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

Depression Clinical Trial

— MEADOW/Bridge  

Official title:

Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851669
• Other study ID #: RSRB00023495
• Secondary ID: NIH Grant 1K23AA
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2009
• Last updated: July 12, 2013
• Start date: April 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Current Alcohol Dependence and Major Depression

Exclusion Criteria:

• Bipolar Disorder

• Psychosis or schizophrenia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Depression
• Depressive Disorder

Intervention

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
• Treatment as Usual
Individual psychotherapy following usual care practice in a chemical dependency treatment program.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day)		Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men	No
Secondary	Beck Depression Inventory		Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men	Yes
Secondary	Hamilton Rating Scale for Depression		Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men	Yes