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Multidisciplinary Group Based Treatment of Patients With Chronic Pain

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ClinicalTrials.gov Identifier: NCT02658474
Recruitment Status : Recruiting
First Posted : January 18, 2016
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
University of Tromso

Brief Summary:

The purpose of this study is to determine whether group based Acceptance and Commitment Therapy (ACT) at a university hospital clinic is superior to treatment in a primary care setting among patients with chronic pain.

Hypothesis:

i) A group based ACT treatment leads to less pain and greater Health Related Quality of Life (HRQOL) in patients with chronic pain than treatment in a primary care setting.

ii) The improvement in pain and HRQOL is mediated through an increased degree of pain willingness and involvement in activities.

iii) Improvement of pain and HRQOL after the two treatments is associated with demographic, psychosocial and somatic characteristics.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Acceptance and Commitment Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multidisciplinary Group Based Treatment of Patients With Chronic Pain. A Randomized Controlled Trial Comparing Acceptance Commitment Therapy and Treatment in a Primary Care Setting
Study Start Date : August 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: ACT-group
Group based Acceptance and Commitment Therapy. The patients will attend to three sessions which last for three days. Between the sessions the patients will train at home on ACT related topics. The whole intervention will last for three months.
Behavioral: Acceptance and Commitment Therapy
Group based Acceptance and Commitment Therapy

No Intervention: Primary care
Treatment in a primary care setting.



Primary Outcome Measures :
  1. Group difference in pain intensity [ Time Frame: 3 months after baseline ]
    Continuous variable (Numeric rating scale) analyzed by Mixed Model

  2. Group difference in pain intensity [ Time Frame: 6 months after baseline ]
    Continuous variable (Numeric rating scale) analyzed by Mixed Model

  3. Group difference in health related quality of life [ Time Frame: 3 months after baseline ]
    Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model

  4. Group difference in health related quality of life [ Time Frame: 6 months after baseline ]
    Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model


Secondary Outcome Measures :
  1. Change from baseline in pain intensity [ Time Frame: 3 months after baseline ]
    Continuous variable (Numeric rating scale) analyzed by Mixed Model

  2. Change from baseline in pain intensity [ Time Frame: 6 months after baseline ]
    Continuous variable (Numeric rating scale) analyzed by Mixed Model

  3. Change from baseline in pain intensity [ Time Frame: 12 months after baseline ]
    Continuous variable (Numeric rating scale) analyzed by Mixed Model

  4. Change from baseline in health related quality of life [ Time Frame: 3 months after baseline ]
    Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model

  5. Change from baseline in health related quality of life [ Time Frame: 6 months after baseline ]
    Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model

  6. Change from baseline in health related quality of life [ Time Frame: 12 months after baseline ]
    Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model

  7. Change from baseline in pain willingness and involvement in activities [ Time Frame: 3 months after baseline ]
    The questionnaire Chronic Pain Acceptance Questionnaire (CPAQ 20) and analyzed by Mixed Model

  8. Change from baseline in pain willingness and involvement in activities [ Time Frame: 6 months after baseline ]
    The questionnaire Chronic Pain Acceptance Questionnaire (CPAQ 20) and analyzed by Mixed Model

  9. Change from baseline in pain willingness and involvement in activities [ Time Frame: 12 months after baseline ]
    The questionnaire Chronic Pain Acceptance Questionnaire (CPAQ 20) and analyzed by Mixed Model

  10. Group difference in drug consumption [ Time Frame: 6 months after baseline ]
    Number of analgesics and morphine equivalents analyzed by Mixed Model

  11. Group difference in consumption of health services [ Time Frame: 6 months after baseline ]
    Number of health services applied is counted and analyzed by Mixed Model



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Long-term pain condition over 6 months.
  • Strongest pain ≥ 4 on a scale of 0 to 10.
  • Consent competent and over 18 years
  • Motivated for group-based psychological (ACT) treatment.

Exclusion Criteria:

  • Psychiatric illness and behavioral problems, including substance abuse that prevents good group interaction
  • Severe progressive disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658474


Contacts
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Contact: Gunnvald Kvarstein, PhD Gunnvald.Kvarstein@uit.no
Contact: Lena Danielsson, MD Lena.Danielsson@unn.no

Locations
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Norway
University Hospital of North Norway Recruiting
Tromsø, Troms, Norway, 9038
Contact: Lena Danielsson    +4777669307    lena.danielsson@unn.no   
Contact: Gunnvald Kvarstein       gunnvald.kvarstein@unn.no   
Sponsors and Collaborators
University of Tromso
The Royal Norwegian Ministry of Health
Investigators
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Principal Investigator: Gunnvald Kvarstein, PhD UiT The Arctic University of Tromsø

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Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT02658474     History of Changes
Other Study ID Numbers: 2013/1880REK
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Tromso:
Chronic pain
Acceptance and Commitment Therapy
Multidisciplinary treatment
Group treatment

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms