Combined Interventions for Treating Depression and Chronic Back Pain - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 7, 2005

Last Updated Date

November 4, 2008

Start Date ^†

October 2004

Current 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 ]

Original Primary Outcome Measures ^†

Depression patient health questionnaire
back pain limitations
Roland disability score

Change History

Complete list of historical versions of study NCT00158275 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Combined Interventions for Treating Depression and Chronic Back Pain

Official Title ^†

Integrated Care for Depression and Chronic Back Pain

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Back Pain
Depression

Intervention ^†

Behavioral: Cognitive behavioral therapy
Drug: Antidepressants
Behavioral: Problem solving therapy

Study Arms / Comparison Groups

Experimental: 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.
No Intervention: Participants will receive care as usual from their health care provider.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

25 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00158275

Responsible Party

Michael R. VonKorff, ScD, Group Health Cooperative

Secondary IDs ^††

DSIR 83-ATAS

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Michael R. VonKorff, ScD

Group Health Cooperative

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.