- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00137306
Facilitating the Adoption of Evidence-Based Depression Management in Substance Use Treatment Programs
Translating Depression Guidelines Into Substance Abuse Treatment
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Arkansas
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No. Little Rock, Arkansas, Stati Uniti, 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, Stati Uniti, 70112
- Southeast Louisiana Veterans Health Care System, New Orleans, LA
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Mississippi
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Biloxi, Mississippi, Stati Uniti, 39531
- VA Gulf Coast Veterans Health Care System
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Jackson, Mississippi, Stati Uniti, 39216
- G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma City, OK
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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:
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Braccio 1
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
|---|
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Program: extent, quality of adoption of protocolPatient: scores on-depression, substance use, and functioning scales
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Misure di risultato secondarie
Misura del risultato |
|---|
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Programs: Staff satisfaction with protocol/intervention Patients: medication adherence
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Geoffrey M. Curran, PhD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SUT 02-211
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .