Chronic Widespread Pain

NCT04942132 | Unknown

• 1 other identifier: PSI2012-32471
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic Pain; Mobile Health; Adolescents; Young adults; Fibromyalgia; Chronic Widespread Pain

Outcome Measures

Primary Outcomes (5)

• Average Pain Intensity

  Participants are asked to report three domains of pain intensity (i.e., average, worst, and current) using 0-10 numerical rating scales (NRS-11) with 0 meaning "No pain" and 10 meaning "Very much pain". A composite score (consisting of the mean of the individuals' three pain intensity scores) will be used as a measure of pain intensity.

  through study completion, an average of 1 year

• Sleep Quality

  Questionnaire used: Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality over the past month. The responder is requested to answer 19 questions that assess a variety of factors related to sleep quality. These 19 items generate seven component scores (each weighted equally on a 0-3 scale): sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication and daytime dysfunction. The seven component scores are summed into a global PSQI score, which has a range of 0-21; higher score indicates worse sleep quality. This questionnaire includes five questions for the roommate of the responder which are used for clinical information and will not be included in this study.

  through study completion, an average of 1 year

• Anxiety

  Questionnaire used: The Spanish version of Patient-Reported Outcomes Measurement the Information System short form for Anxiety (PROMIS Short Form v1.0 - Anxiety 8a). It has 8 items asking about the frequency of physiological arousal, somatic symptoms and concerns in the past week. Participants will be asked to rate the frequency with which they experienced 8 anxiety symptoms in the last 7 days using a 5-point Likert scale (1= "Never"; 2 = "Almost never"; 3 = "Sometimes"; 4 = "Often"; 5 = "Almost always"). PROMIS-Anxiety has shown to provide a reliable measure of anxiety symptoms with ethnically diverse groups

  through study completion, an average of 1 year

• Depression

  Questionnaire used: The Spanish version of the PROMIS short form for Depression (PROMIS Short Form v1.0 - Depression 8a). This scale consists of 8 items that assesses the frequency of affective and cognitive manifestations of depression in the past week. The PROMIS Short Form v1.0 has been shown to provide a reliable measure of depressive symptoms when used with women with fibromyalgia

  through study completion, an average of 1 year

• Fatigue

  Questionnaire used: the Silhouettes Fatigue Scale (SFS) The SFS is a visual scale that has six human silhouettes showing an increasing level of fatigue from left to right, from "no fatigue" to "a lot of fatigue". SFS has shown to provide valid and reliable information when used with adults.

  through study completion, an average of 1 year

Study Arms (1)

Treatment

EXPERIMENTAL

A Smartphone self-administered cognitive-behavioral based intervention

Behavioral: Cognitive-behavioral (CBT)

Interventions

Cognitive-behavioral (CBT) 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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Ministerio de Economía y Competitividad, Spain: collaborator
• Obra Social de La Caixa: collaborator

Study Sites (1)

Chair in Pediatric Pain - Universitat Rovira i Virgili

Tarragona, 43007, Spain

Location

Related Links

• Research group webpage

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: June 28, 2021
• Study Start: January 22, 2019
• Primary Completion: June 15, 2021
• Study Completion: September 30, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)