Acceptance and Commitment Therapy With and Without Enhanced Mindfulness Training for Chronic Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: ACT
* Behavioral: mindfulness exercises and audio recordings
* Behavioral: Education program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a three group randomized controlled trial with 162 patient in each group, six different measurement points, of which pre-treatment and 52 weeks after start of the treatment are the crucial points.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT with mindfulness<br>4-hour weekly session of acceptance and commitment therapy (ACT) with mindfulness exercises during 8 weeks in groups of 8 | Behavioral: ACT<br>* Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.<br>Behavioral: mindfulness exercises and audio recordings<br>* mindfulness exercises introduced in the ACT sessions. In addition daily home meditation exercises based on the program developed by Kabat-Zinn 2005 and with help of audio recordings.<br>|
| Experimental: ACT without mindfulness<br>4-hour weekly acceptance and commitment therapy (ACT) without mindfulness exercises during 8 weeks in groups of 8 | Behavioral: ACT<br>* Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.<br>|
| Active Comparator: Education program<br>Self-management education program during 8 weeks in groups of 8. | Behavioral: Education program<br>* Self-management education program. Information given by a qualified health professional on pain and symptom management, stress, sleep, eating habits, mental health problems. Group discussions about thoughts and experiences. communication skills and physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity measured by the Norwegian Brief Pain Inventory (BPI) | 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 | 44 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity measured by the Norwegian Brief Pain Inventory (BPI) | 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 | 8 weeks after end of treatment | 
| pain intensity measured by the Norwegian Brief Pain Inventory (BPI) | 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 | 24 weeks after end of treatment | 
| pain intensity measured by the Norwegian Brief Pain Inventory (BPI) | 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 | 3 years after end of treatment | 
| physical function | according to the SF-36 Health Survey | 8 weeks after end of treatment | 
| physical function | according to the SF-36 Health Survey | 24 weeks after end of treatment | 
| physical function | according to the SF-36 Health Survey | 44 weeks after end of treatment | 
| physical function | according to the SF-36 Health Survey | 3 years after end of treatment | 
| mental health | according to the SF-36 Health Survey | 8 weeks after end of treatment | 
| mental health | according to the SF-36 Health Survey | 24 weeks after end of treatment | 
| mental health | according to the SF-36 Health Survey | 44 weeks after end of treatment | 
| mental health | according to the SF-36 Health Survey | 3 years after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Psychotherapy, Group, Behavior Therapy