Combined Interventions for Treating Depression and Chronic Back Pain

Not Applicable

Completed

• Conditions: Depression; Back Pain
• Interventions: Behavioral: Cognitive behavioral therapy; Drug: Antidepressants; Behavioral: Problem solving therapy

• Registration Number: NCT00158275
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Intervention	Cognitive behavioral therapy	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.
Integrated Intervention	Antidepressants	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.
Integrated Intervention	Problem solving therapy	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.

Primary Outcome Measures

Name	Time	Method
Back pain limitations	Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Roland disability score	Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Depression patient health questionnaire	Measured at study entry, at the end of treatment, and 6 months after the end of treatment

Trial Locations

Locations (1)

Group Health Cooperative; 🇺🇸 Seattle, Washington, United States