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Clinical Trials/NCT04057144
NCT04057144
Completed
N/A

Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain: A Randomized Controlled Efficacy and Mediator Study

St. Olavs Hospital4 sites in 1 country486 target enrollmentAugust 20, 2020
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
St. Olavs Hospital
Enrollment
486
Locations
4
Primary Endpoint
pain intensity measured by the Norwegian Brief Pain Inventory (BPI)
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

As non-pharmacological alternatives, psychosocial treatments have been recommended for chronic pain management. One such treatment is Acceptance and Commitment Therapy (ACT). ACT is a cognitive behavior therapy based on Relational Frame Theory, a comprehensive theory about language and cognition. This treatment intends to help patients identify values ("what is truly meaningful to them") and to set goals and take action according to their values. ACT has research support in the treatment of several mental health problems. Moreover patients are taught mindfulness skills to increase acceptance of pain, thoughts and feelings so that these will have less impact on functioning and action. Among patients with chronic pain, several small clinical trials have shown that ACT is more effective than other treatments in terms of increasing function and improving mental health. ACT in combination with mindfulness training has not been tested so far. Further methodologically robust trials are required. This study will therefore examine whether ACT is more effective for chronic pain than an education program, and whether adding daily mindfulness training will improve the outcome, in a large sample of patients from four multidisciplinary pain centers.

Registry
clinicaltrials.gov
Start Date
August 20, 2020
End Date
August 30, 2024
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • referred to one of the pain clinics in Oslo (200), Trondheim (200), Bergen (100) or Tromsø (100)
  • primary diagnosis of chronic pain lasting for at least 6 months

Exclusion Criteria

  • severe somatic disease
  • severe mental disorder (ongoing mania, psychosis, suicidal ideation, substance abuse/addiction
  • not able to communicate in Norwegian
  • needing 24-hour personal assistance

Outcomes

Primary Outcomes

pain intensity measured by the Norwegian Brief Pain Inventory (BPI)

Time Frame: 44 weeks after end of treatment

the Brief Pain Inventory includes four 0-10 numerical rating scales: for 'pain now', and for 'least pain', 'worst pain', and 'average pain' during the last 24 hours, with 0 = no pain to 10 = pain as bad as you can imagine. A pain severity index is calculated by adding the scores on the pain severity items

Secondary Outcomes

  • physical function(3 years after end of treatment)
  • pain intensity measured by the Norwegian Brief Pain Inventory (BPI)(3 years after end of treatment)
  • mental health(3 years after end of treatment)

Study Sites (4)

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