Clinical trial NCT01632319: Therapy for Undergraduate College Students Who Binge Drink and Are Depressed
Official title: Treatment for Excessive Alcohol Use and Depression in Students (TREADS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Alcohol Abuse
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-07-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Daily Drinking Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Paola Pedrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: