Clinical Trial: Care Intensification for Depression and Musculoskeletal Pain

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

Stepped care involves treatment that is intensified based on patient nonresponse. This study will determine the effectiveness of a stepped care approach in treating depression and reducing pain.
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

Further Study Details: 
Primary Outcomes: Pain; depressive symptoms
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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00118430

Shawn C. Hoke, BA      317-554-0000  Ext. 2604    schoke@iupui.edu

Indiana
      Indiana University Medical Center, Indianapolis,  Indiana,  46202,  United States; Recruiting
Kurt Kroenke, MD  317-630-7447    kkroenke@regenstrief.org 
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

Study chairs or principal investigators

Kurt Kroenke, MD,  Principal Investigator,  Indiana University   

More Information

Study ID Numbers:  MH-71268-01
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



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