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

• ClinicalTrials.gov Identifier: NCT00137306
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Last Update Posted: April 7, 2015
• Sponsor: US Department of Veterans Affairs
• Information provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information

• First Submitted Date: August 25, 2005
• First Posted Date: August 29, 2005
• Last Update Posted Date: April 7, 2015
• Study Start Date: January 2004
• Actual Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 13, 2011): Program: extent, quality of adoption of protocolPatient: scores on-depression, substance use, and functioning scales
• Original Primary Outcome Measures (submitted: August 25, 2005): Program: extent, quality of adoption of protocol Patient: scores on-depression, substance use, and functioning scales
• Current Secondary Outcome Measures (submitted: August 25, 2005): Programs: Staff satisfaction with protocol/intervention Patients: medication adherence
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Facilitating the Adoption of Evidence-Based Depression Management in Substance Use Treatment Programs
• Official Title: Translating Depression Guidelines Into Substance Abuse Treatment
• Brief 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.

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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)

Condition

• Mood Disorders
• Substance-Related Disorders

• Intervention: Procedure: Facilitate evidence-based treatment for depression

Study Arms

Arm 1

Intervention: Procedure: Facilitate evidence-based treatment for depression

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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 25, 2005): 300
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2006
• Actual Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

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:

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00137306
• Other Study ID Numbers: SUT 02-211
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
• Study Sponsor: US Department of Veterans Affairs
• Collaborators: Not Provided

Investigators

• Principal Investigator: Geoffrey M. Curran, PhD; Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

• PRS Account: VA Office of Research and Development
• Verification Date: February 2007