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Completed

NCT Number: NCT01632319

Therapy for Undergraduate College Students Who Binge Drink and Are Depressed

The purpose of this study is to investigate the effectiveness of 2 different therapy courses for undergraduate college students who binge drink and experience depressive symptoms.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined Motivational Interviewing and Cognitive Behavioral Therapy

Behavioral

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

Cognitive behavioral therapy

Behavioral

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.

Primary outcomes

  1. Daily Drinking Questionnaire

    Time frame: 8 weeks

    A measure assessing how much one drinks in a typical week

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 8 weeks

    A measure assessing symptoms of depression

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Treatment for Excessive Alcohol Use and Depression in Students (TREADS)

Acronym: TREADS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2012
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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