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

NCT03386422 | Completed DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Chronic Pain

Keywords

Mindfulness; Self-Compassion; Chronic Pain; Psychological Intervention; Cognitive-Behavioural therapy; acceptance; catastrophising; Self-Care; Quality of life

Outcome Measures

Primary Outcomes (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.

  Up to 8 weeks

Secondary Outcomes (22)

• Acceptance

  Up to 8 weeks

• Acceptance

  In a 6 months follow-up

• Acceptance

  Day 1 of the intervention

• Pain Interference

  Up to 8 weeks

• Pain Interference

  In a 6 months follow-up

Other Outcomes (11)

• Socio- demographic Data: Number of visited doctors.

  Day 1 of the intervention

• Socio- demographic Data: Number of visits to emergency units.

  Day 1 of the intervention

• Socio- demographic Data: course of pain expectation.

  Day 1 of the intervention

Study Arms (2)

Mindfulness Self-Compassion Intervention MSC

EXPERIMENTAL

Mindfulness 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.

Behavioral: MSC

Cognitive-Behavioural Intervention CBT

ACTIVE COMPARATOR

It 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.

Behavioral: CBT

Interventions

MSC BEHAVIORAL

Mindfulness and Self-Compassion training

Mindfulness Self-Compassion Intervention MSC

CBT BEHAVIORAL

Cognitive-behavioural techniques training

Cognitive-Behavioural Intervention CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz.

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beatriz Rodríguez Vega

  Hospital Universitario La Paz. Universidad Autónoma de Madrid.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatry. PhD.

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 29, 2017
• Study Start: February 3, 2017
• Primary Completion: December 7, 2018
• Study Completion: December 30, 2018
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

ES (1)