Combined Interventions for Treating Depression and Chronic Back Pain
|ClinicalTrials.gov Identifier: NCT00158275|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Depression||Behavioral: Cognitive behavioral therapy Drug: Antidepressants Behavioral: Problem solving therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrated Care for Depression and Chronic Back Pain|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
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.
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158275
|United States, Washington|
|Group Health Cooperative|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Michael R. VonKorff, ScD||Kaiser Permanente|