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Combined Interventions for Treating Depression and Chronic Back Pain

Primary Purpose

Back Pain, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy
Antidepressants
Problem solving therapy
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Cognitive behavioral therapy, Problem solving therapy, CBT

Eligibility Criteria

25 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Group Health Cooperative

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated Intervention

Standard of Care

Arm Description

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.

Participants will receive care as usual from their health care provider.

Outcomes

Primary Outcome Measures

Depression patient health questionnaire
Back pain limitations
Roland disability score

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00158275
Brief Title
Combined Interventions for Treating Depression and Chronic Back Pain
Official Title
Integrated Care for Depression and Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Depression
Keywords
Cognitive behavioral therapy, Problem solving therapy, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants will receive care as usual from their health care provider.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
Cognitive behavioral therapy focuses on identifying and eliminating maladaptive beliefs and thoughts.
Intervention Type
Drug
Intervention Name(s)
Antidepressants
Intervention Description
Antidepressant drugs try to eliminate symptoms of depression such as persistent sadness and disinterest in normal or pleasurable activities.
Intervention Type
Behavioral
Intervention Name(s)
Problem solving therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression patient health questionnaire
Time Frame
Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Title
Back pain limitations
Time Frame
Measured at study entry, at the end of treatment, and 6 months after the end of treatment
Title
Roland disability score
Time Frame
Measured at study entry, at the end of treatment, and 6 months after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. VonKorff, ScD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Cooperative
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combined Interventions for Treating Depression and Chronic Back Pain

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