Therapy for Undergraduate College Students Who Binge Drink and Are Depressed

NCT ID: NCT01632319

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-11-30

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).

Conditions

Depression; Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Combined Motivational Interviewing and Cognitive Behavioral Therapy

Intervention Type: 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

CBT

Cognitive behavior therapy (CBT)

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paola Pedrelli

Director of Dual Diagnoses Studies, Depression Clinical and Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paola Pedrelli, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2008P001357

Identifier Type: -

Identifier Source: org_study_id