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出境医 / 临床实验 / Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia (DOLORTRATPSI)

Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia (DOLORTRATPSI)

Study Description
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:

  1. To study the sociodemographic and clinical profile of patients with chronic pain, with and without fibromyalgia.
  2. Define the characteristics of patients who are in the different stages of the disease: stage 1 (less than two years since diagnosis); stage 2 (between 2 and 4 years); stage 3 (between 5 and 8 years), and stage 4 (more than 8 years).
  3. Check the effectiveness of psychological therapies (CBT vs MBPM) depending on the presence of fibromyalgia.
  4. Check the effectiveness of the psychological treatment in function of the stage of the disease.

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

Detailed Description:
The objetive of this research are the study of differential efficacy in chronic pain and fybromyalgia with CBT or mindfulness therapy.
Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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

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

Outcome Measures
Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in the Fibromyalgia Impact Questionnaire- FIQ [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]

    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)


  2. Change in the Listado de Sintomas Breve- LSB-50 [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    it is composed of 50 items, which are rated on a Likert scale from 0 to 4, depending on the level of discomfort caused by each item to the subject. it includes two scales of validity, three general indices, clinical scales (psychoreactivity, hypersensitivity, obsession, anxiety, hostility, somatization, depression, and sleep disturbances) and a psychological risk index. (de Rivera & Abuin, 2012)

  3. Change in the Short Form 12 Health Survey- SF-12 [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]

    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)


  4. Change in Cuestionario de afrontamiento del dolor- CAD-R [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    It consists of 31 items related to the strategies that the patient performs when suffer pain. The strategies are valued from 1 (never use) to 5 (always use). The items are grouped into the following factors: religion, catharsis, distraction, information search, self-control, and self-affirmation. (Soriano & Monsaslve, 2002)

  5. Change in Connor-Davison Resilience Scale- CDRISC [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    The CD-RISC scale assesses resilience. Consist in 25 items and the subject has to indicate what extent each of the statements has been true, in his case, during the last month on a scale ranging from 0 (not true at all) to 4 (almost always true). Fernández-Lansac & Soberón, 2014)

  6. Change in Inventaire of negative thoughts in response to pain- INTRP [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    This questionnaire assesses the presence of negative thinking in response to pain. It consists of 21 items distributed in 5 factors: general negative thoughts, negative social thoughts, thoughts of disability, thoughts of lack of control, and thoughts of self-blame (Cano & Rodriguez, 2002)

  7. Change Pain Catastrophizing Scale- PCS [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    The scale evaluates through 13 items the thoughts and feelings related to the experiences of pain. It is divided into three subscales, scored from 0 (never) to 4 (always), rumination, desperation, and magnification (Lami et al., 2013)

  8. Change in Chronic Pain Acceptance Questionnaire- CPAQ [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    The scale evaluates strategies of the pain experience. It consists of 20 items, scored from 0 (never true) to 6 (always true), from which three scores are obtained: involvement in activities, openness to pain, and total punctuation.


Other Outcome Measures:
  1. 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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be able to complete the assessment protocol
  • Suffer from chronic non-oncological pain, lasting longer than 6 months
  • Not being receiving psychological treatment
  • Sign the informed consent

Exclusion Criteria:

  • Present a cognitive impairment, such as a dementia
  • Present a diagnosis of a psychotic disease, bipolar disease or additive disease
Contacts and Locations

Locations
Layout table for location information
Spain
University of Basque Country
San Sebastián, Guipuzcoa, Spain, 20018
Sponsors and Collaborators
Basque Country University
Investigators
Layout table for investigator information
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
 (submitted: June 19, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Change in the Fibromyalgia Impact Questionnaire- FIQ [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    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)
  • Change in the Listado de Sintomas Breve- LSB-50 [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    it is composed of 50 items, which are rated on a Likert scale from 0 to 4, depending on the level of discomfort caused by each item to the subject. it includes two scales of validity, three general indices, clinical scales (psychoreactivity, hypersensitivity, obsession, anxiety, hostility, somatization, depression, and sleep disturbances) and a psychological risk index. (de Rivera & Abuin, 2012)
  • Change in the Short Form 12 Health Survey- SF-12 [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    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)
  • Change in Cuestionario de afrontamiento del dolor- CAD-R [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    It consists of 31 items related to the strategies that the patient performs when suffer pain. The strategies are valued from 1 (never use) to 5 (always use). The items are grouped into the following factors: religion, catharsis, distraction, information search, self-control, and self-affirmation. (Soriano & Monsaslve, 2002)
  • Change in Connor-Davison Resilience Scale- CDRISC [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    The CD-RISC scale assesses resilience. Consist in 25 items and the subject has to indicate what extent each of the statements has been true, in his case, during the last month on a scale ranging from 0 (not true at all) to 4 (almost always true). Fernández-Lansac & Soberón, 2014)
  • Change in Inventaire of negative thoughts in response to pain- INTRP [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    This questionnaire assesses the presence of negative thinking in response to pain. It consists of 21 items distributed in 5 factors: general negative thoughts, negative social thoughts, thoughts of disability, thoughts of lack of control, and thoughts of self-blame (Cano & Rodriguez, 2002)
  • Change Pain Catastrophizing Scale- PCS [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    The scale evaluates through 13 items the thoughts and feelings related to the experiences of pain. It is divided into three subscales, scored from 0 (never) to 4 (always), rumination, desperation, and magnification (Lami et al., 2013)
  • Change in Chronic Pain Acceptance Questionnaire- CPAQ [ Time Frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41) ]
    The scale evaluates strategies of the pain experience. It consists of 20 items, scored from 0 (never true) to 6 (always true), from which three scores are obtained: involvement in activities, openness to pain, and total punctuation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 19, 2019)
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)
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:

  1. To study the sociodemographic and clinical profile of patients with chronic pain, with and without fibromyalgia.
  2. Define the characteristics of patients who are in the different stages of the disease: stage 1 (less than two years since diagnosis); stage 2 (between 2 and 4 years); stage 3 (between 5 and 8 years), and stage 4 (more than 8 years).
  3. Check the effectiveness of psychological therapies (CBT vs MBPM) depending on the presence of fibromyalgia.
  4. Check the effectiveness of the psychological treatment in function of the stage of the disease.

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.

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
Condition  ICMJE
  • Fibromyalgia
  • Chronic Pain
Intervention  ICMJE
  • Behavioral: CBT for chronic pain
    12 group sessions of cognitive behavioral treatment to manage pain
  • Behavioral: MBPM- Mindfulness-Based Pain Management
    8 group session of maindfulness-based treatment to management pain
Study Arms  ICMJE
  • 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

    Intervention: Behavioral: CBT for chronic pain
  • 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

    Intervention: Behavioral: MBPM- Mindfulness-Based Pain Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 19, 2019)
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:

  • Be able to complete the assessment protocol
  • Suffer from chronic non-oncological pain, lasting longer than 6 months
  • Not being receiving psychological treatment
  • Sign the informed consent

Exclusion Criteria:

  • Present a cognitive impairment, such as a dementia
  • Present a diagnosis of a psychotic disease, bipolar disease or additive disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Karmele Salaberria, PH.D University of Basque Country
PRS Account Basque Country University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP