Combined Interventions for Treating Depression and Chronic Back Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00158275
First received: September 7, 2005
Last updated: July 14, 2014
Last verified: July 2014
  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
Behavioral: Cognitive behavioral therapy
Drug: Antidepressants
Behavioral: Problem solving therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Care for Depression and Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Depression patient health questionnaire [ Time Frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment ] [ Designated as safety issue: No ]
  • Back pain limitations [ Time Frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment ] [ Designated as safety issue: No ]
  • Roland disability score [ Time Frame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: October 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Cognitive behavioral therapy
Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.
Drug: Antidepressants
Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.
Behavioral: Problem solving therapy
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.
No Intervention: Standard of Care
Participants will receive care as usual from their health care provider.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158275

Locations
United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Michael R. VonKorff, ScD Group Health Cooperative
  More Information

No publications provided

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00158275     History of Changes
Other Study ID Numbers: R34 MH70642, R34MH070642, DSIR 83-ATAS
Study First Received: September 7, 2005
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:
Cognitive behavioral therapy
Problem solving therapy
CBT

Additional relevant MeSH terms:
Back Pain
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014