Chronic PainFIBROLINENCT04942132
Chronic Widespread Pain
A study testing Cognitive-behavioral (CBT) in people with Chronic Pain, run by University Rovira i Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Cognitive-behavioral (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia or chronic widespread pain
- Capable of understanding, reading and writing in Spanish
Who cannot join
- Physical disabilities that interfered in the use of a Smartphone
- Severe cognitive impairments
Trial locations and contacts
1 site in 1 country.
Spain1 site
Chair in Pediatric Pain - Universitat Rovira i Virgili
Tarragona, 43007
About this study
Official title: Managing Chronic Widespread Pain With FIBROLINE
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.
Read the 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
- Being tested
- Cognitive-behavioral (CBT)
- Keywords
- Chronic Pain, Mobile Health, Adolescents, Young adults, Fibromyalgia, Chronic Widespread Pain
- Medical subject headings
- Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral (CBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | A Smartphone self-administered cognitive-behavioral based intervention Receives: Behavioral: Cognitive-behavioral (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start22 Jan 2019
- Primary completion15 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, La Caixa Foundation
- Responsible party
- Principal investigator, Jordi Miró, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942132
- Sponsor's protocol ID
- PSI2012-32471
- Acronym
- FIBROLINE
- Status last verified
- Jun 2021
- First submitted
- 11 Jan 2017
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Chronic Widespread Pain With FIBROLINE
- ClinicalTrials.gov ID
- NCT04942132
- Acronym / sponsor ID
- FIBROLINE / PSI2012-32471
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Mobile Health, Adolescents, Young adults, Fibromyalgia, Chronic Widespread Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, La Caixa Foundation
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Cognitive-behavioral (CBT)A Smartphone self-administered cognitive-behavioral based intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of fibromyalgia or chronic widespread pain
- Capable of understanding, reading and writing in Spanish
Key exclusion criteria (2 listed)
- Physical disabilities that interfered in the use of a Smartphone
- Severe cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Treatment |
Primary outcome
Average Pain Intensity
Time frame: through study completion, an average of 1 year
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.
Sleep Quality
Time frame: through study completion, an average of 1 year
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.
Anxiety
Time frame: through study completion, an average of 1 year
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
Depression
Time frame: through study completion, an average of 1 year
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
Fatigue
Time frame: through study completion, an average of 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Research group webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral (CBT) in people with Chronic Pain, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Intensity (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.