The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health) (MEADOW/Bridge)

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ClinicalTrials.gov Identifier: NCT00851669

Recruitment Status : Completed

First Posted : February 26, 2009

Last Update Posted : July 16, 2013

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Stephanie Gamble, University of Rochester

Study Description

Brief Summary:

The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression.

Condition or disease	Intervention/treatment	Phase
Alcohol Dependence Depression	Behavioral: Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) Behavioral: Treatment as Usual	Phase 2

Detailed Description:

Co-occurring alcohol dependence and major depression (AD-MD) is a serious and common public health problem, yet one that is largely unaddressed by conventional chemical dependency treatment. Among alcohol dependent patients, co-occurring depression is associated with poorer treatment outcomes, increased risk for relapse, worse long-term social and functional adjustment, and higher probability of dire outcomes such as suicide. Treatment research on AD-MD patients is needed to inform effective practice. This study provides an initial test of the applicability of Interpersonal Psychotherapy for alcohol dependent women with major depression (IPT-ADMD). The goal of the proposed research project is to refine and test a behavioral intervention that addresses women's co-occurring alcohol dependence and depression within a cohesive interpersonal frame. In Phase 1 of the project, IPT-ADMD will be piloted with 15 AD-MD women enrolled in a MICA (mentally-ill chemical abusers) group treatment program. Findings from Phase 1 will be used to refine the treatment, assessment, and therapist training procedures. In Phase 2, a randomized controlled trial with 60 AD-MD women will be conducted 1) to determine IPT-ADMD's feasibility and acceptability as an adjunct to standard MICA group treatment, and 2) to assess the comparative effects of IPT-ADMD to treatment-as-usual individual therapy (TAU-IT). Compared to TAU-IT, IPT-ADMD is hypothesized to lead to greater reductions in women's drinking frequency, drinking intensity, and depressive symptoms, and to improved interpersonal functioning.

In addition to the current intervention study comparing IPT-ADMD with TAU-IT, we are piloting IPT-ADMD with men in a sub-protocol of the main study. The target population of the Bridge Program will be men with alcohol dependence and co-occurring major depression. We hypothesize that IPT will be feasible and acceptable and will improve drinking frequency and intensity; depressive symptoms; and interpersonal functioning. The proposed sub-protocol will allow us to determine if future clinical trials of IPT should include both male and female patients with co-occurring alcohol dependence and depression.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	91 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression
Study Start Date :	April 2009
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Depression

MedlinePlus related topics: Alcoholism and Alcohol Abuse

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: IPT Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of patients with co-occurring alcohol dependence and major depression	Behavioral: Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD) is Interpersonal Psychotherapy with modifications specifically designed for the treatment of patients with co-occurring alcohol dependence and major depression
Active Comparator: Treatment as Usual Individual psychotherapy following usual care practice in a chemical dependency treatment program.	Behavioral: Treatment as Usual Individual psychotherapy following usual care practice in a chemical dependency treatment program.

Outcome Measures

Primary Outcome Measures :

Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day) [ Time Frame: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men ]

Secondary Outcome Measures :

Beck Depression Inventory [ Time Frame: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men ]
Hamilton Rating Scale for Depression [ Time Frame: Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Current Alcohol Dependence and Major Depression

Exclusion Criteria:

Bipolar Disorder
Psychosis or schizophrenia

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851669

Locations


United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators


Principal Investigator:	Stephanie A Gamble, Ph.D.	University of Rochester

More Information


Responsible Party:	Stephanie Gamble, Assistant Professor Department of Psychiatry, University of Rochester
ClinicalTrials.gov Identifier:	NCT00851669 History of Changes
Other Study ID Numbers:	RSRB00023495 NIH Grant 1K23AA017246-01A1
First Posted:	February 26, 2009 Key Record Dates
Last Update Posted:	July 16, 2013
Last Verified:	July 2013

Keywords provided by Stephanie Gamble, University of Rochester:


depression alcohol dependence women psychotherapy men

Additional relevant MeSH terms:


Depression Depressive Disorder Alcoholism Behavioral Symptoms Mood Disorders Mental Disorders Alcohol-Related Disorders	Substance-Related Disorders Chemically-Induced Disorders Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs

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