This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Stepped Care for Depression and Musculoskeletal Pain

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Indiana University Identifier:
First received: July 6, 2005
Last updated: March 28, 2017
Last verified: March 2017
This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.

Condition Intervention Phase
Pain Depression Behavioral: Stepped Care Drug: Antidepressants Drug: Usual Care Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stepped Care for Affective Disorders and Musculoskeletal Pain

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Brief Pain Inventory Interference [ Time Frame: Measured at Year 1 ]
    The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).

  • HSCL-20 Depression Severity [ Time Frame: Measured at Year 1 ]
    This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)

Secondary Outcome Measures:
  • Graded Chronic Pain Scale Disability Score [ Time Frame: Measured at Year 1 ]
    This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)

  • Primary Care Visits [ Time Frame: Measured at Year 1 ]

Enrollment: 500
Study Start Date: September 2004
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stepped Care
Stepped care group
Behavioral: Stepped Care
Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.
Drug: Antidepressants
Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg).
Active Comparator: Usual Care
Treatment as usual group
Drug: Usual Care
This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.
Other Name: Standard Care
No Intervention: No Treatment
Participants without depression group

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00118430

United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
National Institute of Mental Health (NIMH)
Principal Investigator: Kurt Kroenke, MD Indiana University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Indiana University Identifier: NCT00118430     History of Changes
Other Study ID Numbers: R01MH071268 ( U.S. NIH Grant/Contract )
Study First Received: July 6, 2005
Results First Received: May 23, 2016
Last Updated: March 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data has been published in multiple publications. Should others wish access to data for publication reasons, we are willing to share

Keywords provided by Indiana University:
Back Pain
Knee Pain
Hip Pain
Stepped Care
Relaxation Techniques

Additional relevant MeSH terms:
Depressive Disorder
Musculoskeletal Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antidepressive Agents
Psychotropic Drugs processed this record on September 21, 2017