Therapy for Undergraduate College Students Who Binge Drink and Are Depressed (TREADS)
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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) |
- Daily Drinking Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]A measure assessing how much one drinks in a typical week
- 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 |
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| Contact: Clair Cassiello, BA | 617-724-3673 | ccassiello@partners.org |
| 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 | |
| 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 Alcoholism Behavioral Symptoms |
Mood Disorders Mental Disorders Alcohol-Related Disorders Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 21, 2013