Therapy for Undergraduate College Students Who Binge Drink and Are Depressed (TREADS)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Alcohol Abuse
• Intervention / Treatment: Behavioral: Combined Motivational Interviewing and Cognitive Behavioral Therapy; Behavioral: Cognitive Behavioral Therapy

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: CBT; Cognitive behavior therapy (CBT)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Drinking Questionnaire	A measure assessing how much one drinks in a typical week	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	A measure assessing symptoms of depression	8 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Paola Pedrelli, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: June 29, 2012
• First Posted (Estimate): July 2, 2012

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Depression
• Other Study ID Numbers: 2008P001357