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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephanie Gamble, University of Rochester
ClinicalTrials.gov Identifier:
NCT00851669
First received: February 25, 2009
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: April 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current Alcohol Dependence and Major Depression

Exclusion Criteria:

  • Bipolar Disorder
  • Psychosis or schizophrenia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851669

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Stephanie A Gamble, Ph.D. University of Rochester
  More Information

No publications provided

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
Study First Received: February 25, 2009
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014