Combined Interventions for Treating Depression and Chronic Back Pain - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00158275

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

MedlinePlus related topics: Antidepressants Back Pain Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Integrated Care for Depression and Chronic Back Pain

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

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
1 Integrated Intervention: 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.	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.
2 Standard of Care: No Intervention 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.

Arms

Assigned Interventions

1 Integrated Intervention: 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.

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.

2 Standard of Care: No Intervention

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158275

Locations

United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Michael R. VonKorff, ScD

Group Health Cooperative

More Information

No publications provided

Responsible Party:	Group Health Cooperative ( Michael R. VonKorff, ScD )
Study ID Numbers:	R34 MH70642, DSIR 83-ATAS
Study First Received:	September 7, 2005
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00158275 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Cognitive behavioral therapy
Problem solving therapy
CBT

Study placed in the following topic categories:

Signs and Symptoms
Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders
Neurologic Manifestations

Pain
Depressive Disorder
Back Pain
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Nervous System Diseases
Psychotropic Drugs
Pain
Depressive Disorder
Back Pain
Pharmacologic Actions
Behavioral Symptoms

Signs and Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Neurologic Manifestations
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 06, 2009