-op
Pain Severity
The Brief Pain Inventory (BPI) measures pain severity by asking patients to rate their "worst pain" on a scale from 0 to 10, where a higher score indicates greater pain intensity
Measured: 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start4 Jan 2023
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, non-controlled pilot trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samantha Meints
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor-investigator, Samantha Meints, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750874
- Sponsor's protocol ID
- 2020A003336
- Other IDs
- K23AR077088
- Acronym
- PREPS
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Single-session Perioperative Acceptance and Commitment Therapy (ACT) Workshop for Preventing Chronic Postsurgical Pain: A Single-arm, Non-randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT06750874
- Acronym / sponsor ID
- PREPS / 2020A003336
- Conditions
- Back Pain, Spinal Stenosis, Spondylosis, Spondylolisthesis, Back Injury
- Keywords
- acceptance and commitment therapy, chronic postsurgical pain, ACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Samantha MeintsUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 27 Dec 2024 (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 perioperative 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 assess the acceptability, feasibility, and preliminary efficacy of the intervention via a non-randomized, non-controlled pilot trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, non-controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Perioperative Acceptance and Commitment Therapy Workshop | Experimental | Behavioral: Acceptance and Commitment TherapyParticipants assigned to this arm will complete a 1-day ACT workshop followed by a telephone booster after surgery |
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 |
|---|---|---|
| Acceptance and Commitment TherapyOne day workshop + telephone booster | Behavioural | Perioperative Acceptance and Commitment Therapy Workshop |
Primary outcome
Treatment helpfulness (THQ)
Time frame: Immediately following the ACT workshop
Item assesses the perceived helpfulness of the ACT workshop and is rated from -5 (extremely harmful) to 5 (extremely helpful).
9 secondary outcomes
Treatment Helpfulness (THQ)
Time frame: 1 month post-op
Treatment Credibility
Time frame: immediately following ACT workshop
Treatment Expectancy
Time frame: immediately following ACT workshop
Pain Interference
Time frame: 1 month post-op
Pain Interference
Time frame: 3 months post-op
Pain Interference
Time frame: 6 months post-op
Pain Severity
Time frame: 1 month post-op
Pain Severity
Time frame: 3 months post-op
Pain Severity
Time frame: 6 months post-op
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 1 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared.
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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 Acceptance and Commitment Therapy in people with Back Pain and Spinal Stenosis, run by Samantha Meints 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 1 May 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 (THQ) (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 1 May 2026.