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Mobile Psychosocial Interventions for MMT Clients (MobileMMT)

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (예상)

219

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: 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
실험적: 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
활성 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
treatment retention
기간: 6 months
participants' retention in methadone maintenance treatment (MMT)
6 months
opioid use
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
other substance use
기간: 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
기간: 6 months
participants' coping skills as measured by the Coping Strategies Scale (CSS)
6 months
readiness to change drug use
기간: 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
기간: 6 months
participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)
6 months
HIV risk behavior
기간: 6 months
participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)
6 months
psychiatric and psychosocial functioning
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Michelle Acosta, Ph.D., National Development and Research Institutes (NDRI)
  • 수석 연구원: Lisa A. Marsch, Ph.D., Dartmouth College
  • 연구 책임자: Honoria Guarino, Ph.D., National Development and Research Institutes (NDRI)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 7월 1일

기본 완료 (실제)

2016년 11월 1일

연구 완료 (예상)

2018년 9월 1일

연구 등록 날짜

최초 제출

2012년 6월 29일

QC 기준을 충족하는 최초 제출

2012년 7월 3일

처음 게시됨 (추정)

2012년 7월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 9월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 9월 13일

마지막으로 확인됨

2017년 9월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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