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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percentage of Participants who Attend More than Half of Scheduled Sessions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) (Behavioral)
结局指标
主要结局
Percentage of Participants who Attend More than Half of Scheduled Sessions
时间窗: Up to Week 8 (End of Intervention)
Client Satisfaction Questionnaire (CSQ-8) Score
时间窗: 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.
次要结局
- Change in Pain Catastrophizing Scale (PCS) Score(Baseline, Week 8)