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Web-delivery of Evidence-based, Psychosocial Treatment for Substance Use Disorders (CTN-0044)

6 juli 2017 bijgewerkt door: New York State Psychiatric Institute

NIDA-CTN-0044: Web-delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders Using the Therapeutic Education System (TES)

The main objective of this study is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The principal objective of the planned trial is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA), called the Therapeutic Education System (TES), as part of community-based, outpatient substance abuse treatment. CRA is a cognitive-behavioral intervention which seeks to give patients skills to achieve and maintain abstinence and improve social functioning and is often paired with contingency management, where patients earn rewards contingent upon drug negative urines. CRA is an intensive treatment, generally delivered in individual sessions 2 to 3 times per week. Thus, it is expensive and time-consuming to deliver, to train clinical staff, and to provide supervision to maintain clinical staff skill. However, because CRA is oriented toward knowledge and skills, it lends itself to being delivered by computer, using computer-interactive learning technologies.

Individuals accepted into community-based outpatient treatment for substance use disorders (excluding those receiving opioid pharmacotherapy for opioid dependence) will be eligible to participate. This is a multi-site, controlled trial, using NIDA's Clinical Trials Network platform, at approximately 10 Community Treatment Programs, in which participants (N = approximately 500) will be randomized to receive 12 weeks of either: (1) Treatment-as-Usual (TAU), reflecting standard treatment at the collaborating treatment programs in which participants are enrolled, or (2) a modification of TAU which includes access to the TES. It is hypothesized that access to TES will improve substance use outcome and retention in outpatient treatment.

Computer interactive interventions like TES have the potential to deliver science-based psychosocial treatments with high fidelity and cost-effectiveness while conserving clinician time to focus on monitoring and addressing patients' needs. If found to be effective, TES could substantially advance the substance abuse treatment system by improving quality of care delivered, increasing availability of treatment slots by extending and leveraging the efforts of clinical staff, and projecting treatment to rural and other underserved areas.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

507

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Connecticut
      • Danbury, Connecticut, Verenigde Staten, 06810
        • MCCA: Midwestern CT Council on Alcoholism
    • Florida
      • Orlando, Florida, Verenigde Staten, 32856
        • The Center for Drug Free Living
    • Hawaii
      • Waipahu, Hawaii, Verenigde Staten, 96797
        • Hina Mauka
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46208
        • Midtown Community Mental Health Center
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21214
        • Harbel Prevention and Recovery Center
    • Massachusetts
      • Fall River, Massachusetts, Verenigde Staten, 02720
        • Stanley Street Treatment and Resources (SSTAR)
    • New York
      • West Hempstead, New York, Verenigde Staten, 11552
        • Project Outreach
    • Oregon
      • Eugene, Oregon, Verenigde Staten, 97402
        • Willamette Family, Inc.
    • Texas
      • Dallas, Texas, Verenigde Staten, 75208
        • Homeward Bound
    • Washington
      • Everett, Washington, Verenigde Staten, 98201
        • Evergreen Manor

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Male and female patients, 18 years or older, accepted for outpatient, substance abuse treatment at a participating study site.
  • Self-report any substance use problem (including alcohol, as long as they also report other drug use in addition to alcohol).
  • Self-report recent drug use.
  • Within 30 days of initiating treatment at a collaborating study site.
  • Self-report a planned substance abuse treatment episode of at least 3 months.

Exclusion Criteria:

  • Receiving opioid replacement medication.
  • Plan to move out of the area within the next 3 months.
  • Insufficient ability to provide informed consent.
  • Insufficient ability to use English to participate meaningfully in the consent process, the interventions or research assessments.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Therapeutic Education System (TES)
Participants randomized to this arm will replace approximately 2 hours of Standard Treatment with the Therapeutic Education System (TES) (comprised of a web-based version of the Community Reinforcement Approach and contingency management).
Gedragsmatig: Therapeutic Education System (TES)
Participants will received modified treatment-as-usual plus the computerized psychosocial intervention (Therapeutic Education System), including contingency management. Participants will be asked to use the self-directed TES intervention twice weekly and will be asked to complete 2 modules during each session (for a total of 4 modules per week) during the 12-week intervention. Participants will receive incentives contingent primarily upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules.
Andere namen:
  • TES
  • Therapeutic Education System
Ander: Treatment-as-Usual (TAU)
Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program.
Gedragsmatig: Treatment-as-Usual (TAU)
Participants in this condition will receive TAU, consisting of standard treatment offered at each collaborating CTP and will reflect the model of treatment typically provided to most individuals in outpatient, community-based substance abuse treatment settings in the U.S. These sessions will consist of a combination of group and individual counseling.
Andere namen:
  • TAU
  • Standaard behandeling
  • Behandeling zoals gebruikelijk

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reduced Substance Use and Improved Treatment Retention
Tijdsspanne: 12-week Treatment Phase

Compared to patients assigned to Treatment as Usual (TAU), patients assigned to modified TAU plus the Therapeutic Education System (Modified TAU + TES) will have:

  1. reduced substance use (measured by a combination of self-report confirmed by urine toxicology) and
  2. better retention in treatment at their community-based treatment programs.
12-week Treatment Phase

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness
Tijdsspanne: 12-week treatment phase, 3- and 6-months post treatment
To evaluate the relative effectiveness of TAU vs. modified TAU + TES on several secondary outcome measures, including measures of HIV risk behavior, psychosocial functioning (in areas of criminal activity, health status improvement, psychological status, family/social relationships, and employment, and treatment acceptability (based on participant feedback).
12-week treatment phase, 3- and 6-months post treatment
Sustained outcome
Tijdsspanne: 3- and 6-months post treatment
To evaluate if improved substance use and retention outcomes are maintained 3- and 6-months post-intervention.
3- and 6-months post treatment
Economic Analysis
Tijdsspanne: 12-week treatment phase, 3- and 6-months post treatment
To perform a comprehensive economic analysis of including TES in TAU to inform decisions regarding adoption of this new therapeutic tool (assessing incremental costs per increased abstinence time and quality adjusted life year). The economic analyses are clinically important, as even if the computerized intervention is shown to be effective, it may not be adopted in community-based treatment programs unless it is shown to be cost-effective due to the considerable financial constraints in such treatment settings.
12-week treatment phase, 3- and 6-months post treatment
Coping Skills
Tijdsspanne: 12-week treatment phase, 3- and 6-months post treatment
To examine coping skills acquisition as a treatment process factor that may underlie changes observed during treatment.
12-week treatment phase, 3- and 6-months post treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

New York State Psychiatric Institute

Medewerkers

National Institute on Drug Abuse (NIDA)

Onderzoekers

  • Hoofdonderzoeker: Edward V Nunes, MD, NIDA Clinical Trials Network - Long Island Regional Node

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2010

Primaire voltooiing (Werkelijk)

1 juni 2012

Studie voltooiing (Werkelijk)

1 september 2012

Studieregistratiedata

Eerst ingediend

14 april 2010

Eerst ingediend dat voldeed aan de QC-criteria

14 april 2010

Eerst geplaatst (Schatting)

15 april 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

6 juli 2017

Laatst geverifieerd

1 juli 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NYSPI #6051
  • U10DA013035 (Subsidie/contract van de Amerikaanse NIH)
  • NIDA-CTN-0044 (Andere identificatie: NIDA CTN Protocol Number)

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