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临床试验/NCT06368362
NCT06368362已完成不适用

The Effectiveness and Mediators of Cognitive Bias Modification for Interpretation in the Reduction of Negative Emotional Response to Pain in Individuals With Chronic Musculoskeletal Pain

University of Southampton1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年11月17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
84
试验地点
1
主要终点
Emotional response to pain-related images

研究概览

简要总结

Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals.

详细描述

This study investigated whether Cognitive Bias Modification for Interpretation (CBM-I) could reduce negative emotional response to pain and to pain-related images, and whether reductions in interpretation bias (IB) and fear of pain mediated this effect. Participants with chronic musculoskeletal pain (N = 41) were randomised to benign CBM-I or no CBM-I, and healthy participants (N = 41) were randomised to benign CBM-I or pain-related CBM-I. After CBM-I, the study assessed pain-related IB and fear of pain, as well as negative emotional response to exercise-induced pain and images of musculoskeletal pain.

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 are not informed of the conditioned they are randomised to in this psychological intervention.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Chronic pain group Inclusion criteria
  • •Experience musculoskeletal pain (pain in muscles, bones, joints, tendons, or ligaments) that has lasted for at least the last 3 months before enrolment in the study
  • •Have visited a healthcare professional for their pain
  • •Aged 18-70 years
  • •Normal or corrected to normal vision
  • •Fluency in the English language

排除标准

  • •Any known reading difficulty
  • •Healthy group Inclusion criteria
  • •Aged 18-70 years
  • •Normal or corrected to normal vision
  • •Fluency in the English language Exclusion criteria
  • •Experience frequent or continuous pain for the past three months before enrolment in the study
  • •Currently experiencing pain
  • •Any known reading difficulty

研究组 & 干预措施

Benign CBM-I - Chronic pain

Experimental

Chronic pain participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios.

干预措施: Benign cognitive bias modification for interpretation (Behavioral)

No CBM-I - Chronic pain

No Intervention

Chronic pain participants randomised to the 'no CBM-I' condition complete the Ambiguous Situations Task without any form of bias modification.

Benign CBM-I - Healthy

Experimental

Healthy participants randomised to receive benign CBM-I, which uses the Ambiguous Situations Task to train participants to neutral meanings of ambiguous scenarios.

干预措施: Benign cognitive bias modification for interpretation (Behavioral)

Pain-related CBM-I - Healthy

Other

Healthy participants randomised to receive pain-related CBM-I, which uses the Ambiguous Situations Task to train participants to painful meanings of ambiguous scenarios.

干预措施: Pain-related cognitive bias modification for interpretation (Behavioral)

结局指标

主要结局

Emotional response to pain-related images

时间窗: Immediately post-intervention

Participants were presented twenty pain-related images, and asked to rate the extent to which they felt negative emotions while viewing the image. After a fixation cross presented for 500 ms, a pain-related picture was presented for 6000 ms. This was followed by another cross presented for 500 ms then numbers from 0 (not at all negative) to 10 (very negative) was displayed. Participants were instructed to look at the picture on the screen then to rate their negative emotion from 0 (not at all negative) to 10 (very negative). The mean rating of emotional response to pain-related images was calculated for each participant.

Emotional response to exercise induced pain

时间窗: Immediately post-intervention

Sensory and emotional pain words from the McGill Pain Questionnaire (MPQ) were presented, grouped as they are on the MPQ. Participants chose one word from each group most representing the pain experienced performing a dynamic arm exercise (rotating their arms in small circles forwards for 10 seconds then backwards for 10 seconds, repeating the process as many times as possible). Participants rated each word from 0 (not at all representative) to 10 (extremely representative) or indicated if none represented their exercise pain. Emotional response to exercise pain was calculated from intensity and representativeness scores. For intensity, words were assigned a numeric score according to MPQ instructions and summed for emotional and sensory words. For representativeness, mean rating of representativeness was calculated for sensory and emotional pain words. The sensory score was subtracted from the emotional score to compute emotional response to pain relative to the sensory experience.

次要结局

  • Pain interference(Baseline)
  • Fear of Pain(Immediately post-intervention)
  • Depression(Baseline)
  • Pain severity(Baseline)
  • Anxiety(Baseline)
  • Pain-related interpretation bias index(Immediately post-intervention)
  • Emotional response to average clinical pain(Immediately post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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