Biomarkers in Pain and Pain Treatment

Study Overview
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Brief Summary
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The goal of this research project is to explore if levels of inflammation predict levels of comorbid mood disorders and treatment success in chronic pain patients. More knowledge in this respect will advance our understanding of chronic pain and comorbid syndromes, and facilitate subgroupings of patients based on the presence and/or level of low-grade inflammation. This research is an important step towards finding an explanation to why treatment effects following behavioral interventions differ across individuals, and generate new hypothesis regarding novel treatment approaches. The specific aims are: 1) to explore if baseline levels of inflammatory biomarkers predict the effects of behavioral intervention and 2) to investigate if baseline levels of inflammatory biomarkers are associated with psychological co-morbidity (e.g. depression, anxiety and fatigue) in patients with chronic pain.

Official Title
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The Effect of Inflammation on Psychological Comorbidity and Behavioral Treatment in Chronic Pain

Conditions
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Chronic Pain, Inflammation

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to a specialist clinic within pain management Equal to or older than 18 years Chronic pain (> 6 months) The pain is refractory The pain results in significant functional limitations Stable medication in the last 2 months and no planned changes in medication (except possibly discontinuation or lowering of current dose) Exclusion Criteria: Spontaneous improvement can be expected (without treatment) Psychiatric comorbidity a) is deemed to be the main reason for the restrictions, or b) should be promptly evaluated and possibly treated, or c) may adversely affect the treatment given in the context of the study Significant risk of suicide Poor teamwork, defined as repeated missed appointments during the assessment / investigation phase Language difficulties (Swedish)

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Acceptance and Commitment Therapy|The main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success | The Pain Disability Index | At last psychological session (3 months post baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbid psychological problems | PHQ-9 | At first psychological session (baseline) | 
| Blood biomarkers as an effect of treatment | Pro-inflammatory cytokines | At last psychological session (3 months post baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychoneuroimmunology