PainNCT05888025
MBCT-T for Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery
A study testing Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) in people with Pain, run by NYU Langone Health at 2 sites in United States.
Trial summary
This is a two phase study. In phase 1, a focus group (N=5) will be conducted to adapt MBCT-T for use in the study population. In phase 2, a single-arm trial will be conducted examining four, weekly sessions of preoperative MBCT-T in subjects with high pain catastrophizing scheduled for spine surgery (N=20). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jan 2020to Oct 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for one or two level lumbar spine surgery requiring an inpatient stay as well as patients having ambulatory 1 or 2 level lumbar spine surgeries
- PCS score ≥ 20
- Able to provide voluntary informed consent
- Telephone access
- Internet access
Who cannot join
- Non-English speaking
- Cognitively impaired, by history
- Bipolar disorder
- Borderline personality disorder
- Active post-traumatic stress disorder
- Schizoaffective disorder or any other disorder characterized by delusions or hallucinations
- History of self-harm or suicidality in past three months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Health
Brooklyn, New York, 11220
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Pilot Proof of Concept, Single-Center Study of the Effects of Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) on Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery
This is a two phase study. In phase 1, a focus group (N=5) will be conducted to adapt MBCT-T for use in the study population. In phase 2, a single-arm trial will be conducted examining four, weekly sessions of preoperative MBCT-T in subjects with high pain catastrophizing scheduled for spine surgery (N=20). Subjects will then be followed for two weeks postoperatively.
- Conditions
- Pain
- Being tested
- Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)Behavioural
MBCT-T will be delivered in groups of four to eight subjects by telephone using a conference line with NYULH WebEx. Participants will receive a workbook containing session content and home practice logs and audio guides for home practice. Subjects will complete individual orientation sessions with the MBCT-T facilitator prior to start of the group sessions. The four subsequent weekly group sessions are approximately 90 minutes long. Participants will be encouraged to practice daily meditation in between group sessions for 20-30 minutes, six days per week
| Study group | Role | What they receive |
|---|---|---|
| MBCT-T | Experimental | Participants with high pain catastrophizing who are scheduled for spine surgery will receive four weekly sessions of preoperative telephone-delivered mindfulness-based cognitive therapy (MBCT-T). They will then be followed for two weeks postoperatively. Receives: Behavioral: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Attend More than Half of Scheduled Sessions
Measured: Up to Week 8 (End of Intervention)
Client Satisfaction Questionnaire (CSQ-8) Score
The CSQ-8 is an 8-item questionnaire assessing satisfaction with the intervention. Each item is rated on a 4-point scale from 1-4. The total score is the sum of responses and ranges from 8 to 32, with the higher number indicating greater satisfaction.
Measured: Week 8 (End of Intervention)
Secondary outcomes (1)
Change in Pain Catastrophizing Scale (PCS) Score
The PCS is a 13-item questionnaire designed to quantify an individual's pain experience, asking about how they feel and what they think about when they are in pain. Each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (all the time). The total score is the sum of responses and ranges from 0 to 52. Higher scores represent greater pain catastrophizing.
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start9 Jan 2020
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: Temporarily suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Doan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888025
- Sponsor's protocol ID
- 19-00339
- Status last verified
- Jan 2026
- First submitted
- 25 May 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: lisa.doan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Proof of Concept, Single-Center Study of the Effects of Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) on Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery
- ClinicalTrials.gov ID
- NCT05888025
- Acronym / sponsor ID
- 19-00339
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporarily suspended.
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Jun 2023 (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.
This is a two phase study. In phase 1, a focus group (N=5) will be conducted to adapt MBCT-T for use in the study population. In phase 2, a single-arm trial will be conducted examining four, weekly sessions of preoperative MBCT-T in subjects with high pain catastrophizing scheduled for spine surgery (N=20). Subjects will then be followed for two weeks postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCT-T | Experimental | Behavioral: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)Participants with high pain catastrophizing who are scheduled for spine surgery will receive four weekly sessions of preoperative telephone-delivered mindfulness-based cognitive therapy (MBCT-T). They will then be followed for two weeks postoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled for one or two level lumbar spine surgery requiring an inpatient stay as well as patients having ambulatory 1 or 2 level lumbar spine surgeries
- PCS score ≥ 20
- Able to provide voluntary informed consent
- Telephone access
- Internet access
Key exclusion criteria (7 listed)
- Non-English speaking
- Cognitively impaired, by history
- Bipolar disorder
- Borderline personality disorder
- Active post-traumatic stress disorder
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 |
|---|---|---|
| Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)MBCT-T will be delivered in groups of four to eight subjects by telephone using a conference line with NYULH WebEx. Participants will receive a workbook containing session content and home practice logs and audio guides for home practice. Subjects will complete individual orientation sessions with the MBCT-T facilitator prior to start of the group sessions. The four subsequent weekly group sessions are approximately 90 minutes long. Participants will be encouraged to practice daily meditation in between group sessions for 20-30 minutes, six days per week | Behavioural | MBCT-T |
Primary outcome
Percentage of Participants who Attend More than Half of Scheduled Sessions
Time frame: Up to Week 8 (End of Intervention)
Client Satisfaction Questionnaire (CSQ-8) Score
Time frame: Week 8 (End of Intervention)
The CSQ-8 is an 8-item questionnaire assessing satisfaction with the intervention. Each item is rated on a 4-point scale from 1-4. The total score is the sum of responses and ranges from 8 to 32, with the higher number indicating greater satisfaction.
1 secondary outcome
Change in Pain Catastrophizing Scale (PCS) Score
Time frame: Baseline, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: lisa.doan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Lisa Doan, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) in people with Pain, run by NYU Langone Health at 2 sites 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 5 inclusion and 7 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: paused, as of the sponsor's last update on 6 Jan 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 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?
Results are not available in the source record.
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?
Percentage of Participants who Attend More than Half of Scheduled Sessions (time frame: Up to Week 8 (End of Intervention)). The study lists 2 primary outcomes in all. 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 6 Jan 2026.