Clinical Trial: Combined Interventions for Treating Depression and Chronic Back Pain

This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) September 2005

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00158275

Purpose

This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.
Condition Intervention
Back Pain
Depression
 Behavior: Cognitive behavioral therapy
 Drug: Antidepressants
 Behavior: Problem solving therapy

MedlinePlus related topics:  Back Pain;   Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Integrated Care for Depression and Chronic Back Pain

Further Study Details: 
Primary Outcomes: Depression patient health questionnaire; back pain limitations; Roland disability score
Expected Total Enrollment:  100

Study start: October 2004;  Expected completion: July 2006

The relationship between depression and back pain is complex. Depression is the most common mental condition associated with chronic back pain. Despite this relationship, many patients with depression and back pain seek treatment only for one of the two conditions, which can worsen the untreated condition. An intervention that reduces the symptoms of both depression and back pain is needed. This study will determine the effectiveness of an integrated intervention in reducing both back pain and depression symptoms.

Participants will be randomly assigned to receive either an integrated intervention or standard of care for 6 months. Participants in the integrated intervention group will receive cognitive behavioral therapy for back pain and antidepressants and/or problem solving therapy for depression. Study visits will initially occur once a week and then taper to once every 2 weeks for the 6-month duration; the time of tapering will depend on participant response to treatment and will be at the investigator’s discretion. Depression and back pain symptoms will be assessed in all participants at study entry, at the end of treatment, and 6 months after the end of treatment. The study entry and study completion assessments will occur during study visits. The last assessment will be a telephone interview.

Eligibility

Ages Eligible for Study:  25 Years   -   74 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Roland back pain score of 7 or greater
  • Diagnosis of major depression
  • Plan to stay enrolled in Group Health Cooperative for the duration of the study and 1 year after the study

Exclusion Criteria:

  • Prior surgery
  • Cauda equina syndrome (compression and paralysis of nerve roots)
  • Schizophrenia or bipolar disorder treatment within 2 years prior to study entry
  • Current or prior psychiatric or psychological care for back pain or depression
  • At high risk for suicide

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00158275

Michael R. VonKorff, ScD      206-287-2874    vonkorff.m@ghc.org

Washington
      Group Health Cooperative, Seattle,  Washington,  98101,  United States; Recruiting
Michael R. VonKorff, ScD  206-287-2874    vonkorff.m@ghc.org 
Benjamin Balderson, PhD  206-287-2803    balderson.b@ghc.org 
Michael R. VonKorff, ScD,  Principal Investigator
Benjamin Balderson, PhD,  Sub-Investigator
Elizabeth H.B. Lin, MD, MPH,  Sub-Investigator

Study chairs or principal investigators

Michael R. VonKorff, ScD,  Principal Investigator,  Group Health Cooperative   

More Information

Study ID Numbers:  1R34-MH070642
Last Updated:  September 10, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00158275
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13



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