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Chronic PainNCT03386422

Mindfulness Self-Compassion Intervention Versus a Cognitive-Behavioral Intervention to Improve Self-care in Chronic Pain

A study testing MSC and CBT in people with Chronic Pain, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is associated with emotional distress (anxiety and depression), physical and social impairment and reduction of quality of life in patients who suffer from this condition. 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?
MSC and CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
1 siteSpain
Study dates
3 Feb 2017to 30 Dec 2018
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

  • Older than 18 years old.
  • Being in treatment in the Chronic Pain Unit at Hospital Universitario La Paz because of having a chronic pain of more than 3 months of duration, no matter the aetiology.
  • Capable of understanding and giving his or her written informed consent.
  • Significant levels of distress related to the pain at the beginning of treatment, assessed by clinical interview and HADS (HADS-A or HADS-D > or = 8).
  • Patients that meet criteria for Mixed Adaptive Disorder, mild to moderate Depressive Disorder or Dysthymia, assessed by clinical interview conducted by a psychiatry of the Chronic Pain Unit or Mental Health Center.

Who cannot join

  • Intelectual disability or cognitive impairment or dementia.
  • Insufficient knowledge of the language to understand and participate on the intervention program.
  • Serious mental illness in acute state at the moment of the beginning of the intervention.
  • Substance abuse in the last 6 months.
  • Autolytic ideas at the moment of the assessment.
  • Previous training in mindfulness or CBT techniques.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario La Paz.

    Madrid, 28046

Other trials in Spain

About this study

Official title: "Pilot Study to Compare the Effectiveness of a Mindfulness Self-Compassion Intervention Versus a Cognitive-Behavioural Intervention to Improve Self-care and Quality of Life in a Chronic Pain Sample"

Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is associated with emotional distress (anxiety and depression), physical and social impairment and reduction of quality of life in patients who suffer from this condition.

Self-Compassion is a useful attitude in order to regulate emotions, to be able to accept the experience that one is going through and to improve self-care in general population. Cognitive-behavioral programs (CBT) have already demonstrated that they are effective in order to reduce catastrophizing and passive coping with pain. However, effects of Mindful Self-Compassion interventions (based on mindfulness skills but not only) on chronic pain condition are still unknown.

Read more

The investigator's principal hypothesis is: MSC program will be, at least, as effective as CBT program in order to improve quality of life, self-compassion, self-care and acceptance capacity; and as effective as CBT to reduce catastrophizing, anxiety and depression in a chronic pain patients sample.

Moreover, investigators also hypothesize that MSC program will be, at least, as effective as CBT program in order to maintain the achieved benefits in a 6 months follow-up.

Investigators will conduct a Randomized Controlled Trial with two treatment arms in a chronic pain sample of patients of Hospital Universitario La Paz, Madrid.

After all recollection of data is done, investigators will conduct statistic analysis in order to accept or refuse our hypothesis.

Read the detailed description

Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is associated with emotional distress (anxiety and depression), physical and social impairment and reduction of quality of life in patients who suffer from this condition.

Recent studies have elucidated that some conditions are clearly correlated with chronic pain, and could explain emotional distress and impairment in these patients. Such conditions are: attention bias to pain, cognitive inflexibility, fear avoidance, catastrophizing, passive coping with pain and no acceptance.

Recent meta-analysis suggest that Mindfulness-based interventions reduce anxiety and pain interference in daily life in patients with chronic pain. They do so through mechanisms that improve capacity of acceptance (whatever the experience is) and reduce catastrophizing. Self-Compassion is a useful attitude in order to regulate emotions, to be able to accept the experience that one is going through and to improve self-care in general population. Cognitive-behavioral programs (CBT) have already demonstrated that they are effective in order to reduce catastrophizing and passive coping with pain. However, effects of Mindful Self-Compassion interventions (based on mindfulness skills but not only) on chronic pain condition are still unknown.

Neff and Germer have developed a specific program to enhance self-compassion named Mindful Self-Compassion (MSC) that could be helpful to people with clinical problems. In spite of promising results of this interventions based on acceptation and self-compassion, its effectiveness on chronic pain conditions remains still unclear.

Investigator's principal hypothesis is: MSC program will be, at least, as effective as CBT program in order to improve quality of life, self-compassion, self-care and acceptance capacity; and as effective as CBT to reduce catastrophizing, anxiety and depression in a chronic pain patients sample.

Moreover, investigators also hypothesize that MSC program will be, at least, as effective as CBT program in order to maintain the achieved benefits in a 6 months follow-up.

Investigators will conduct a Randomized Controlled Trial with two treatment arms in a chronic pain sample of patients of Hospital Universitario La Paz, Madrid.

Both interventions will have 8 sessions, weekly frequency, duration of 2 hours and a half per session, and both programs will be conducted by clinical experts.

Investigators will asses levels of anxiety, depression, catastrophizing, pain interference, pain intensity, self-compassion and quality of life at the beginning of the intervention, at the end of the intervention, and a 6 months follow-up. Investigators also will administer a socio-demographic questionnaire at the beginning of the intervention to collect data about age, gender and pain characteristics.

After all recollection of data is done, investigators will conduct statistic analysis in order to accept or refuse their hypothesis.

Conditions
Chronic Pain
Being tested
MSC, CBT
Keywords
Mindfulness, Self-Compassion, Chronic Pain, Psychological Intervention, Cognitive-Behavioural therapy, acceptance, catastrophising, Self-Care, Quality of life
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MSCBehavioural

    Mindfulness and Self-Compassion training

  • CBTBehavioural

    Cognitive-behavioural techniques training

Study groups in NCT03386422
Study groupRoleWhat they receive
Mindfulness Self-Compassion Intervention MSCExperimentalMindfulness Self-Compassion (MSC) is a standardized program to increase self-compassion. It has been developed by Neff and Germer. The structure of the program is similar to de Mindfulness-Based Stress Reduction program (MBSR), with duration of sessions between 2 and 2 hours and a half. The frequency of the sessions is one per week for 8 weeks, with practical and experiential exercices in sessions and between sessions. The MSC program focuses primary on helping patients to develop self-compassion, and it includes Mindfulness just as a secondary component. The MSC program will be conducted by a clinician trained in this specific program.
Receives: Behavioral: MSC
Cognitive-Behavioural Intervention CBTActive comparatorIt has been adapted a Cognitive-Behavioural Intervention for Chronic Pain by Moix and Kovacs. Our program will have 8 sessions, with duration of sessions between 2 and 2 hours and a half. The frequency of the sessions is one per week for 8 weeks, with homework between sessions. During these 8 sessions we will train the following techniques: psychoeducation about pain, relaxation training, cognitive restructuring training, solving problem training, psychoeducation about emotions, interpersonal skills and time organization.
Receives: Behavioral: CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-Compassion

    Self-Compassion Scale (SCS, long version). Self-compassion and Self-care. Self-kindness, Common Humanity and Mindfulness. 26 items. Total score and 3 sub-scores from 1 to 5. Likert scale from 1 to 5.

    Measured: Up to 8 weeks

Secondary outcomes (22)
  1. Acceptance

    Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.

    Measured: Up to 8 weeks

  2. Acceptance

    Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.

    Measured: In a 6 months follow-up

  3. Acceptance

    Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.

    Measured: Day 1 of the intervention

  4. Pain Interference

    Pain interference in daily life. Brief Pain Inventory (BPI): pain intensity and impact of pain in daily life. Investigators will use Impact in daily life sub-scale (7 items). Scores are from 0 to10.

    Measured: Up to 8 weeks

  5. Pain Interference

    Pain interference in daily life. Brief Pain Inventory (BPI): pain intensity and impact of pain in daily life. Investigators will use Impact in daily life sub-scale (7 items). Scores are from 0 to10.

    Measured: In a 6 months follow-up

  6. Pain Interference

    Pain interference in daily life. Brief Pain Inventory (BPI): pain intensity and impact of pain in daily life. Investigators will use Impact in daily life sub-scale (7 items). Scores are from 0 to10.

    Measured: Day 1 of the intervention

  7. Pain Intensity

    Analogical Visual Scale. From 0 to 10 scores.

    Measured: Up to 8 weeks.

  8. Pain Intensity

    Analogical Visual Scale. From 0 to 10 scores.

    Measured: In a 6 months follow-up

  9. Pain Intensity

    Analogical Visual Scale. From 0 to 10 scores.

    Measured: Day 1 of the intervention

  10. Catastrophising

    Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.

    Measured: Up to 8 weeks.

  11. Catastrophising

    Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.

    Measured: In a 6 months follow-up

  12. Catastrophising

    Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.

    Measured: Day 1 of the intervention

  13. Quality of life

    Health-Related Quality Of Life, Short Form (SF-36). 36 items. 8 sub-scores, no total score. Physical function, physical role, body pain, general state of health, vitality, social function, emotional role and mental health.

    Measured: Up to 8 weeks.

  14. Quality of life

    Health-Related Quality Of Life, Short Form (SF-36). 36 items. 8 sub-scores, no total score. Physical function, physical role, body pain, general state of health, vitality, social function, emotional role and mental health.

    Measured: In a 6 months follow-up

  15. Quality of life

    Health-Related Quality Of Life, Short Form (SF-36). 36 items. 8 sub-scores, no total score. Physical function, physical role, body pain, general state of health, vitality, social function, emotional role and mental health.

    Measured: Day 1 of the intervention

  16. Anxiety and Depression

    Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.

    Measured: Up to 8 weeks.

  17. Anxiety and Depression

    Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.

    Measured: In a 6 months follow-up

  18. Anxiety and Depression

    Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.

    Measured: Day 1 of the intervention

  19. Satisfaction with the treatment

    Satisfaction with the treatment (CRES-4). 4 questions. Scores from 0 to 300. The higher the punctuation, the higher satisfaction with treatment.

    Measured: Up to 8 weeks.

  20. Adherence to the treatment

    Adherence to the treatment (Number of sessions that one patient attends)

    Measured: Up to 8 weeks.

  21. Self-Compassion

    Self-Compassion Scale (SCS, long version). Self-compassion and Self-care. Self-kindness, Common Humanity and Mindfulness. 26 items. Total score and 3 sub-scores from 1 to 5. Likert scale from 1 to 5.

    Measured: In a 6 months follow-up

  22. Self-Compassion

    Self-Compassion Scale (SCS, long version). Self-compassion and Self-care. Self-kindness, Common Humanity and Mindfulness. 26 items. Total score and 3 sub-scores from 1 to 5. Likert scale from 1 to 5.

    Measured: Day 1 of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2017
  2. Study start3 Feb 2017
  3. Primary completion7 Dec 2018
  4. Study completion30 Dec 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03386422
Sponsor's protocol ID
1
Status last verified
May 2020
First submitted
8 Dec 2017
Last updated
5 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing MSC and CBT in people with Chronic Pain, run by Instituto de Investigación Hospital Universitario La Paz 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 6 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 5 May 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?

Self-Compassion (time frame: Up to 8 weeks). 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 5 May 2020.

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