- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137306
Facilitating the Adoption of Evidence-Based Depression Management in Substance Use Treatment Programs
Translating Depression Guidelines Into Substance Abuse Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Comorbid depression has been consistently linked to worse outcomes for patients in substance abuse treatment programs. Practice guidelines recommend pharmacotherapy for comorbid depression if symptoms persist after a 4-week "wash-out" period for detoxification (e.g., Veterans Health Administration; American Psychiatric Association). Medications may be considered earlier if a patient has current symptoms and a history of major depressive disorder (MDD) during periods of sobriety. Current efficacy data suggest that antidepressant medication can improve both depression and substance use outcomes among comorbid patients Guideline-concordant use of antidepressant medication for persons with comorbid substance use and depressive disorders, however, is not routine in many VA substance abuse treatment settings.
Objectives:
This study seeks to develop, implement, and test an organizational intervention in VA substance abuse treatment settings to establish guideline-concordant treatment of comorbid depression. The intervention will assist "intervention" programs in their own implementation of a guidelines-based treatment algorithm to improve the recognition of depression and initiation of pharmacotherapy.
Methods:
Substance abuse treatment programs in the South Central VISN were matched on program characteristics and current depression management practices (n = 4), and "intervention" sites were randomly chosen from each pair. Phase 1 (now completed) of the study analyzed the barriers and facilitators to translation of depression management in participating facilities, and used these data to inform the development of the translation intervention, its implementation tools, and the depression algorithm. The translation intervention adopted in this plan was based on the PRECEDE model of organizational behavior change and included provider education, use of local champions, feedback of screening data, and patient education/activation. The depression management algorithm and intervention was developed with input from programs staff and an Advisory Panel of depression management and translation experts. Phase 2 of the study implemented and tested the intervention. The evaluation in examining program- and provider-level outcomes. Program-level outcomes include feasibility, extent of adoption of the algorithm, and provider/organizational attitudes and beliefs about the intervention's design and effectiveness. Patient-level outcomes include depressive symptoms, substance use outcomes, medication adherence, quality of life, and services use.
Status:
Phase 1 of the study is complete. Phase 2 is near complete.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Arkansas
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No. Little Rock, Arkansas, United States, 72114-1706
- Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Southeast Louisiana Veterans Health Care System, New Orleans, LA
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Mississippi
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Biloxi, Mississippi, United States, 39531
- VA Gulf Coast Veterans Health Care System
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Jackson, Mississippi, United States, 39216
- G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
-
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma City, OK
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Programs: VA's offering residential or intensive outpatient treatment for substance-related disorders in VISN 16 Patients: Veterans in residential or intensive outpatient treatment for substance-related disorders; positive screen for non-substance-induced depressive disorder
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Program: extent, quality of adoption of protocolPatient: scores on-depression, substance use, and functioning scales
|
Secondary Outcome Measures
Outcome Measure |
---|
Programs: Staff satisfaction with protocol/intervention Patients: medication adherence
|
Collaborators and Investigators
Investigators
- Principal Investigator: Geoffrey M. Curran, PhD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Publications and helpful links
General Publications
- Curran GM, Mukherjee S, Allee E, Owen RR. A process for developing an implementation intervention: QUERI Series. Implement Sci. 2008 Mar 19;3:17. doi: 10.1186/1748-5908-3-17.
- Curran GM, Kirchner JE, Worley M, Rookey C, Booth BM. Depressive symptomatology and early attrition from intensive outpatient substance use treatment. J Behav Health Serv Res. 2002 May;29(2):138-43. doi: 10.1007/BF02287700.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUT 02-211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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