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Clinical Trials/NCT00158275
NCT00158275
Completed
Not Applicable

Integrated Care for Depression and Chronic Back Pain

Kaiser Permanente1 site in 1 country71 target enrollmentOctober 2004

Overview

Phase
Not Applicable
Intervention
Cognitive behavioral therapy
Conditions
Back Pain
Sponsor
Kaiser Permanente
Enrollment
71
Locations
1
Primary Endpoint
Depression patient health questionnaire
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study will determine the effectiveness of an intervention consisting of combined strategies in reducing the symptoms of both depression and chronic back pain.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2004
End Date
August 2006
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Integrated Intervention

Participants 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.

Intervention: Cognitive behavioral therapy

Integrated Intervention

Participants 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.

Intervention: Antidepressants

Integrated Intervention

Participants 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.

Intervention: Problem solving therapy

Outcomes

Primary Outcomes

Depression patient health questionnaire

Time Frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment

Back pain limitations

Time Frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment

Roland disability score

Time Frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment

Study Sites (1)

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