跳至主要内容
临床试验/NCT04889300
NCT04889300已完成不适用

Resilience Factors and Selective Learning in Patients With Fibromyalgia

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2021年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
1
主要终点
Positive Affect

研究概览

简要总结

Learning impairments (such as reduced selective learning or excessive generalization) in the context of pain can lead to disability. Learning deficits have been found in experimental studies in various pain populations. In current scientific discussions, the activation of resilience factors (in particular positive affect and optimism) is being considered to optimize learning experiences and to make therapeutic procedures more effective. Positive affect could promote selective learning since positive emotions broaden attention and focus and thus possibly improve inhibitory learning. There is first scientific evidence for improved safety learning through positive affect in non-clinical samples in the context of pain. In this research project, the influence of positive affect and optimism on selective learning will be investigated in a clinical sample of fibromyalgia patients. Data will be collected online and standardized questionnaires will be used.

The authors expect that (1) There will be a larger increase in positive affect and positive future expectations in the Best Possible Self condition than in the Typical Day condition. (2) Patients in the Best Possible Self condition will show elevated positive affect and positive future expectations after the intervention compared to patients in the Typical Day condition. (3) And crucially, patients in the Best Possible Self condition will show better selective learning than patients in the Typical Day group. Thus the investigators hypothesize that the blocking effect will be higher for patients with higher degrees of positive affect and optimism.

详细描述

Selective learning will be experimentally investigated by using the blocking procedure. The blocking effect is one mechanism that can provide information about selective learning. In this procedure, one event (A+) will be first paired with pain. Participants should learn the relation between this event and the occurrence of pain. After, another event (x), i.e. the blocking stimulus, is displayed with the first event A (AX+). The combination of both events will also be associated with pain. It will be tested, to which extent participants expect pain for the blocking stimulus alone. In case of "blocked", i.e. reduced pain expectation for X we can assume adaptive, selective learning.

In the planned study a fictitious diary of a fibromyalgia patient will be used as "cover story". Different events and the words "pain" or "no pain" will be visually presented together, indicating in which situation pain occurs and in which not. Participants will be asked to imagine that they are the practitioner trying to learn which situations are associated with pain. This learning experiment is based on a former study by Meulders and colleagues, in which selective learning was investigated by presenting fictitious diary entries, such as "Kim was walking her dog" or "the weather was bad today" (CS) and pairing the sentences in terms of the blocking procedure (see above). In the central test phase, in which events were presented without pain report, participants were asked to give their pain expectations for the different situations. Deficits in selective learning were found in fibromyalgia patients compared to healthy control. For the planned study this learning paradigm will be used with minor adaptations (translated to German, minor instruction adaptations, renamed scale ends, higher scale resolution). The learning experiment will take about 15 minutes.

Positive affect and optimism will be induced through the Best Possible Self (BPS) Intervention. Subjects will be randomly assigned to either the optimism condition or a control condition.

The whole study will be conducted online. Participants will be asked to switch from the experimental platform to the questionnaire platform at various times. In order to recreate the laboratory situation and to keep participants engaged, we implemented several videos in which the virtual investigator guides participants throughout the experiment.

The sample size should include 164 participants, assuming a small effect. A priori power analyses were calculated with the software program G*Power for ANOVA with repeated measures, within-between interaction with a small effect (f=0.1, Power 0.8, α=0.05).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • self-reported fibromyalgia diagnosis
  • access to a computer or laptop with audio output

排除标准

  • other impairments that affect cognitive performance (e.g. stroke or brain damages)

结局指标

主要结局

Positive Affect

时间窗: immediately after the blocking procedure

Positive Affect will be measured with the Positive and Negative Affect Schedule (PANAS; Breyer \& Bluemke, 2016). It will be tested if affect is stable from immediate postvisualization to end of the experiment.

State Optimism/Positive Future Expectancies

时间窗: immediately after the blocking procedure

State Optimism/Positive Future Expectancies will be measured with the future expectancies scale (FEX; Hanssen et al., 2013; Peters, Vieler, \& Lautenbacher, 2016). It will be tested if state optimism is stable from immediate postvisualization to end of the experiment.

Pain expectancy/contingency awareness test phase

时间窗: post-intervention (immediately after the intervention)

Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for X, B, and Z. In case of "blocked", i.e. reduced pain expectation for X in the test phase we can assume adaptive, selective learning.

Pain expectancy/contingency awareness elemental acquisition phase

时间窗: Pain-expectancy will be measured in the practice phase before the intervention

Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the stimuli A+ and Z-.

Pain expectancy/contingency awareness reminder of acquisition phase

时间窗: post-intervention (immediately after the intervention)

Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the stimuli A+ and Z-.

Pain expectancy/contingency awareness compound acquisition phase

时间窗: post-intervention (immediately after the intervention)

Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the stimuli B+, AX+ and Z-.

Pain expectancy/contingency awareness pre-rating phase

时间窗: Pain-expectancy will be measured in the pre-rating phase before the intervention

Numerical Rating Scale (NRS; 0-100; 0 = expect not all, 100 = expect very much) It will be tested to which extent participants expect pain for the different stimuli which are used in the experiment (A, B, X, Z).

次要结局

  • Trait Optimism(pre-intervention (baseline))
  • chronic pain(immediately after the blocking procedure)
  • Depression(immediately after the blocking procedure)
  • Pain Catastrophizing(immediately after the blocking procedure)
  • Negative Affect(immediately after the blocking procedure)
  • Negative Future Expectancies(post-intervention (immediately after the intervention))

研究者

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

Jenny Riecke

Principal Investigator Jenny Riecke

Philipps University Marburg Medical Center

研究点 (1)

Loading locations...

相似试验