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Clinical Trials/NCT01632319
NCT01632319CompletedNot Applicable

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

Massachusetts General Hospital2 sites in 1 country96 target enrollmentStarted: May 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
96
Locations
2
Primary Endpoint
Daily Drinking Questionnaire

Study Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 24 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Daily Drinking Questionnaire

Time Frame: 8 weeks

A measure assessing how much one drinks in a typical week

Secondary Outcomes

  • Beck Depression Inventory(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paola Pedrelli

Director of Dual Diagnoses Studies, Depression Clinical and Research Program

Massachusetts General Hospital

Study Sites (2)

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