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

6. juli 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

507

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Adfærdsmæssigt: 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.
Andre navne:
  • TES
  • Therapeutic Education System
Andet: Treatment-as-Usual (TAU)
Participants randomized to TAU will receive standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program.
Adfærdsmæssigt: 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.
Andre navne:
  • TAU
  • Standard behandling
  • Behandling som sædvanlig

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduced Substance Use and Improved Treatment Retention
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effectiveness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

New York State Psychiatric Institute

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2010

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

14. april 2010

Først indsendt, der opfyldte QC-kriterier

14. april 2010

Først opslået (Skøn)

15. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NYSPI #6051
  • U10DA013035 (U.S. NIH-bevilling/kontrakt)
  • NIDA-CTN-0044 (Anden identifikator: NIDA CTN Protocol Number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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