Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Behavioral: ACTBehavioral: Education programBehavioral: mindfulness exercises and audio recordings
- Registration Number
- NCT04057144
- Lead Sponsor
- St. Olavs Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 486
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACT without mindfulness ACT 4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8 ACT with mindfulness ACT 4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8 ACT with mindfulness mindfulness exercises and audio recordings 4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8 Education program Education program Self-management education program during 8 weeks in groups of 8.
- Primary Outcome Measures
Name Time Method pain intensity measured by the Norwegian Brief Pain Inventory (BPI) 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 Outcome Measures
Name Time Method pain intensity measured by the Norwegian Brief Pain Inventory (BPI) 3 years 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
physical function 3 years after end of treatment according to the SF-36 Health Survey
mental health 3 years after end of treatment according to the SF-36 Health Survey
Trial Locations
- Locations (4)
Haukeland universitetssykehus
🇳🇴Bergen, Norway
Oslo universitetssykehus
🇳🇴Oslo, Norway
Norges arktiske universitet
🇳🇴Tromsø, Norway
St Olavs Hospital
🇳🇴Trondheim, Norway