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临床试验/NCT07347704
NCT07347704已完成不适用

Evaluation of the Effectiveness of a Psychological Intervention for Fibromyalgia Supported by New Technologies

Universitat Jaume I1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年11月30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
发起方
入组人数
36
试验地点
1
主要终点
App' usability and acceptability

研究概览

简要总结

This study aims to evaluate the feasibility of a psychological intervention in patients diagnosed with Fibromyalgia supported by new technologies.

详细描述

Different therapeutic options for psychological intervention in fibromyalgia are currently available. However, these interventions are usually of a general nature and do not take into account the differences between patients.

On the other hand, we know that these programs have greater or lesser effectiveness in improving quality of life and adaptation to pain, but there is not as much information available regarding the therapeutic mechanisms that are related to this effectiveness, i.e., What variables mediate the improvement in therapy? When do they produce the change? Is it possible to adapt the interventions to the results of the same that we can receive in real time? In the present work we propose to apply a psychological treatment already validated for fibromyalgia emphasizing those variables of beliefs and coping that research has shown to be directly related to belonging to the group of higher or lower functionality.

The objective will be to find out, on the one hand, if it is feasible to monitor the change in therapy using new technologies and, on the other hand, to measure this change to consider it when implementing the intervention, which is traditionally quite manualized when performed at group level and hardly considers individual differences in the response to treatment during treatment. Specifically, by means of a validated App we will measure those therapeutic variables that we expect to change as a result of introducing the treatment and, if not, a series of alarms will be generated that will alert the clinician of the absence of the expected change so that he can adapt the intervention according to the evolution of the patient in real time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed with fibromyalgia

排除标准

  • Does not have a smartphone

研究组 & 干预措施

Cognitive Behavioral Therapy with app support

Experimental

A group intervention with a cognitive-behavioral approach of 8 sessions will be carried out. The intervention will focus on learning about the modulating factors of the pain experience and the acquisition of tools related to each of these factors.

干预措施: Cognitive Behavioral Therapy with app suport (Device)

结局指标

主要结局

App' usability and acceptability

时间窗: One administration one week after downloading the app

The System Usability Scale will be used to evaluate the perception that this tool is simple to use and useful. It is composed by 10 items which are responded according to a 5-point Likert scale (1 = "completely disagree" to 5 ="completely agree").

Feasibility of the app

时间窗: At the end of the study (9 weeks after study onset)

Feasibility of the study will be assessed by a calculation of responses completed from the assessments prompted.

次要结局

  • Changes in the Fibromyalgia Impact Questionnaire(Changes from Pretreatment to Posttreatment (9 weeks after study onset))
  • Changes in the Chronic Pain Coping Inventory-42(Changes from Pretreatment to Posttreatment (9 weeks after study onset))
  • Changes in the Survey of Pain Attitudes(Changes from Pretreatment to Posttreatment (9 weeks after study onset))
  • Changes in the Beck Depression Inventory(Changes from Pretreatment to Posttreatment (9 weeks after study onset))

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (1)

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