Depression |
Depression/depressive Disorders |
Clinical Trial: Care Intensification for Depression and Musculoskeletal Pain
This study is currently recruiting patients.
|
Purpose
| Condition | Intervention |
|---|---|
| Pain Depression | Behavior: Stepped care Drug: Antidepressants |
MedlinePlus related topics: Depression; Pain
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Stepped Care for Depression and Musculoskeletal Pain
Secondary Outcomes: Quality of life; health care usage and cost
Expected Total Enrollment: 500
Study start: September 2004
In the United States, pain accounts for nearly 20% of all primary health care visits. In the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. Studies have shown that at least one-third of patients with pain also suffer from depression. It has not been determined whether treatments for depression are effective in patients with comorbid pain and depression. The "Stepped Care for Affective Disorders and Musculoskeletal Pain" (SCAMP) study will determine the most effective treatment for patients with pain and depression.
This study will last 12 months and will comprise depressed and nondepressed participants. Nondepressed participants will receive no treatment. Depressed patients will be randomly assigned to receive standard of care or stepped care for 12 weeks. Standard of care may include cognitive therapy, antidepressant treatment, or other treatments. The stepped care group will receive 12 weeks of antidepressant treatment. Participants who respond to antidepressant treatment will continue their treatment for the duration of the study. Participants who do not respond to the treatment after 12 weeks will receive 6 weekly pain self-management sessions. During these sessions, an educator will teach participants how to manage their pain through exercise and relaxation techniques. Self-report scales and questionnaires will be used to assess participants'''' pain, depressive symptoms, health care usage and costs, and quality of life. Depressed participants will undergo assessments at study start and at Months 1, 3, 6, and 12. Nondepressed participants will undergo assessments at study start and at Months 3 and 12.
Study hypotheses: 1) Stepped care is more effective than usual care in improving depression and pain. 2) Stepped care is more effective than usual care in improving health-related quality of life, negative pain beliefs and behaviors, reduced opiate use, and health care costs. 3) Patients with musculoskeletal pain who are not depressed at baseline will have an incidence of depression less than 20% over 12 months of follow-up, characteristics that can be identified as risk factors for incident depression, baseline characteristics distinguishing them from depressed patients, and better pain and health status outcomes, compared to depressed patients.
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- Moderate or severe pain in the back, hips, or knees for at least 3 months prior to study entry
- History of or current use of at least one medication for pain
- English-speaking
Exclusion Criteria:
- Moderate to severe cognitive impairment
- Schizophrenia or other psychotic disorders
- Receiving disability benefits for pain
- Anticipated life expectancy less than 12 months
- Pregnancy
Location and Contact Information
Indiana
Indiana University Medical Center, Indianapolis, Indiana, 46202, United States; Recruiting
Shawn C. Hoke, BA 317-554-0000 Ext. 2604 schoke@iupui.edu
Kurt Kroenke, MD, Principal Investigator
Matt Bair, MD, Sub-Investigator
Teresa Damush, PhD, Sub-Investigator
Kurt Kroenke, MD, Principal Investigator, Indiana University
More Information
Record last reviewed: July 2005
Last Updated: July 21, 2005
Record first received: July 8, 2005
ClinicalTrials.gov Identifier: NCT00118430
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- "Care Managers" Help Depressed Elderly Reduce Suicidal Thoughts (National Institutes of Health)
- 5-HTP:Nature''s Serotonin Solution? (HealthWorld)

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