Chronic Widespread Pain

NCT ID: NCT04942132

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2021-09-30

Brief Summary

Cognitive-behavioral treatments have proven effective in helping people with chronic pain. However, due to the limited availability of trained clinicians, many young people with chronic pain problems do not benefit from them. In order to overcome the shortage of clinicians researchers have begun to develop treatment programs that could be self-administered by smartphones. Although this is a step in the right direction, it is equally true that it also encloses a problematic issue. Namely, a large number of experienced clinicians would still be needed to oversee the functioning of these programs, and it does not seem likely that they will be available within a short time, at least in certain countries.

The objectives of this project are (1) to develop a web platform (iPAINs) to assist the clinician in the process of (a) creating and (b) administering cognitive-behavioral treatments for the management of chronic pain in adolescents and young adults, and (2) study the efficacy of a self-administered cognitive-behavioral treatment for young people with fibromyalgia or chronic widespread pain, developed and administered through iPAINs.

Detailed Description

iPAINs, will be a computer assisted device made to help create cognitive-behavioral treatment programs (and manage them) that can assist novice or expert professionals in the management of chronic pain in youths (experts who otherwise would not have the resources to develop and manage treatments via Smartphones). Therefore, it will help in the process of knowledge translation in this understudied and undertreated problem (of chronic pain in youths).

This platform (which includes an editor and administrator of treatments) will be evaluated in a sequential phased approach, consisting of 5 independent studies: (1) development of the tool and its contents (ie, digital objects of treatment), and (2) the web environment that allows creating and editing clinical treatments, (3) usability testing of iPAINs by a group of novice clinicians, and (4) experts clinicians to refine the prototype, and (5) a pilot study to determine the feasibility and effectiveness of the tool, that is, implementing a cognitive-behavioral self-administered treatment -through iPAINs- with patients with fibromyalgia or chronic widespread pain (Fibroline).

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

A Smartphone self-administered cognitive-behavioral based intervention

Group Type: EXPERIMENTAL

Cognitive-behavioral (CBT)

Intervention Type: BEHAVIORAL

Treatment includes a smartphone-delivered CBT program designed to improve the quality of life of individuals with chronic pain. The treatment is condensed in nine weeks, and contains the following modules or units of treatment: sleep quality, anxiety management, pain coping, medication use, physical conditioning, mood regulation, problem solving, decision-making and relationships with others. All the content and settings are written in Spanish.

Interventions

Cognitive-behavioral (CBT)

Treatment includes a smartphone-delivered CBT program designed to improve the quality of life of individuals with chronic pain. The treatment is condensed in nine weeks, and contains the following modules or units of treatment: sleep quality, anxiety management, pain coping, medication use, physical conditioning, mood regulation, problem solving, decision-making and relationships with others. All the content and settings are written in Spanish.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of fibromyalgia or chronic widespread pain
• Capable of understanding, reading and writing in Spanish

Exclusion Criteria

• Physical disabilities that interfered in the use of a Smartphone
• Severe cognitive impairments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role: collaborator

Obra Social de La Caixa

UNKNOWN

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: lead

Responsible Party

Jordi Miró

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chair in Pediatric Pain - Universitat Rovira i Virgili

Tarragona, , Spain

Countries

Spain

Related Links

http://algos-dpsico.urv.cat/en/

Research group webpage

Other Identifiers

PSI2012-32471

Identifier Type: -

Identifier Source: org_study_id