Combined Interventions for Treating Depression and Chronic Back Pain
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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 |
- 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: 1 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: 2 Standard of Care
Participants will receive care as usual from their health care provider.
|
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.
|
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 |
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 More Information
No publications provided
| Responsible Party: | Michael R. VonKorff, ScD, Group Health Cooperative |
| ClinicalTrials.gov Identifier: | NCT00158275 History of Changes |
| Other Study ID Numbers: | R34 MH70642, DSIR 83-ATAS |
| Study First Received: | September 7, 2005 |
| Last Updated: | November 4, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Cognitive behavioral therapy Problem solving therapy CBT |
Additional relevant MeSH terms:
|
Back Pain Depression Depressive Disorder Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Behavioral Symptoms |
Mood Disorders Mental Disorders Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013