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Completed

NCT Number: NCT00158275

Combined Interventions for Treating Depression and Chronic Back Pain

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

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Key information

Age range

25 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Health Cooperative

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.

Antidepressants

Drug

Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.

Problem solving therapy

Behavioral

Problem solving therapy identifies problems that interfere with everyday functions and that contribute to depression and disability. The treatment then provides compensatory strategies that are designed to bypass the person's cognitive limitations and to improve adaptive functioning in the home environment.

Primary outcomes

  1. Depression patient health questionnaire

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

  2. Back pain limitations

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

  3. Roland disability score

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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Integrated Care for Depression and Chronic Back Pain

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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