Therapy for Undergraduate College Students Who Binge Drink and Are Depressed

Depression Clinical Trial

— TREADS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632319
• Other study ID #: 2008P001357
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: November 2016

Study information

• Verified date: October 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Depression

Intervention

Behavioral:
• Combined Motivational Interviewing and Cognitive Behavioral Therapy
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
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Drinking Questionnaire	A measure assessing how much one drinks in a typical week	8 weeks
Secondary	Beck Depression Inventory	A measure assessing symptoms of depression	8 weeks