Facilitating the Adoption of Evidence-Based Depression Management in Substance Use Treatment Programs

Substance-Related Disorders Clinical Trial

Official title:

Translating Depression Guidelines Into Substance Abuse Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137306
• Other study ID #: SUT 02-211
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2005
• Last updated: April 6, 2015
• Start date: January 2004
• Est. completion date: October 2006

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• Mood Disorders
• Substance-Related Disorders

Intervention

Procedure:
• Facilitate evidence-based treatment for depression

Locations

Country	Name	City	State
United States	VA Gulf Coast Veterans Health Care System	Biloxi	Mississippi
United States	G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS	Jackson	Mississippi
United States	Southeast Louisiana Veterans Health Care System, New Orleans, LA	New Orleans	Louisiana
United States	Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR	No. Little Rock	Arkansas
United States	Oklahoma City, OK	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program: extent, quality of adoption of protocolPatient: scores on-depression, substance use, and functioning scales			No
Secondary	Programs: Staff satisfaction with protocol/intervention Patients: medication adherence			No