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Mobile Psychosocial Interventions for MMT Clients (MobileMMT)

13. September 2017 aktualisiert von: National Development and Research Institutes, Inc.

Providing Psychosocial Interventions to Substance Abusers Via Mobile Technology

This study will develop and evaluate the preliminary efficacy and cost-effectiveness of a mobile phone-delivered psychosocial intervention for opioid-dependent adults (N=219) in methadone maintenance treatment (MMT). A three-arm, randomized clinical trial will evaluate the relative efficacy of: (1) standard MMT; (2) standard MMT plus the mobile intervention; and (3) a mobile-based control condition on the primary outcomes of treatment retention and opioid use (assessed via urine toxicology). If results are promising, this novel therapeutic tool may have a tremendous impact on improving access to and effectiveness of substance abuse treatment in a variety of other populations (and could also be adapted for an array of other behavioral health applications), while significantly limiting costs.

Studienübersicht

Detaillierte Beschreibung

This study will develop and implement a mobile technology-delivered psychosocial intervention for opioid-dependent adults in methadone maintenance treatment (MMT). This novel therapeutic system promises to be cost-effective and to enable the provision of flexible, on-demand therapeutic support outside of the formal treatment setting. The specific aims of this investigation are as follows: Aim 1: The investigators will develop a novel, interactive, evidence-based psychosocial intervention delivered via mobile phones, designed to promote skills acquisition and reduce illicit drug use. Specifically, our Mobile Therapeutic System (MTS) will offer key elements of a psychosocial intervention for substance use disorders of known efficacy (the Community Reinforcement Approach). Participants will be provided with unlimited daily prompts to encourage use of the program and will be able to access the application at any time and as much as they choose, within their natural environments. Our iterative development process will include input from focus groups with clients in methadone treatment (n=24), input from experts in the field, and feedback testing of a beta-version of the mobile phone-based program with clients in methadone treatment (n=30). Aim 2: The investigators will evaluate the efficacy of this mobile tool with participants entering MMT during the first three months of their treatment (n=219). The investigators will evaluate the relative preliminary efficacy of (1) standard treatment, (2) standard treatment plus MTS and (3) a mobile-based control condition on the primary outcomes of retention and opioid use (via urine toxicology) and secondary outcomes of other substance use (via urine toxicology and self-report), readiness to change drug use behavior, coping skills, opioid craving, HIV risk behavior, and psychosocial functioning during the 3-month intervention phase. Durability of effects will be examined at 1 and 3 month follow-ups. Aim 3: The investigators will perform an economic analysis of MTS in community-based MMT. The investigators will estimate the incremental costs and the incremental cost-effectiveness ratio (ICER) of MTS relative to standard care and the mobile control group. The primary ICER will be the incremental costs per increased abstinence time (the clinical measure of effectiveness) and the secondary ICER will be incremental costs per increased quality adjusted life year (QALY) (the economic measure of effectiveness). Cost data will be vital to future translational projects to disseminate effective mobile interventions in community systems. If results are promising, this novel therapeutic tool may have a tremendous impact on improving access to and effectiveness of substance abuse treatment in a variety of other populations (and could also be adapted for an array of other behavioral health applications), while significantly limiting costs.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

219

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • New York
      • Long Island City, New York, Vereinigte Staaten, 11101
        • Bridge Plaza Treatment and Rehabilitation Clinic

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • client enrolled in the study site's methadone maintenance program
  • within the first month of initiating methadone maintenance treatment
  • 18 years of age or older
  • sufficient English-language ability to participate in informed consent process, complete study assessments and understand the text in mobile phone- delivered interventions

Exclusion Criteria:

  • entering treatment at the study site with the intention of receiving a methadone-assisted withdrawal only
  • evidence of an active psychiatric disorder requiring immediate intervention (e.g., suicidality, psychosis)
  • evidence of significant mental illness that may preclude participation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: standard treatment
the standard drug counseling offered to patients in methadone maintenance treatment at the study site
the standard drug counseling offered to patients at the study site's methadone maintenance program
Experimental: Mobile Therapeutic System (MTS)
The Mobile Therapeutic System (MTS) is a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment
the standard drug counseling offered to patients at the study site's methadone maintenance program
a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment
Aktiver Komparator: mobile control
a mobile phone-based application that directs participants to the NIDA website's home page
the standard drug counseling offered to patients at the study site's methadone maintenance program
a mobile phone-based application that directs participants to the NIDA website's homepage

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
treatment retention
Zeitfenster: 6 months
participants' retention in methadone maintenance treatment (MMT)
6 months
opioid use
Zeitfenster: 6 months
participants' illicit use of opioids, as measured by urine toxicology and self-report (self-report data collected via the timeline follow-back calendar assessment [TLFB])
6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
other substance use
Zeitfenster: 6 months
participants' use of alcohol and drugs, as measured by urine toxicology and self-report (self-report data collected via the timeline follow-back calendar assessment [TLFB])
6 months
coping skills
Zeitfenster: 6 months
participants' coping skills as measured by the Coping Strategies Scale (CSS)
6 months
readiness to change drug use
Zeitfenster: 6 months
participants' readiness to change drug use, as measured by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
6 months
heroin/opioid craving
Zeitfenster: 6 months
participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)
6 months
HIV risk behavior
Zeitfenster: 6 months
participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)
6 months
psychiatric and psychosocial functioning
Zeitfenster: 6 months
participants' level of psychiatric functioning (as assessed by the Brief Symptom Inventory [BSI]) and psychosocial functioning (as assessed by the Addiction Severity Index [ASI])
6 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Michelle Acosta, Ph.D., National Development and Research Institutes (NDRI)
  • Hauptermittler: Lisa A. Marsch, Ph.D., Dartmouth College
  • Studienleiter: Honoria Guarino, Ph.D., National Development and Research Institutes (NDRI)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2013

Primärer Abschluss (Tatsächlich)

1. November 2016

Studienabschluss (Voraussichtlich)

1. September 2018

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juli 2012

Zuerst gepostet (Schätzen)

4. Juli 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. September 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. September 2017

Zuletzt verifiziert

1. September 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

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