Clinical trial NCT00158275: Combined Interventions for Treating Depression and Chronic Back Pain
Official title: Integrated Care for Depression and Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Depression
Keywords: Cognitive behavioral therapy
Problem solving therapy
CBT
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-12
Enrollment: 71
Sex: ALL
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Depression patient health questionnaire
timeFrame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
measure: Back pain limitations
timeFrame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
measure: Roland disability score
timeFrame: Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Michael R. VonKorff, ScD
role: PRINCIPAL_INVESTIGATOR
References: