The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health)
MEADOW/Bridge
Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression
2 other identifiers
interventional
91
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2009
Typical duration for phase_2
1 active site
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
First Submitted
Initial submission to the registry
February 25, 2009
CompletedFirst Posted
Study publicly available on registry
February 26, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 16, 2013
July 1, 2013
4.3 years
February 25, 2009
July 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Beck Depression Inventory
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
Baseline, 8 weeks, 16 weeks, 24 weeks, and 32 weeks for women; Baseline, 8 weeks, and 16 weeks for men
Study Arms (2)
IPT
EXPERIMENTALInterpersonal 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
ACTIVE COMPARATORIndividual psychotherapy following usual care practice in a chemical dependency treatment program.
Interventions
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
Individual psychotherapy following usual care practice in a chemical dependency treatment program.
Eligibility Criteria
You may qualify if:
- Current Alcohol Dependence and Major Depression
You may not qualify if:
- Bipolar Disorder
- Psychosis or schizophrenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester Medical Center
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie A Gamble, Ph.D.
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Department of Psychiatry
Study Record Dates
First Submitted
February 25, 2009
First Posted
February 26, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 16, 2013
Record last verified: 2013-07