跳至主要内容
临床试验/NCT04509154
NCT04509154
已完成
不适用

"Effectiveness of Cognitive Behavioral Therapy Against Chronic Pain From a Gender Perspective Through Information Technology in the Southern Health Area of Córdoba

Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 100 人2017年10月30日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Catastrophization
发起方
Maimónides Biomedical Research Institute of Córdoba
入组人数
100
试验地点
1
主要终点
The Pain Catastrophization Scale (PCS) (Sullivan, Bishop and Pivik, 1995), Spanish adaptation of (J. García Campayo et al., 2008),
状态
已完成
最后更新
5年前

概览

简要总结

Chronic pain is one of the pathological processes with the greatest impact on the demand of health services. The cost of this process in Spain according to the results is 2.5% of Gross Domestic Product (Breivik, Collett, Ventafridda et al. 2006).Mainly affects women and in it psychological, behavioral and psychological factors converge (Cöster, Kendall, Gerdle et al. 2008). The role of gender as a social determinant of health is known (Stansfeld, 2006).

Multidisciplinary and not only pharmacological intervention stands as a desirable paradigm for addressing this type of health problem, and it is considered necessary to standardize treatment in this regard. Thus, psychological constructs such as the concept of "catastrophization" have demonstrated the relationship between suffering and the displacing experience (Wade, Riddle, Price, Dumenci, 2011) and the psychological framework of Acceptance and Commitment Therapy has also revealed its positive effect. .

The rise of new technologies makes it necessary to give added value to the use of digital mobile devices for its potential contribution to the health care of the population, given its immediacy, widespread use, possibility of interaction and increase of the margin of accessibility to health services.

The present project aims to demonstrate that multidisciplinary and combined intervention of pharmacological therapies with specific psychological therapies along with the use of mobile digital devices can improve the management and evolution of chronic pain.

详细描述

Patients received a written invitation from their primary care physician or nurse to a group informational meeting where the principal investigator introduced the program. The study has been completed in a span of three years. People participating in the study were asked to give their informed consent. To carry out this study, the basic ethical aspects have been guaranteed, approved by the Research Ethics Committee of Córdoba which belongs to the Andalusian Public Health System. The Informed consent was guaranteed by the Research Ethics Committee of Córdoba which belongs to the Andalusian Public Health System In the group meeting, the people who agree to participate in the study will be informed via email, they will be given instructions on how to download the mobile application if they are selected in the intervention group, the treatment will last 6 weeks maximum 8 weeks The three questionnaires will be completed by all study subjects in a maximum time of 10 minutes. Immediately after receiving the two face-to-face sessions. Then ,the questionnaire will be filled in again by participants at week number (8 weeks maximum after treatment) and three months just after having received the treatment. The pain management application includes automatic monitoring, skills training, social support, education, goal setting and achievement of 4 components: exercises, psychological well-being, pharmacological and health assets interventions. Every week participants have a look at digital presentations about every component, doing then 3 activities related to each.This program will be.

注册库
clinicaltrials.gov
开始日期
2017年10月30日
结束日期
2020年3月30日
最后更新
5年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Maimónides Biomedical Research Institute of Córdoba
责任方
Principal Investigator
主要研究者

Yolanda Morcillo

Effectiveness of Cognitive Behavioral Therapy Before Chronic Pain From a Gender Perspective Through Information Technology in the South Sanitary Area of Córdoba

Maimónides Biomedical Research Institute of Córdoba

入排标准

入选标准

  • The inclusion criteria for patients in this study were: patients ≥18 years of age presenting pain of any location, lasting ≥ 3 months, intensity ≥ 4 on the EVN (Numerical Visual Scale), and with one of the following characteristics: Continuous pain, Intermittent pain ≥ 5 days a week. Not be participating in another research project and with skills for the use of mobile telephony.

排除标准

  • Exclusion criteria included cancer patients, bipolar or psychotic disorder, a history of brain injury, inability to complete study forms due to mental disability or language barrier.

结局指标

主要结局

The Pain Catastrophization Scale (PCS) (Sullivan, Bishop and Pivik, 1995), Spanish adaptation of (J. García Campayo et al., 2008),

时间窗: 6 MONTH

it was used to measure the main outcome variable of the study: catastrophization in pain, which is considered an important prognostic factor in chronic pain in general. The PCS is a 13-item self-administered scale on a 5-point Likert-type scale ranging from 0 (never) to 4 (always). It comprises 3 dimensions: a) rumination; b) magnification, and c) hopelessness. Higher scores indicate higher levels of catastrophism. The Spanish version of the PCS has been shown to have adequate internal consistency, convergent validity, and classificatory value (Cronbach's α = 0.79), test-retest reliability (intraclass correlation coefficient = 0.84), and sensitivity to size change (effect size). \> 2), which makes it a good measure, similar to the original scale, so its use is aimed at clinical practice and clinical research (García-Campayo et al., 2008).

次要结局

  • The Pain Acceptance Questionnaire (CPAQ) (McCracken, Vowles, & Eccleston, 2004). Spanish adaptation by (Balluerka, Gorostiaga, Alonso-Arbiol, & Haranburu, 2007)(6 MONTH)

研究点 (1)

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