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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Paola Pedrelli, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01632319
First received: June 28, 2012
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention
Depression
Alcohol Abuse
Behavioral: Combined Motivational Interviewing and Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment for Excessive Alcohol Use and Depression in Students (TREADS)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Daily Drinking Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A measure assessing how much one drinks in a typical week


Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    A measure assessing symptoms of depression


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632319

Contacts
Contact: Clair Cassiello, BA 617-724-3673 ccassiello@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clair Cassiello, BA    617-724-3673    ccassiello@partners.org   
Principal Investigator: Paola Pedrelli, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Paola Pedrelli, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Paola Pedrelli, Director of Dual Diagnoses Studies, Depression Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01632319     History of Changes
Other Study ID Numbers: 2008P001357
Study First Received: June 28, 2012
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014