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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Catastrophization, Chronic Pain, Pain, Chronic, Cognitive Therapy, Smartphones, Acceptance, Social

Intervention / Treatment
-----------------
* Other: Multimodal pain therapy
* Other: Standardized treatment.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The design is based on a parallel group controlled randomized clinical trial experimental study (Kristjánsdóttir et al., 2011). Block randomization is used to ensure similar numbers in each group and by phase.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal pain therapy<br>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; 6 weeks after (8 weeks maximum after treatment) and three months just after having completed 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 of them.This program will be. | Other: Multimodal pain therapy<br>* 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.<br>* Other names: NO+PAIN ,SMARPHONE;|
| Experimental: Standardized treatment.<br>Both groups (control and intervention) received two face-to-face health education sessions led by nurses and physicians, and had access to a non-interactive web page with material for pain management from a self-help approach. | Other: Standardized treatment.<br>* 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.<br>* Other names: FACE-TO-FACE;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pain Catastrophization Scale (PCS) (Sullivan, Bishop and Pivik, 1995), Spanish adaptation of (J. García Campayo et al., 2008), | 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). | 6 MONTH | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pain Acceptance Questionnaire (CPAQ) (McCracken, Vowles, & Eccleston, 2004). Spanish adaptation by (Balluerka, Gorostiaga, Alonso-Arbiol, & Haranburu, 2007) | It was used to measure participation in activities of daily living despite pain and the willingness to experience pain without trying to control, alter or avoid it. It is a 20-item questionnaire that evaluates the acceptance of pain in a 6-point Likert-type format that goes from or (never true) to 6 (always true). The total CPAQ score is the sum of the two subscales. According to (GEISER, 1992), the initial studies carried out in relation to acceptance and adaptation to the CPAQ questionnaire, show adequate internal consistency and expected correlations with measures of physical functioning and psychological distress. After subsequent studies in which its content and dimensionality were evaluated (McCracken et al., 2004), two factors were established, the involvement in activities (Cronbach's α of 0.82) and the openness to pain (Cronbach's α of 0.78). . | 6 MONTH |