CatastrophizationNO+PAINNCT04509154
Effectiveness of the Multicomponent Therapy in Chronic Pain Through The Use of Smartphones
A study testing Multimodal pain therapy and Standardized treatment. in people with Catastrophization and Chronic Pain, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Catastrophization, Chronic Pain, Pain, Chronic
- What is being tested?
- Multimodal pain therapy and Standardized treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2017to 30 Mar 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effectiveness of Cognitive Behavioral Therapy Against Chronic Pain From a Gender Perspective Through Information Technology in the Southern Health Area of Córdoba
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. .
Read more
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.
Read the 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.
- Conditions
- Catastrophization, Chronic Pain, Pain, Chronic, Cognitive Therapy, Smartphones, Acceptance, Social
- Being tested
- Multimodal pain therapy, Standardized treatment.
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal pain therapyOther
Also called NO+PAIN ,SMARPHONE
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.
Standardized treatment.Other
Also called FACE-TO-FACE
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal pain therapy | Experimental | 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. Receives: Other: Multimodal pain therapy |
| Standardized treatment. | Experimental | 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. Receives: Other: Standardized treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 MONTH
Secondary outcomes (1)
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). .
Measured: 6 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start30 Oct 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for CatastrophizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolanda Morcillo, Maimónides Biomedical Research Institute of Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509154
- Sponsor's protocol ID
- IMIBIC PI-0447-2017
- Other IDs
- PI-0447-2017
- Acronym
- NO+PAIN
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.
PubMed 21565446Deckert S, Kaiser U, Kopkow C, Trautmann F, Sabatowski R, Schmitt J. A systematic review of the outcomes reported in multimodal pain therapy for chronic pain. Eur J Pain. 2016 Jan;20(1):51-63. doi: 10.1002/ejp.721. Epub 2015 May 29.
PubMed 26031689Finset, A., Butow, P., Zimmermann Peter Salmon Peter Schulz, C., Steele Europe Robert Hulsman, D., Hatem, D., Rider Europe Shmuel Reis, E., … Florence van Zuuren, K. (n.d.). Official Journal of The European Association for Communication in Healthcare The American Academy on Communication in Healthcare EDITOR-IN-CHIEF Medical Education Editors Americas Reflective Practice Editors Americas. Retrieved from http://www.elsevier.com/
Garcia-Palacios A, Herrero R, Belmonte MA, Castilla D, Guixeres J, Molinari G, Banos RM. Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study. Eur J Pain. 2014 Jul;18(6):862-72. doi: 10.1002/j.1532-2149.2013.00425.x. Epub 2013 Nov 22.
PubMed 24921074Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. part 2: 11-month follow-up results of a randomized trial. J Med Internet Res. 2013 Mar 28;15(3):e72. doi: 10.2196/jmir.2442.
PubMed 23538392Kristjansdottir OB, Fors EA, Eide E, Finset A, van Dulmen S, Wigers SH, Eide H. Written online situational feedback via mobile phone to support self-management of chronic widespread pain: a usability study of a Web-based intervention. BMC Musculoskelet Disord. 2011 Feb 25;12:51. doi: 10.1186/1471-2474-12-51.
PubMed 21352516Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.
PubMed 20650691Martinez-Calderon J, Jensen MP, Morales-Asencio JM, Luque-Suarez A. Pain Catastrophizing and Function In Individuals With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Mar;35(3):279-293. doi: 10.1097/AJP.0000000000000676.
PubMed 30664551SIGN 136 • Management of chronic pain. (2013). Retrieved from www.sign.ac.uk/pdf/sign50eqia.pdf. Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and Validation. In Psychological Assessment (Vol. 7).
Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.
PubMed 26818413Wildevuur SE, Simonse LW. Information and communication technology-enabled person-centered care for the "big five" chronic conditions: scoping review. J Med Internet Res. 2015 Mar 27;17(3):e77. doi: 10.2196/jmir.3687.
PubMed 25831199Yadavaia JE, Hayes SC, Vilardaga R. Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial. J Contextual Behav Sci. 2014 Oct 1;3(4):248-257. doi: 10.1016/j.jcbs.2014.09.002.
PubMed 25506545Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and Validation. In Psychological Assessment (Vol. 7).
Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
PubMed 19007576Balluerka, N., Gorostiaga, A., Alonso-Arbiol, I., & Haranburu, M. (2007). Animal Assisted Therapy View project ANOTHE View project. Retrieved from www.psicothema.com
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Cognitive Behavioral Therapy Against Chronic Pain From a Gender Perspective Through Information Technology in the Southern Health Area of Córdoba
- ClinicalTrials.gov ID
- NCT04509154
- Acronym / sponsor ID
- NO+PAIN / IMIBIC PI-0447-2017
- Conditions
- Catastrophization, Chronic Pain, Pain, Chronic, Cognitive Therapy, Smartphones, Acceptance, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 11 Aug 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multimodal pain therapy | Experimental | Other: Multimodal pain therapyThe 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. |
| Standardized treatment. | Experimental | Other: Standardized treatment.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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Multimodal pain therapyAlso: NO+PAIN ,SMARPHONEFor 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. | Other | Multimodal pain therapy |
| Standardized treatment.Also: FACE-TO-FACEFace-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. | Other | Standardized treatment. |
Primary outcome
The Pain Catastrophization Scale (PCS) (Sullivan, Bishop and Pivik, 1995), Spanish adaptation of (J. García Campayo et al., 2008),
Time frame: 6 MONTH
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).
1 secondary outcome
The Pain Acceptance Questionnaire (CPAQ) (McCracken, Vowles, & Eccleston, 2004). Spanish adaptation by (Balluerka, Gorostiaga, Alonso-Arbiol, & Haranburu, 2007)
Time frame: 6 MONTH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Results publication: PubMed 21565446Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.
- Results publication: PubMed 26031689Deckert S, Kaiser U, Kopkow C, Trautmann F, Sabatowski R, Schmitt J. A systematic review of the outcomes reported in multimodal pain therapy for chronic pain. Eur J Pain. 2016 Jan;20(1):51-63. doi: 10.1002/ejp.721. Epub 2015 May 29.
- Results publicationFinset, A., Butow, P., Zimmermann Peter Salmon Peter Schulz, C., Steele Europe Robert Hulsman, D., Hatem, D., Rider Europe Shmuel Reis, E., … Florence van Zuuren, K. (n.d.). Official Journal of The European Association for Communication in Healthcare The American Academy on Communication in Healthcare EDITOR-IN-CHIEF Medical Education Editors Americas Reflective Practice Editors Americas. Retrieved from http://www.elsevier.com/
- Results publication: PubMed 24921074Garcia-Palacios A, Herrero R, Belmonte MA, Castilla D, Guixeres J, Molinari G, Banos RM. Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study. Eur J Pain. 2014 Jul;18(6):862-72. doi: 10.1002/j.1532-2149.2013.00425.x. Epub 2013 Nov 22.
- Results publication: PubMed 23538392Kristjansdottir OB, Fors EA, Eide E, Finset A, Stensrud TL, van Dulmen S, Wigers SH, Eide H. A smartphone-based intervention with diaries and therapist feedback to reduce catastrophizing and increase functioning in women with chronic widespread pain. part 2: 11-month follow-up results of a randomized trial. J Med Internet Res. 2013 Mar 28;15(3):e72. doi: 10.2196/jmir.2442.
- Results publication: PubMed 21352516Kristjansdottir OB, Fors EA, Eide E, Finset A, van Dulmen S, Wigers SH, Eide H. Written online situational feedback via mobile phone to support self-management of chronic widespread pain: a usability study of a Web-based intervention. BMC Musculoskelet Disord. 2011 Feb 25;12:51. doi: 10.1186/1471-2474-12-51.
- Results publication: PubMed 20650691Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.
- Results publication: PubMed 30664551Martinez-Calderon J, Jensen MP, Morales-Asencio JM, Luque-Suarez A. Pain Catastrophizing and Function In Individuals With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Mar;35(3):279-293. doi: 10.1097/AJP.0000000000000676.
- Results publicationSIGN 136 • Management of chronic pain. (2013). Retrieved from www.sign.ac.uk/pdf/sign50eqia.pdf. Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and Validation. In Psychological Assessment (Vol. 7).
- Results publication: PubMed 26818413Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KM. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5-31. doi: 10.1080/16506073.2015.1098724. Epub 2016 Jan 28.
- Results publication: PubMed 25831199Wildevuur SE, Simonse LW. Information and communication technology-enabled person-centered care for the "big five" chronic conditions: scoping review. J Med Internet Res. 2015 Mar 27;17(3):e77. doi: 10.2196/jmir.3687.
- Results publication: PubMed 25506545Yadavaia JE, Hayes SC, Vilardaga R. Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial. J Contextual Behav Sci. 2014 Oct 1;3(4):248-257. doi: 10.1016/j.jcbs.2014.09.002.
- Individual participant dataSharing planned: Undecided
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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 Multimodal pain therapy and Standardized treatment. in people with Catastrophization and Chronic Pain, run by Maimónides Biomedical Research Institute of Córdoba 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Pain Catastrophization Scale (PCS) (Sullivan, Bishop and Pivik, 1995), Spanish adaptation of (J. García Campayo et al., 2008), (time frame: 6 MONTH). 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 NCT04509154, which also lists 18 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 14 Aug 2020.