Depression Treatment for Low Income Substance Users (LET'S ACT)
2017年2月17日 更新者:Stacey Daughters, PhD、University of North Carolina, Chapel Hill
Depression Treatment for Urban Low Income Minority Substance Users
The objective of the current study is to evaluate the effects of a brief, behavioral activation treatment (the Life Enhancement Treatment for Substance Use; LET'S ACT) on long term outcomes of substance use, HIV risk behaviors and mechanisms of treatment response (depressive symptoms, environmental reward, behavioral activation).
調査の概要
詳細な説明
Approximately 22% of substance users suffer from elevated depressive symptoms, which is associated with higher rates of substance abuse treatment dropout, relapse to substance use, and HIV risk behavior.
Few interventions targeting reinforcement principles have been developed to meet the specific needs of treatment seeking substance users.
One approach that may be especially appropriate in this regard is behavioral activation (BA), which aims to increase individuals' engagement in pleasant events, thereby increasing contact with positive reinforcement and decreasing the frequency of aversive events.
BA has been shown to be efficacious in the treatment of depression, and this uncomplicated and straightforward approach may be especially appropriate for the specific needs of an inner city low income substance abusing sample.
Further, BA compliments standard substance abuse treatment in several key practical and theoretical ways as it is more easily adopted by staff in these settings, more time efficient (e.g., fewer and shorter sessions, group format), more easily understood by patients who suffer from cognitive limitations due to low education level and chronic drug use, and can incorporate aspects of sobriety into its treatment components.
In an initial Stage 1 development project, a version of BA, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed and specifically tailored for inner-city low income minority substance users with elevated depressive symptoms.
Results demonstrated that LETS ACT led to a significantly greater reduction in self-reported depressive symptoms and a significant increase in enjoyment and reward value of activities as compared to the TAU control group (Daughters et al., 2008).
While preliminary findings prove promising, many questions remain unanswered and several extensions of this work are necessary, including an assessment of post treatment substance use and HIV risk behavior, a contact-matched control, and a larger sample size to allow for more complex analyses of the mechanisms underlying these outcomes.
Thus, the objective of the present proposal is to follow-up on our previous Stage 1 treatment development efforts and small scale randomized control trial (RCT) with a fully-powered Stage 2 RCT comparing LETS ACT to nondirective therapy (NDT) among a sample of 263 low income depressed substance users currently receiving residential substance abuse treatment in inner-city Washington, DC.
研究の種類
介入
入学 (実際)
263
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
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District of Columbia
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Washington、District of Columbia、アメリカ、20002
- Salvation Army Harbor Light Treatment Center
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Maryland
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College Park、Maryland、アメリカ、20742
- University of Maryland
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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~65年 (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:
- between 18 and 65 years of age
- beginning their last month of residential treatment
Exclusion Criteria:
- limited mental competency [Mini Mental State Examination score < 23]
- psychosis
- the use of psychotropic medication for < 3 months
- the inability to give informed, voluntary, written consent to participate
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:LETS ACT Behavioral Activation Treatment
LETS ACT is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, & Hopko, 2001).
LETS ACT is based on the belief that the best way to improve mood, remain sober, and to make long-term life changes is by changing and increasing one's activity level.
It has been modified to accommodate the needs of a substance using population currently receiving inpatient substance use treatment.
Treatment is provided over a 4-week period and is provided in small group format, with each group consisting of 3-5 patients.
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LETS ACT is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, & Hopko, 2001).
Treatment includes eight sessions over a four-week period and is provided in small group format, with each group consisting of 3-5 patients.
他の名前:
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プラセボコンパレーター:Nondirective Therapy (NDT)
In NDT, the therapist will create an accepting, nonjudgmental, empathic environment to continuously direct client attention to primary feelings, and to facilitate accepting of affective experience using supportive statements, reflective listening, and empathic communications.
Treatment is provided over a 4-week period and is provided in small group format, with each group consisting of 3-5 patients.
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The purpose of Nondirective Therapy (NDT) is to provide group therapy interaction, allowing for the development of a close therapeutic relationship and a safe and accepting environment to facilitate change.
NDT will be conducted as outlined by Crits-Cristoph (1997).
That is, the therapist will create an accepting, nonjudgmental, empathic environment to continuously direct client attention to primary feelings, and to facilitate accepting of affective experience using supportive statements, reflective listening, and empathic communications.
Patients will received NDT in a small group format (3-5 participants) and will meet over the course of 4 weeks.
他の名前:
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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 |
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Substance Use
時間枠:baseline to a 12-month post treatment follow up period
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Urine Screen and Timeline Followback
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baseline to a 12-month post treatment follow up period
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Beck Depression Inventory (BDI-II; Beck et al., 1996)
時間枠:BDI-II will be evaluated from baseline to a 12-month follow up period
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The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
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BDI-II will be evaluated from baseline to a 12-month follow up period
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Behavioral Activation for Depression Scale (BADS)
時間枠:baseline to a 12-month post treatment follow up period
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level of activation and avoidance behaviors
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baseline to a 12-month post treatment follow up period
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Reward Probability Index (RPI)
時間枠:baseline to a 12-month post treatment follow up period
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contact with environmental reward
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baseline to a 12-month post treatment follow up period
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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:Stacey B Daughters, Ph.D.、University of Maryland, College Park
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Daughters SB, Braun AR, Sargeant MN, Reynolds EK, Hopko DR, Blanco C, Lejuez CW. Effectiveness of a brief behavioral treatment for inner-city illicit drug users with elevated depressive symptoms: the life enhancement treatment for substance use (LETS Act!). J Clin Psychiatry. 2008 Jan;69(1):122-9. doi: 10.4088/jcp.v69n0116.
- Reese ED, Conway CC, Anand D, Bauer DJ, Daughters SB. Distress tolerance trajectories following substance use treatment. J Consult Clin Psychol. 2019 Jul;87(7):645-656. doi: 10.1037/ccp0000403. Epub 2019 Apr 22.
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 (実際)
2010年10月1日
一次修了 (実際)
2015年6月1日
研究の完了 (実際)
2015年6月1日
試験登録日
最初に提出
2010年8月24日
QC基準を満たした最初の提出物
2010年8月25日
最初の投稿 (見積もり)
2010年8月26日
学習記録の更新
投稿された最後の更新 (実際)
2017年2月23日
QC基準を満たした最後の更新が送信されました
2017年2月17日
最終確認日
2017年2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。
物質使用障害の臨床試験
LETS ACT Behavioral Activation Treatmentの臨床試験
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University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)完了
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University of Maryland, College ParkUniversity of Maryland, Baltimore; Henry Ford Health System募集物質関連障害 | オピオイド使用障害 | 治療遵守 | オピオイドの使用 | ケアの保持 | オピオイド中毒 | オピオイド投薬支援治療アメリカ
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University of Maryland, College ParkUniversity of Maryland, Baltimore; National Center for Complementary and Integrative Health...完了物質使用 | 物質使用障害 | オピオイド使用障害 | ケアの保持 | メタドン治療 | ピア配信 | オピオイド使用障害(MOUD)の投薬 | 行動活性化アメリカ
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University of North Carolina, Chapel HillWuhan Center for Disease Control and Prevention完了