Back to resultsTherapy for Undergraduate College Students Who Binge Drink and Are Depressed (TREADS)
Primary Purpose
Depression, Alcohol Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Motivational Interviewing and Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MI + CBT
CBT
Arm Description
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.
Cognitive behavior therapy (CBT)
Outcomes
Primary Outcome Measures
Daily Drinking Questionnaire
A measure assessing how much one drinks in a typical week
Secondary Outcome Measures
Beck Depression Inventory
A measure assessing symptoms of depression
Full Information
NCT ID
NCT01632319
First Posted
June 28, 2012
Last Updated
October 7, 2021
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01632319
Brief Title
Therapy for Undergraduate College Students Who Binge Drink and Are Depressed
Acronym
TREADS
Official Title
Treatment for Excessive Alcohol Use and Depression in Students (TREADS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MI + CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
Cognitive behavior therapy (CBT)
Intervention Type
Behavioral
Intervention Name(s)
Combined Motivational Interviewing and Cognitive Behavioral Therapy
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily Drinking Questionnaire
Description
A measure assessing how much one drinks in a typical week
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
A measure assessing symptoms of depression
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paola Pedrelli, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Therapy for Undergraduate College Students Who Binge Drink and Are Depressed
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