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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01632319
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Duration (Months): 54
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Alcohol Abuse	Behavioral: Combined Motivational Interviewing and Cognitive Behavioral Therapy; Behavioral: Cognitive Behavioral Therapy	N/A

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
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Treatment for Excessive Alcohol Use and Depression in Students (TREADS)
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Daily Drinking Questionnaire [8 weeks]

   A measure assessing how much one drinks in a typical week

Secondary Outcome Measures

1. Beck Depression Inventory [8 weeks]

   A measure assessing symptoms of depression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paola Pedrelli, Director of Dual Diagnoses Studies, Depression Clinical and Research Program, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01632319
• Other Study ID Numbers: 2008P001357
• First Posted: Jul 2, 2012
• Last Update Posted: Oct 11, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Alcoholism; Depression

Study Results

No Results Posted as of Oct 11, 2021