NCT04509154

Effectiveness of the Multicomponent Therapy in Chronic Pain Through The Use of Smartphones

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Catastrophization
• Chronic Pain
• Pain, Chronic
• Cognitive Therapy
• Smartphones
• Acceptance, Social

Interventions

Type	Name	Description
OTHER	Multimodal pain therapy	For the elaboration of the contents of the multi-component treatment of the mobile device application (APP), a set of guidelines has been developed for the care of one's own health, based on scientific evidence and adapted to the language of citizens, applying participatory methodology (Loewenson et al. 2014) and consensus, both by professionals (physicians,, nurses, psychologists, pharmacists, social educators and health professionals), and expert patients, who guarantee their validity, allowing the analysis and selection of the interventions that respond to the health problem. This intervention consists in the implementation of a protocol of standard activities of the interactive psychosocial therapy type.
OTHER	Standardized treatment.	Face-to-face health education sessions led by nurses and physicians, with the possibility to have access to a non-interactive website with pain management materials from a self-help approach.

Timeline

• Start date: 2017-10-30
• Primary completion: 2019-03-30
• Completion: 2020-03-30
• First posted: 2020-08-11
• Last updated: 2020-08-14

Locations

1 site across 1 country: Spain