- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01135420
Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background:
Substance use disorders (SUDs) are highly prevalent among veteran psychiatry inpatients. Dual substance use and psychiatric disorders are related to poor outcomes and rehospitalizations, which are quite costly. However, relatively little is known about how to effectively help dually diagnosed psychiatry inpatients. Telephone Monitoring (TM) is effective among SUD patients at increasing SUD continuing care and self-help utilization and improving SUD outcomes. This study will build on these findings and contribute important new clinical knowledge by determining whether TM is similarly effective when adapted for dually diagnosed veteran psychiatry inpatients. It will evaluate the effectiveness of a manual-guided TM intervention.
Objectives:
Primary hypotheses are that patients in the TM condition, compared to patients in usual care (UC), will attend more SUD continuing care sessions and 12-step group meetings, and have better SUD and psychiatric outcomes. Secondary hypotheses are that TM patients will have fewer and delayed rehospitalizations, and their better outcomes will be mediated by SUD outpatient treatment and 12-step group participation.
Methods:
This study will take place at two VAs: Palo Alto (VISN 21) and Ann Arbor (VISN 11). Dually diagnosed patients in psychiatry inpatient treatment will be randomly assigned to UC or TM. Patients in the TM condition will receive an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment if a relapse occurs, and encourage 12-step self-help group participation. Patients will be assessed at baseline, end-of-intervention, and six months and one-year post-intervention for primary and secondary outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and TM groups on course of primary and secondary outcomes over time; Cox regression models will compare groups on time to rehospitalization; and sequential regression analyses will examine whether outcomes associated with TM are mediated by more SUD continuing care and 12-step group participation.
Status:
As of this time, this project is in the follow-up data collection phase.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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California
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Palo Alto, California, Stati Uniti, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Dually diagnosed veteran in VA inpatient psychiatry treatment
Exclusion Criteria:
- Current diagnosis of schizophrenia or schizoaffective disorder
- too psychiatrically unstable or cognitively impaired to understand informed consent and other study procedures
- does not have ongoing telephone access
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Usual Care
Psychiatry inpatient usual care
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All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).
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Sperimentale: Telephone Monitoring
Patients in the TM condition will receive an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge.
The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.
|
Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge.
The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse.
The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Readiness to Attend Substance Use Disorder Continuing Care
Lasso di tempo: 3 months post-intervention
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Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.
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3 months post-intervention
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Christine Timko, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Pubblicazioni e link utili
Pubblicazioni generali
- Timko C, Cronkite RC, McKellar J, Zemore S, Moos RH. Dually diagnosed patients' benefits of mutual-help groups and the role of social anxiety. J Subst Abuse Treat. 2013 Feb;44(2):216-23. doi: 10.1016/j.jsat.2012.05.007. Epub 2012 Jul 3.
- Timko C, Bonn-Miller MO, McKellar JD, Ilgen MA. Detoxification history and two-year outcomes of substance use disorder treatment and mutual-help group participation. Journal of drug issues. 2014 Jan 1; 44(1):4-21.
- Woodhead E, Cowden Hindash A, Timko C. Dual Diagnosis, Mutual-Help Use, and Outcomes: A Naturalistic Follow-Up. Journal of Dual Diagnosis. 2013 May 3; 9(2):158-164.
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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
- IAC 09-055
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 .