Today, one of the most important challenges of the health system is the attitude towards chronic disorders. That implies changing from a health structure established for the treatment of acute diseases to a continued care system.
In this sense, the approach of chronic pain, of non-oncological origin, supposes an important care challenge, to which this project wishes to respond.
Chronic pain affects one of every Europeans (19%), and has a prevalence of 11% in Spain, being one of the most important causes of medical consultation and is associated with high personal, social and economic costs. For example, in 2017 it was calculated that it has an economic impact of between 1.7 and 2.1% of Spain's GDP.
Referred to the psychological consequences of the disease, it has been found that 42% of people who have chronic pain suffer insomnia, a 40% anxiety, and 24% depressive symptoms. Hence the importance of implementing evidence-based psychological treatments along with their treatment as usual The main objective is comparing the efficacy of two treatments, cognitive-behavioral therapy (CBT) and mindfulness-based pain management (MBPM), together with the usual medical treatment, in patients diagnosed with chronic pain, with and without comorbid fibromyalgia.
Specific objectives are:
Method:
A quasi-experimental design of three groups will be used. Patients will be assigned to any of the experimental groups: Group 1 (40 subjects) will receive CBT. Group 2 (40 subjects) will receive MBPM. Finally, group 3 (40 subjects) 3-months wait list, after which time they will also receive MBPM.
All the participants will be assessed in the baseline; at the end of the treatment; and in the 1, 3, 6 and 12 months follow-ups. Group 3 (waiting list) will be assessed in the baseline, and re-assessed before starting the treatment; at the end of the psychological therapy; and in the 1, 3, 6 and 12 months follow-ups.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia Chronic Pain | Behavioral: CBT for chronic pain Behavioral: MBPM- Mindfulness-Based Pain Management | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Differential Efficacy of Cognitive Behavioral Therapy Versus Mindfulness-based Pain Management in Patients With Chronic Pain With and Without Fibromyalgia |
| Actual Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | November 30, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: CBT for chronic pain
Cognitive-behavioral treatment with twelve group sessions (6-8 subjects) with a duration of between 90 and 120 minutes and a weekly periodicity (total hours1080). components of the intervention are: reducing pain and emotional discomfort, increasing adaptive behaviors, changing irrational thoughts associated with pain, increasing self-efficacy, reducing anxiety, decreasing catastrophic thoughts and increasing healthy habits |
Behavioral: CBT for chronic pain
12 group sessions of cognitive behavioral treatment to manage pain
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Experimental: MBPM- Minfulness- Based Pain Management
Psychological intervention with 8 group sessions ( 8 -10 subjects) with a duration of 2 and a half hours per session and a weekly periodicity (total hours 1080). It is centered on training on the awareness of physical, cognitive and emotional sensations, and the attentional processes to become an observer of one's own thoughts and emotions. With the aim to provide greater flexibility to manage pain |
Behavioral: MBPM- Mindfulness-Based Pain Management
8 group session of maindfulness-based treatment to management pain
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its a 10 item scale that assesses the impact of the disease. The first item evaluates the interference of the disease in skills such as home care and work. The second item assesses how they felt last week; the third item values the days of last week that the disease prevented him from performing his usual tasks. Finally, the fourth item assesses the interference caused by pain and other items of the disease.
It will only be completed by patients diagnosed with fibromyalgia. (Esteve et al., 2007)
It assesses a patient's health perception in 12 areas like physical function, physical role, body pain, general health, vitality, social function, emotional role, and mental health.
It is completed with Likert type response options from 3 to 5 points.(Schmidt et al., 2012)
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Spain | |
| University of Basque Country | |
| San Sebastián, Guipuzcoa, Spain, 20018 | |
| Principal Investigator: | Karmele Salaberria, PH.D | University of Basque Country |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 14, 2019 | ||||
| First Posted Date ICMJE | June 20, 2019 | ||||
| Last Update Posted Date | January 28, 2021 | ||||
| Actual Study Start Date ICMJE | June 1, 2019 | ||||
| Estimated Primary Completion Date | November 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Lattinen Index- IL [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ] It is a scale with five items to assess variables associated with pain: frequency, intensity, disability, drugs usage and sleep problems. These are assessed by a Likert scale of 0 to 4, in order to explain the discomfort that pain generates. (Gonzalez-Escada, 2012)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
Client Satisfaction Questionnaire [ Time Frame: end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ] This scale assesses clients satisfaction with the treatment through 8 items, using a Likert scale from 0 to 4. (Larsen et al., 1978)
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia | ||||
| Official Title ICMJE | Differential Efficacy of Cognitive Behavioral Therapy Versus Mindfulness-based Pain Management in Patients With Chronic Pain With and Without Fibromyalgia | ||||
| Brief Summary |
Today, one of the most important challenges of the health system is the attitude towards chronic disorders. That implies changing from a health structure established for the treatment of acute diseases to a continued care system. In this sense, the approach of chronic pain, of non-oncological origin, supposes an important care challenge, to which this project wishes to respond. Chronic pain affects one of every Europeans (19%), and has a prevalence of 11% in Spain, being one of the most important causes of medical consultation and is associated with high personal, social and economic costs. For example, in 2017 it was calculated that it has an economic impact of between 1.7 and 2.1% of Spain's GDP. Referred to the psychological consequences of the disease, it has been found that 42% of people who have chronic pain suffer insomnia, a 40% anxiety, and 24% depressive symptoms. Hence the importance of implementing evidence-based psychological treatments along with their treatment as usual The main objective is comparing the efficacy of two treatments, cognitive-behavioral therapy (CBT) and mindfulness-based pain management (MBPM), together with the usual medical treatment, in patients diagnosed with chronic pain, with and without comorbid fibromyalgia. Specific objectives are:
Method: A quasi-experimental design of three groups will be used. Patients will be assigned to any of the experimental groups: Group 1 (40 subjects) will receive CBT. Group 2 (40 subjects) will receive MBPM. Finally, group 3 (40 subjects) 3-months wait list, after which time they will also receive MBPM. All the participants will be assessed in the baseline; at the end of the treatment; and in the 1, 3, 6 and 12 months follow-ups. Group 3 (waiting list) will be assessed in the baseline, and re-assessed before starting the treatment; at the end of the psychological therapy; and in the 1, 3, 6 and 12 months follow-ups. |
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| Detailed Description | The objetive of this research are the study of differential efficacy in chronic pain and fybromyalgia with CBT or mindfulness therapy. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Actual Enrollment ICMJE |
120 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
| Estimated Primary Completion Date | November 30, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03992612 | ||||
| Other Study ID Numbers ICMJE | PI2018162 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Karmele Salaberria, Basque Country University | ||||
| Study Sponsor ICMJE | Basque Country University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Basque Country University | ||||
| Verification Date | June 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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