Therapy for Undergraduate College Students Who Binge Drink and Are Depressed (TREADS)
Treatment for Excessive Alcohol Use and Depression in Students (TREADS)
調査の概要
状態
詳細な説明
After a screening visit (2 ½ hrs) to confirm eligibility for the study, all participants will receive 8 weekly, 1-hour, individual sessions therapy with a counselor. Participants will be randomly assigned, by chance, like the flip of a coin, to the therapy course they will attend. In one of the therapy courses, students are asked questions about their drinking and receive personalized feedback about it, and are taught coping skills for their depressive symptoms. In the second course, students are also taught coping skills for their depressive symptoms but they may or may not talk about alcohol consumption depending on the students' preference. So, both courses teach the same coping skills for depressive symptoms but include different levels of focus on alcohol.
Participants will also complete 2 follow-up visits, at the end of the 8 sessions and then again 4 weeks after completing treatment. These will involve filling out some questionnaires and completing a few neuropsychological tests (these questionnaires and neuropsychological tests will also be completed during the screening visit).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Currently enrolled in college as an undergraduate student.
- Ages 18-24 years (inclusive).
- Presence of two binge drinking episodes in the past month (defined as consumption of 5 or more drinks in 2 hours for males and 4 for females; NIAAA, 2004).
- BDI-II 12 (12 is often used to indicate the presence of at least mild depressive symptoms) and <30 (indicating severe depression).
Exclusion Criteria:
- Meeting criteria for substance dependence or abuse (any substance) in the past six months (students with alcohol abuse will not be excluded).
- Diagnosis of bulimia, psychosis, or bipolar disorder.
- Having received any psychosocial treatment for depression or substance abuse in the past month.
- Having received CBT for depression and/or alcohol use in the previous 6 months.
- If receiving pharmacological treatment for depression or substance abuse, has not been on a stable dose for at least 4 weeks.
- Discontinued an antidepressant medication less than 1 month ago.
- Meeting criteria for severe depression or posing a serious suicide or homicide risk.
研究計画
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：MI + CBT
Motivational Interviewing (MI) and cognitive behavioral therapy (CBT).
In this course of therapy students are asked questions about their drinking, receive personalized feedback about it and are taught coping skills for their depressive symptoms.
|
8 sessions with study clinician, which focus on depressive symptom treatment and alcohol use Both courses teach coping skills for depression (CBT). However, one course focuses only on treatment for depression whereas the other provides also information tailored to the students' level of drinking and experience with regard to alcohol use. In one course students are asked questions about their drinking, receive personalized feedback about it and are taught coping skills for their depressive symptoms |
|
アクティブコンパレータ：CBT
Cognitive behavior therapy (CBT)
|
Cognitive behavioral therapy is a type of therapy in which students will be taught coping skills for their depressive symptoms but they may or may not talk about alcohol consumption depending on the students' preference.
|
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 |
|---|---|---|
|
Daily Drinking Questionnaire
時間枠：8 weeks
|
A measure assessing how much one drinks in a typical week
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Beck Depression Inventory
時間枠：8 weeks
|
A measure assessing symptoms of depression
|
8 weeks
|
協力者と研究者
捜査官
- 主任研究者：Paola Pedrelli, PhD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。