Therapy for Undergraduate College Students Who Binge Drink and Are Depressed
TREADS
Treatment for Excessive Alcohol Use and Depression in Students (TREADS)
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started May 2012
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedOctober 11, 2021
October 1, 2021
4.5 years
June 28, 2012
October 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Daily Drinking Questionnaire
A measure assessing how much one drinks in a typical week
8 weeks
Secondary Outcomes (1)
Beck Depression Inventory
8 weeks
Study Arms (2)
MI + CBT
EXPERIMENTALMotivational 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.
CBT
ACTIVE COMPARATORCognitive behavior therapy (CBT)
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paola Pedrelli, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Dual Diagnoses Studies, Depression Clinical and Research Program
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 2, 2012
Study Start
May 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
October 11, 2021
Record last verified: 2021-10