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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00118430 |
Purpose
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Stepped Care for Affective Disorders and Musculoskeletal Pain |
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | August 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Stepped Care: Experimental
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 with a physician-investigator to review cases, the physician-investigator will be available at all times 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).
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Usual Care: Active Comparator
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.
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No Treatment: No Intervention
Participants without depression group
|
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Indiana University School of Medicine, Regenenstrief Institute ( Kurt Kroenke, PI ) |
| Study ID Numbers: | R01 MH71268, DSIR 83-ATAS |
| Study First Received: | July 6, 2005 |
| Last Updated: | August 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00118430 History of Changes |
| Health Authority: | United States: Federal Government |
|
Back Pain Knee Pain Hip Pain Stepped Care |
Antidepressant Relaxation Techniques Exercise |
|
Depression Psychotropic Drugs Pain Depressive Disorder Back Pain Citalopram Paroxetine Duloxetine Behavioral Symptoms |
Fluoxetine Mental Disorders Nortriptyline Venlafaxine Mood Disorders Sertraline Dexetimide Antidepressive Agents |
|
Depression Mental Disorders Therapeutic Uses Psychotropic Drugs Mood Disorders |
Depressive Disorder Central Nervous System Agents Pharmacologic Actions Antidepressive Agents Behavioral Symptoms |
