Mobile Psychosocial Interventions for MMT Clients (MobileMMT)
2017年9月13日 更新者: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.
調査の概要
状態
わからない
詳細な説明
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.
研究の種類
介入
入学 (予想される)
219
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
New York
-
Long Island City、New York、アメリカ、11101
- Bridge Plaza Treatment and Rehabilitation Clinic
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の: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
|
実験的: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
|
アクティブコンパレータ: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
treatment retention
時間枠:6 months
|
participants' retention in methadone maintenance treatment (MMT)
|
6 months
|
opioid use
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
other substance use
時間枠: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
時間枠:6 months
|
participants' coping skills as measured by the Coping Strategies Scale (CSS)
|
6 months
|
readiness to change drug use
時間枠: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
時間枠:6 months
|
participants' craving for heroin and/or other opioids, as measured by the Heroin/Opiate Craving Questionnaire (HCQ)
|
6 months
|
HIV risk behavior
時間枠:6 months
|
participants' HIV risk behavior as measured by the High Risk-Taking Behavior Scale (HRBS)
|
6 months
|
psychiatric and psychosocial functioning
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Michelle Acosta, Ph.D.、National Development and Research Institutes (NDRI)
- 主任研究者:Lisa A. Marsch, Ph.D.、Dartmouth College
- スタディディレクター:Honoria Guarino, Ph.D.、National Development and Research Institutes (NDRI)
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年7月1日
一次修了 (実際)
2016年11月1日
研究の完了 (予想される)
2018年9月1日
試験登録日
最初に提出
2012年6月29日
QC基準を満たした最初の提出物
2012年7月3日
最初の投稿 (見積もり)
2012年7月4日
学習記録の更新
投稿された最後の更新 (実際)
2017年9月14日
QC基準を満たした最後の更新が送信されました
2017年9月13日
最終確認日
2017年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
standard treatmentの臨床試験
-
University of Oxford完了
-
Medical University of South CarolinaIcahn School of Medicine at Mount Sinai完了
-
Washington State UniversityNational Institute on Drug Abuse (NIDA)完了
-
Rigshospitalet, DenmarkTestcenter Danmark, Statens Serum Institut; Copenhagen Emergency Medical Services完了
-
Reistone Biopharma Company Limited完了
-
Compedica IncProfessional Education and Research Institute募集