NCT01632319

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

4.5 years

First QC Date

June 28, 2012

Last Update Submit

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

EXPERIMENTAL

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

CBT

ACTIVE COMPARATOR

Cognitive behavior therapy (CBT)

Behavioral: Cognitive Behavioral Therapy

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

MI + CBT

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.

CBT

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

DepressionAlcoholism

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Paola Pedrelli, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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

Locations