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临床试验/NCT03146832
NCT03146832已完成不适用

Exposure Works, But How? Testing Different Therapeutic Strategies During Exposure to Pain in an Experimental Design

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2017年4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
139
试验地点
1
主要终点
Pain tolerance

研究概览

简要总结

The goal of the present study is to compare different therapeutic strategies (according to habituation model vs. according to the inhibitory learning approach) during exposure to thermal pain in an experimental design.

详细描述

Exposure therapy is effective for the treatment of individuals with chronic pain and high levels of fear-avoidance. Nevertheless, mechanisms of change for exposure treatment are not sufficiently investigated. According to the habituation model, the activation of a fear structure leads to a habituation of the initial physical response. Therefore, the therapeutic recommendation is to focus on the reduction of fear during exposure sessions. According to the inhibitory learning approach, however, exposure experiences compete with the original US-CS fear association. Therefore, the therapist should maximize the violation of negative expectancies. The present study intends to compare both strategies during the exposure to pain in an experimental design.

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
Single (Participant)

盲法说明

Participants were not aware which experimental condition they were allocated to.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •female gender
  • •sufficient knowledge of German language

排除标准

  • •chronic and acute pain conditions
  • •Raynaud's disease
  • •high blood pressure
  • •neuropathy, coronary diseases
  • •diabetes, current alcohol
  • •drug or pain-medication (last 24hours)

研究组 & 干预措施

Habituation

Experimental

The habituation instruction focuses on changes of the initial physical fear-responses during exposure sessions. It is explained that the level of anxiety will gradually decrease, or habituate, each time someone faces a feared situation. Participants are then instructed to observe their own level of fear during the three practice trials with the thermode. Together with the experimenter, participants have to indicate their level of arousal on an 11-point scale (0= neutral, 10 = very high) in-between and after the three practice trials. After the practice trial, participants are instructed to reconsider their own development of physical responses. Participants are encouraged to remember the development of their level of arousal during the test trail with the thermode.

干预措施: Exposure therapy (according to habituation approach) (Behavioral)

Expectation Violation

Experimental

The expectation violation instruction focuses on the verification of negative expectancies during exposures sessions. It is explained that exposure exercises help to create own experiences which allow to directly test negative predicted outcomes. Together with the experimenter, participants are then encouraged to formulate concrete concerns in regard to the practice trail with the thermode. Before the practice trails, participants have to indicate the likelihood of their concerns on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are instructed to evaluate their own concerns by some guided questions (e.g. "What did you learn?"). Participants are encouraged to keep their own experience in mind during the test trail with the thermode.

干预措施: Exposure therapy (according to inhibitory learning approach) (Behavioral)

Control

No Intervention

Participants in the control group are not provided with information about exposure therapy. Instead, participants listen to a newspaper article which reports on the daily work in a botanical garden. Together with the experimenter, participants are then asked to name the most interesting aspect in the article. Before the practice trails, participants have to rate how likely it is that they would further inform themselves about botanical gardens on an 11-point scale (0= not likely, 10 = very likely). After the practice trails, participants are provided with some further questions about the newspaper article (e.g. "Did you find the newspaper article interesting?"). This cognitive exercise does not cover any pain-related topics and, therefore, does not serve as a distraction instruction.

结局指标

主要结局

Pain tolerance

时间窗: 5 minutes prior and 5 minutes after three exposure practice trials

Determined by the temperature at which the participant stopped the heat stimulus

次要结局

  • Pain intensity(5 minutes prior and 5 minutes after three exposure practice trials)
  • Pain Catastrophizing Scale (PCS)(1-week prior and 10 minutes after three exposure practice trials)
  • Pain Anxiety Symptom Scale (PASS)(1-week prior and 10 minutes after three exposure practice trials)
  • Pain quality(5 minutes prior and 5 minutes after three exposure practice trials)
  • Pain Processing (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV)(1-week prior and 10 minutes after three exposure practice trials)
  • Psychophysiological activation(throughout the experiment (5 minutes prior, during and 10 minutes after three exposure practice trails)

研究者

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

Julia Anna Glombiewski

Ph.D, Licensed Psychologist, Principal Investigator

Philipps University Marburg Medical Center

研究点 (1)

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