<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272893</url>
  </required_header>
  <id_info>
    <org_study_id>pni-act-2016</org_study_id>
    <nct_id>NCT03272893</nct_id>
  </id_info>
  <brief_title>Biomarkers in Pain and Pain Treatment</brief_title>
  <official_title>The Effect of Inflammation on Psychological Comorbidity and Behavioral Treatment in Chronic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rikard Wicksell</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AFA Insurance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Swedish Society of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research project is to explore if levels of inflammation predict levels of&#xD;
      comorbid mood disorders and treatment success in chronic pain patients. More knowledge in&#xD;
      this respect will advance our understanding of chronic pain and comorbid syndromes, and&#xD;
      facilitate subgroupings of patients based on the presence and/or level of low-grade&#xD;
      inflammation. This research is an important step towards finding an explanation to why&#xD;
      treatment effects following behavioral interventions differ across individuals, and generate&#xD;
      new hypothesis regarding novel treatment approaches. The specific aims are: 1) to explore if&#xD;
      baseline levels of inflammatory biomarkers predict the effects of behavioral intervention and&#xD;
      2) to investigate if baseline levels of inflammatory biomarkers are associated with&#xD;
      psychological co-morbidity (e.g. depression, anxiety and fatigue) in patients with chronic&#xD;
      pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <primary_completion_date type="Actual">December 12, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment success</measure>
    <time_frame>At last psychological session (3 months post baseline)</time_frame>
    <description>The Pain Disability Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comorbid psychological problems</measure>
    <time_frame>At first psychological session (baseline)</time_frame>
    <description>PHQ-9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood biomarkers as an effect of treatment</measure>
    <time_frame>At last psychological session (3 months post baseline)</time_frame>
    <description>Pro-inflammatory cytokines</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood biomarkers as predictor for treatment success</measure>
    <time_frame>At first psychological session (baseline)</time_frame>
    <description>Pro-inflammatory cytokines</description>
  </other_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Inflammation</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and Commitment Therapy</intervention_name>
    <description>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.</description>
    <other_name>ACT</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma, whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patients at the Karolinska Pain Center, suffering from chronic pain that does not&#xD;
        respond to any other pain treatments and affects daily functioning severely.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Referred to a specialist clinic within pain management&#xD;
&#xD;
          2. Equal to or older than 18 years&#xD;
&#xD;
          3. Chronic pain (&gt; 6 months)&#xD;
&#xD;
          4. The pain is refractory&#xD;
&#xD;
          5. The pain results in significant functional limitations&#xD;
&#xD;
          6. Stable medication in the last 2 months and no planned changes in medication (except&#xD;
             possibly discontinuation or lowering of current dose)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Spontaneous improvement can be expected (without treatment)&#xD;
&#xD;
          2. Psychiatric comorbidity a) is deemed to be the main reason for the restrictions, or b)&#xD;
             should be promptly evaluated and possibly treated, or c) may adversely affect the&#xD;
             treatment given in the context of the study&#xD;
&#xD;
          3. Significant risk of suicide&#xD;
&#xD;
          4. Poor teamwork, defined as repeated missed appointments during the assessment /&#xD;
             investigation phase&#xD;
&#xD;
          5. Language difficulties (Swedish)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rikard Wicksell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bianka Karshikoff, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda Holmström, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mats Lekander, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jenny Åström, lic psych</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska University Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Lasselin J, Kemani MK, Kanstrup M, Olsson GL, Axelsson J, Andreasson A, Lekander M, Wicksell RK. Low-grade inflammation may moderate the effect of behavioral treatment for chronic pain in adults. J Behav Med. 2016 Oct;39(5):916-24. doi: 10.1007/s10865-016-9769-z. Epub 2016 Jul 28.</citation>
    <PMID>27469518</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 24, 2020</last_update_submitted>
  <last_update_submitted_qc>February 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Rikard Wicksell</investigator_full_name>
    <investigator_title>Director of Functional Area Medical Psychology, Karolinska Univ Hospital and head of research group Behavior Medicine, KI</investigator_title>
  </responsible_party>
  <keyword>psychoneuroimmunology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272893
org study id: pni-act-2016
nct id: NCT03272893
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Treatment success
time frame: At last psychological session (3 months post baseline)
description: The Pain Disability Index
measure: Comorbid psychological problems
time frame: At first psychological session (baseline)
description: PHQ-9
measure: Blood biomarkers as an effect of treatment
time frame: At last psychological session (3 months post baseline)
description: Pro-inflammatory cytokines
measure: Blood biomarkers as predictor for treatment success
time frame: At first psychological session (baseline)
description: Pro-inflammatory cytokines
intervention type: Behavioral
intervention name: Acceptance and Commitment Therapy
description: 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.
other name: ACT
plasma, whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rikard Wicksell, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Bianka Karshikoff, PhD
role: Study Chair
affiliation: Karolinska Institutet
last name: Linda Holmström, PhD
role: Study Chair
affiliation: Karolinska Institutet
last name: Mats Lekander, PhD
role: Study Chair
affiliation: Karolinska Institutet
last name: Jenny Åström, lic psych
role: Study Chair
affiliation: Karolinska University Hospital
citation: Lasselin J, Kemani MK, Kanstrup M, Olsson GL, Axelsson J, Andreasson A, Lekander M, Wicksell RK. Low-grade inflammation may moderate the effect of behavioral treatment for chronic pain in adults. J Behav Med. 2016 Oct;39(5):916-24. doi: 10.1007/s10865-016-9769-z. Epub 2016 Jul 28.
PMID: 27469518
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Rikard Wicksell
investigator title: Director of Functional Area Medical Psychology, Karolinska Univ Hospital and head of research group Behavior Medicine, KI
mesh term: Inflammation
mesh term: Chronic Pain
sharing ipd: No