FibromyalgiaPbRENCT04084873
An Emotional Regulation Brief Procedure (PbRE) for Fibromyalgia Using ICT's
A study testing PBrE in people with Fibromyalgia and Chronic Pain, run by Universidad Nacional de Educación a Distancia at 1 site in Spain.
Trial summary
The study aims is to test the efficacy of an emotional regulation procedure for fibromyalgia patients using Information and Communications Technologies (ICTs). This procedure is based in a task that implies exposition to emotional words. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- PBrE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 7 Oct 2019to Oct 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
- Met the American College of Rheumatology (ACR) 2010 research classification criteria for FM (Wolfe et al., 2010, 2011); as confirmed by a rheumatologist
- A minimum of 18 years of age
- Showed adequate reading comprehension
- Were able to use a smartphone
- Were able to sign an informed consent form.
Who cannot join
- Had any mental disorder treated by a psychiatrist
- Were scheduled for surgery in the next 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotional Regulation Brief Procedure for Fibromyalgia, Through the Internet
The study aims is to test the efficacy of an emotional regulation procedure for fibromyalgia patients using Information and Communications Technologies (ICTs). This procedure is based in a task that implies exposition to emotional words. The principal hypothesis is that exposition will improve the clinical symptomatology because the procedure restore an adequate emotional regulation.
Read the detailed description
Previous studies have demonstrated that FM patients have difficulties to process emotional words when they are compared to normal subjects (Mercado et al., 2013). This dysfunctional emotion regulation could show attentional bias and it could be a way to increase FM symptomatology as pain, and fatigue (Duscheck et al., 2014).
The emotion generation and its regulation through an experimental task as reading words is a well stablished procedure (Lang, Bradley y Cuthbert, 1997). This paradigm has been shown efficacy in clinical context, to reduce anxiety in social phobia (Masia et al., 1999; Baños, Quero y Botella, 2008), generalized anxiety disorders (Fracalanza, Kroner y Antony, 2014), personality disorders (Arntz et al., 2012), and depression (Chuang et al., 2016). To address the gap between the experimental results of this form of emotional regulation in FM patients, and its clinical application, the aim of this study is to evaluate the efficacy of a Brief Procedure of Emotional Regulation for Fibromyalgia (PbRE)
PbRE is a word reading task implementing through an App developed for smartphones. The patient will choose emotional positive and negative words related to personal and clinical characteristics. This exercise has been shown useful in analogous tasks in relational frame theory (Hussey y Barnes-Holmes (2012) or in bias computer training (Salemink et al., 2014).
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- PBrE, PBrE-Control, Control
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBrEBehavioural
PbRE is a word reading task implementing through an App developed for smartphones. The patient will choose emotional positive and negative words related to personal and clinical characteristics.
PBrE-ControlBehavioural
Participants are exposed to several neutral words. These words do not have any emotional content and there are no reasons to think that they have any effect over the emotional regulation.
ControlBehavioural
Participants do not receive the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental PBrE | Experimental | Participants are exposed to several words of emotional contents (positive, and negative). The differences between these words will allow the regulation and counter regulation of emotional processes (Schwager y Rothermund, 2013). The words are related to clinical and personal characteristics of the patients and they will promote an emotional identification that improve the emotional regulation (Kashdan, Barret y McKnight, 2015). Receives: Behavioral: PBrE |
| Control PBrE | Placebo comparator | Participants are exposed to several neutral words. These words do not have any emotional content and there are no reasons to think that they have any effect over the emotional regulation. Receives: Behavioral: PBrE-Control |
| Control | Other | Participants do not receive the intervention. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed
The Combined Index of Severity in Fibromyalgia (ICAF) is a questionnaire that allows the classification of patients by severity in clinical practice. This analysis is a self-report questionnaire of 59 items constructed with the most common clinical manifestations of FM (Vallejo, Rivera, \& Esteve-Vives, 2010). The ICAF questionnaire offers total scores, where higher scores indicate a more severe disease. This questionnaire also provides four factors: emotional, physical (pain, fatigue, sleep quality and functional capacity), active coping, and passive coping. Similar to the total score, higher scores on each factor indicate greater severity, with the exception of the active coping factor, where higher scores indicate a better way to cope with the disease.
Measured: Through study completion, an average of 1 year
Fibromyalgia Impact Questionnaire (FIQ). Change is being assessed
The Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt, Clark, \& Bennett, 1991; Rivera \& González, 2004) is a self-report questionnaire designed to evaluate the impact of the FM on the life of the patient. This 10-item questionnaire is widely used and covers the principal areas of interest, including physical functioning, pain, sleep, mental health, and fatigue. The score ranges from 0 to 100, where higher scores indicate a more severe impact of the disease.
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
EuroQol-5D-5L
The EuroQol-5D-L questionnaire (Herdman et al., 2011) is divided into 2 sections. The first section contains 5 questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Five levels for answering are included (no problems, slight problems, moderate problems, severe problems and extreme problems), ranging from 1 to 5. The second part is a VAS score, which records the responder's self-evaluated health, where 0 is worst imaginable health and 100 is best imaginable health.
Measured: Through treatment completion, an average of 6 weeks
Credibility and Expectancy Questionnaire (CEQ)
Patients' expectancy of treatment will be assessed with the Credibility and Expectancy Questionnaire (CEQ) (Devilly and Borkovec, 2010). Both factors (credibility and expectancy) have been shown to be stable across different populations with high internal consistency within each factor. The scale consists of six questions, with answer options rated on a 10-point scale and on a 1-100 % scale.
Measured: Through treatment completion, an average of 6 weeks
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire, in its 8-item version (CSQ-8; Larsen et al. 1979), has been used most commonly to assess satisfaction in mental health services. This tool includes a brief standardized scale with good psychometric properties that provides an overall assessment of satisfaction. We used the Spanish version of the CSQ-8 (Vázquez et al., 2017).
Measured: Through treatment completion, an average of 6 weeks
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) (Sullivan, Bishop, \& Pivik, 1995) is a 13-item scale used to assess pain catastrophizing. Participants rated the frequency of 13 negative pain-related thoughts and feelings on a 5-point Likert scale from 0 (not at all) to 4 (all the time). The range of scores is 0 to 54. Higher scores indicate greater catastrophizing. We used the Spanish version of the PCS (García Campayo et al., 2008).
Measured: Through study completion, an average of 1 year
Acceptance and Action Questionnaire - II
Acceptance and Action Questionnaire - II (Bond et al., 2011; Ruiz, et al., 2013). The AAQ-II is a general measure of experiential avoidance and psychological inflexibility. It consists of 7 items which are responded to by using a 7-point Likert scale. The items reflect an unwillingness to experience unwanted emotions and thoughts.
Measured: Through study completion, an average of 1 year
Short Form 12 Health Survey
The Short Form 12 Health Survey (SF-12) (Vilagut et al., 2008; Ware \& Keller, 1996) is a generic instrument used to assess health-related quality of life. It is a self-report survey of 12 items grouped into eight dimensions: physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role and mental health. The score ranges from 0 to 100 for every scale, where higher scores indicate better health.
Measured: Through study completion, an average of 1 year
Emotion Regulation Questionnaire
The Emotion Regulation Questionnaire (Gross \& John, 2003; Cabello, Salgero, Fernández-Berrocal \& Gross, 2013) consist of 10 items which are responded to by using a 7-point Likert scale. The items are grouped into two dimensions: cognitive reappraisal and expressive suppression.
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 posted10 Sep 2019
- Study start7 Oct 2019
- Primary completionMay 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Educación a Distancia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084873
- Sponsor's protocol ID
- iTCC55
- Acronym
- PbRE
- Status last verified
- Nov 2020
- First submitted
- 4 Sep 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arntz A, Hawke LD, Bamelis L, Spinhoven P, Molendijk ML. Changes in natural language use as an indicator of psychotherapeutic change in personality disorders. Behav Res Ther. 2012 Mar;50(3):191-202. doi: 10.1016/j.brat.2011.12.007. Epub 2012 Jan 4.
PubMed 22317755Bennett MP, Meulders A, Baeyens F, Vlaeyen JW. Words putting pain in motion: the generalization of pain-related fear within an artificial stimulus category. Front Psychol. 2015 Apr 30;6:520. doi: 10.3389/fpsyg.2015.00520. eCollection 2015.
PubMed 25983704Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21.
PubMed 24447855Mercado F, Gonzalez JL, Barjola P, Fernandez-Sanchez M, Lopez-Lopez A, Alonso M, Gomez-Esquer F. Brain correlates of cognitive inhibition in fibromyalgia: emotional intrusion of symptom-related words. Int J Psychophysiol. 2013 May;88(2):182-92. doi: 10.1016/j.ijpsycho.2013.03.017. Epub 2013 Apr 2.
PubMed 23557844Montoya P, Sitges C, Garcia-Herrera M, Izquierdo R, Truyols M, Blay N, Collado D. Abnormal affective modulation of somatosensory brain processing among patients with fibromyalgia. Psychosom Med. 2005 Nov-Dec;67(6):957-63. doi: 10.1097/01.psy.0000188401.55394.18.
PubMed 16314601Schwager S, Rothermund K. Counter-regulation triggered by emotions: positive/negative affective states elicit opposite valence biases in affective processing. Cogn Emot. 2013;27(5):839-55. doi: 10.1080/02699931.2012.750599. Epub 2012 Dec 14.
PubMed 23237331
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Regulation Brief Procedure for Fibromyalgia, Through the Internet
- ClinicalTrials.gov ID
- NCT04084873
- Acronym / sponsor ID
- PbRE / iTCC55
- Conditions
- Fibromyalgia, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Nacional de Educación a DistanciaUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Sep 2019 (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.
The study aims is to test the efficacy of an emotional regulation procedure for fibromyalgia patients using Information and Communications Technologies (ICTs). This procedure is based in a task that implies exposition to emotional words. The principal hypothesis is that exposition will improve the clinical symptomatology because the procedure restore an adequate emotional regulation.
Detailed description
Previous studies have demonstrated that FM patients have difficulties to process emotional words when they are compared to normal subjects (Mercado et al., 2013). This dysfunctional emotion regulation could show attentional bias and it could be a way to increase FM symptomatology as pain, and fatigue (Duscheck et al., 2014).
The emotion generation and its regulation through an experimental task as reading words is a well stablished procedure (Lang, Bradley y Cuthbert, 1997). This paradigm has been shown efficacy in clinical context, to reduce anxiety in social phobia (Masia et al., 1999; Baños, Quero y Botella, 2008), generalized anxiety disorders (Fracalanza, Kroner y Antony, 2014), personality disorders (Arntz et al., 2012), and depression (Chuang et al., 2016). To address the gap between the experimental results of this form of emotional regulation in FM patients, and its clinical application, the aim of this study is to evaluate the efficacy of a Brief Procedure of Emotional Regulation for Fibromyalgia (PbRE)
PbRE is a word reading task implementing through an App developed for smartphones. The patient will choose emotional positive and negative words related to personal and clinical characteristics. This exercise has been shown useful in analogous tasks in relational frame theory (Hussey y Barnes-Holmes (2012) or in bias computer training (Salemink et al., 2014).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental PBrE | Experimental | Behavioral: PBrEParticipants are exposed to several words of emotional contents (positive, and negative). The differences between these words will allow the regulation and counter regulation of emotional processes (Schwager y Rothermund, 2013). The words are related to clinical and personal characteristics of the patients and they will promote an emotional identification that improve the emotional regulation (Kashdan, Barret y McKnight, 2015). |
| Control PBrE | Placebo comparator | Behavioral: PBrE-ControlParticipants are exposed to several neutral words. These words do not have any emotional content and there are no reasons to think that they have any effect over the emotional regulation. |
| Control | Other | Behavioral: ControlParticipants do not receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Met the American College of Rheumatology (ACR) 2010 research classification criteria for FM (Wolfe et al., 2010, 2011); as confirmed by a rheumatologist
- A minimum of 18 years of age
- Showed adequate reading comprehension
- Were able to use a smartphone
- Were able to sign an informed consent form.
Key exclusion criteria (2 listed)
- Had any mental disorder treated by a psychiatrist
- Were scheduled for surgery in the next 3 months.
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 |
|---|---|---|
| PBrEPbRE is a word reading task implementing through an App developed for smartphones. The patient will choose emotional positive and negative words related to personal and clinical characteristics. | Behavioural | Experimental PBrE |
| PBrE-ControlParticipants are exposed to several neutral words. These words do not have any emotional content and there are no reasons to think that they have any effect over the emotional regulation. | Behavioural | Control PBrE |
| ControlParticipants do not receive the intervention. | Behavioural | Control |
Primary outcome
Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed
Time frame: Through study completion, an average of 1 year
The Combined Index of Severity in Fibromyalgia (ICAF) is a questionnaire that allows the classification of patients by severity in clinical practice. This analysis is a self-report questionnaire of 59 items constructed with the most common clinical manifestations of FM (Vallejo, Rivera, \& Esteve-Vives, 2010). The ICAF questionnaire offers total scores, where higher scores indicate a more severe disease. This questionnaire also provides four factors: emotional, physical (pain, fatigue, sleep quality and functional capacity), active coping, and passive coping. Similar to the total score, higher scores on each factor indicate greater severity, with the exception of the active coping factor, where higher scores indicate a better way to cope with the disease.
Fibromyalgia Impact Questionnaire (FIQ). Change is being assessed
Time frame: Through study completion, an average of 1 year
The Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt, Clark, \& Bennett, 1991; Rivera \& González, 2004) is a self-report questionnaire designed to evaluate the impact of the FM on the life of the patient. This 10-item questionnaire is widely used and covers the principal areas of interest, including physical functioning, pain, sleep, mental health, and fatigue. The score ranges from 0 to 100, where higher scores indicate a more severe impact of the disease.
7 secondary outcomes
EuroQol-5D-5L
Time frame: Through treatment completion, an average of 6 weeks
Credibility and Expectancy Questionnaire (CEQ)
Time frame: Through treatment completion, an average of 6 weeks
Client Satisfaction Questionnaire
Time frame: Through treatment completion, an average of 6 weeks
Pain Catastrophizing Scale (PCS)
Time frame: Through study completion, an average of 1 year
Acceptance and Action Questionnaire - II
Time frame: Through study completion, an average of 1 year
Short Form 12 Health Survey
Time frame: Through study completion, an average of 1 year
Emotion Regulation Questionnaire
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 22317755Arntz A, Hawke LD, Bamelis L, Spinhoven P, Molendijk ML. Changes in natural language use as an indicator of psychotherapeutic change in personality disorders. Behav Res Ther. 2012 Mar;50(3):191-202. doi: 10.1016/j.brat.2011.12.007. Epub 2012 Jan 4.
- Background: PubMed 25983704Bennett MP, Meulders A, Baeyens F, Vlaeyen JW. Words putting pain in motion: the generalization of pain-related fear within an artificial stimulus category. Front Psychol. 2015 Apr 30;6:520. doi: 10.3389/fpsyg.2015.00520. eCollection 2015.
- Background: PubMed 24447855Duschek S, Werner NS, Limbert N, Winkelmann A, Montoya P. Attentional bias toward negative information in patients with fibromyalgia syndrome. Pain Med. 2014 Apr;15(4):603-12. doi: 10.1111/pme.12360. Epub 2014 Jan 21.
- Background: PubMed 23557844Mercado F, Gonzalez JL, Barjola P, Fernandez-Sanchez M, Lopez-Lopez A, Alonso M, Gomez-Esquer F. Brain correlates of cognitive inhibition in fibromyalgia: emotional intrusion of symptom-related words. Int J Psychophysiol. 2013 May;88(2):182-92. doi: 10.1016/j.ijpsycho.2013.03.017. Epub 2013 Apr 2.
- Background: PubMed 16314601Montoya P, Sitges C, Garcia-Herrera M, Izquierdo R, Truyols M, Blay N, Collado D. Abnormal affective modulation of somatosensory brain processing among patients with fibromyalgia. Psychosom Med. 2005 Nov-Dec;67(6):957-63. doi: 10.1097/01.psy.0000188401.55394.18.
- Background: PubMed 23237331Schwager S, Rothermund K. Counter-regulation triggered by emotions: positive/negative affective states elicit opposite valence biases in affective processing. Cogn Emot. 2013;27(5):839-55. doi: 10.1080/02699931.2012.750599. Epub 2012 Dec 14.
- 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 PBrE in people with Fibromyalgia and Chronic Pain, run by Universidad Nacional de Educación a Distancia 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 5 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 6 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
Combined Index of Severity in Fibromyalgia (ICAF). Change is being assessed (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084873, which also lists 6 linked publications.
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 6 Nov 2020.