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临床试验/NCT03157622
NCT03157622已完成不适用

Comparing Therapeutic Change During Exposure and Cognitive-Behavioral Therapy in the Context Chronic Low Back Pain

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Therapeutic changes during the course of treatment compared to baseline

研究概览

简要总结

Exploration of treatment processes during exposure and cognitive-behavioral therapy in the context of chronic low back pain in a multiple baseline single-case design.

详细描述

The present study intends to specifically investigate treatment elements during exposure and cognitive-behavioral therapy, which are especially powerful in electing time contingent therapeutic change. hereby, it is the goal to explore further change processes, which play an important role during psychological treatment of individuals with CLBP and high levels of fear-avoidance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •> 6 months chronic low back pain
  • •Sufficient level on fear avoidance scores (PCS > 35, PASS >20, QBPDS > 30, PDI > 20 and Phoda harm ratings of 13 activities > 50, including 8 > 80)
  • •German-speaking
  • •Agreeing to participate, verified by completion of informed consent

排除标准

  • •Red flags
  • •Pregnancy
  • •Illiteracy
  • •Psychoses
  • •Alcohol addiction
  • •Surgeries during the last 6 months or planed surgeries
  • •Specific medical disorders or cardiovascular diseases preventing participation in physical exercise
  • •Participating in another psychotherapy

研究组 & 干预措施

Exposure in vivo

Active Comparator

In the Exposure in vivo (EXP) condition, patients are given a careful explanation of the fear-avoidance model. Patients are encouraged to adopt the model to their individual situation. Factors for the maintenance of chronic pain (such as pain cognitions and pain-related fear) are discussed. Especially, negative consequences of avoidance behavior are highlighted. In preparation of the exposure sessions, patients develop an individual fear hierarchy using the Photo Series of Daily Actives. Subsequently, patients are encouraged to test their fear-avoidance beliefs during behavioral experiments and to reduce avoidance behaviors during individually tailored exposure exercises.

干预措施: Exposure in vivo (Behavioral)

Cognitive Behavioral Psychotherapy

Active Comparator

In the Cognitive Behavioral Psychotherapy (CBT) condition, patients are introduced to several strategies to improve their pain management. The principle of graded activity encourages patients to re-engage in former activities by dividing these activities into smaller steps. Predetermined resting periods are offered as a form to prevent patients from phases of excessive demands followed by long terms of recovery. Progressive muscle relaxation is introduced as a technique to improve the experience of pain. The strategy of attention shifting is presented to change their perception of pain. Maladaptive pain-related cognitions are identified and challenged by cognitive interventions.

干预措施: Cognitive Behavioural Psychotherapy (Behavioral)

结局指标

主要结局

Therapeutic changes during the course of treatment compared to baseline

时间窗: from baseline phase (1-3 weeks) to intervention phase (5 weeks)

Specifically developed questionnaire on therapeutic change processes

次要结局

  • Pain severity at posttest and follow-up compared to baseline pain severity(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Pain-related anxiety at posttest and follow-up compared to baseline pain-related anxiety(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Pain catastrophizing thoughts at posttest and follow-up compared to baseline pain catastrophizing thoughts(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Perceived harmfulness of daily activities at posttest and follow-up compared to baseline perceived harmfulness of daily activities(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Pain-related avoidance behavior at posttest and follow-up compared to baseline pain-related avoidance behavior(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disability(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disability(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Emotional distress at posttest and follow-up compared to baseline emotional distress(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))
  • Biological stress markers distress at posttest and follow-up compared to baseline biological stress markers(from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julia Anna Glombiewski

Dr. Julia A. Glombiewski

Philipps University Marburg Medical Center

研究点 (1)

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