Combined Interventions for Treating Depression and Chronic Back Pain

Depression Clinical Trial

Official title:

Integrated Care for Depression and Chronic Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158275
• Other study ID #: R34MH070642
• Secondary ID: R34MH070642DSIR
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: October 11, 2017
• Start date: October 2004
• Est. completion date: August 2006

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Group Health Cooperative	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression patient health questionnaire		Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Primary	Back pain limitations		Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Primary	Roland disability score		Measured at study entry, at the end of treatment, and 6 months after the end of treatment