Pain
Conditions
Brief 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). Subjects will then be followed for two weeks postoperatively.
Interventions
BEHAVIORALTelephone-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
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Attend More than Half of Scheduled Sessions | Up to Week 8 (End of Intervention) | — |
| Client Satisfaction Questionnaire (CSQ-8) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Catastrophizing Scale (PCS) Score | Baseline, Week 8 | 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. |
Countries
United States
Outcome results
None listed