The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health) (MEADOW/Bridge)
Primary Purpose
Alcohol Dependence, Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD)
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring depression, alcohol dependence, women, psychotherapy, men
Eligibility Criteria
Inclusion Criteria:
- Current Alcohol Dependence and Major Depression
Exclusion Criteria:
- Bipolar Disorder
- Psychosis or schizophrenia
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IPT
Treatment as Usual
Arm Description
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.
Outcomes
Primary Outcome Measures
Timeline Follow-back Interview (percentage days abstinent, average drinks per drinking day)
Secondary Outcome Measures
Beck Depression Inventory
Hamilton Rating Scale for Depression
Full Information
NCT ID
NCT00851669
First Posted
February 25, 2009
Last Updated
July 12, 2013
Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00851669
Brief Title
The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health)
Acronym
MEADOW/Bridge
Official Title
Behavioral Treatment for Alcohol Dependent Women With Co-occurring Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Depression
Keywords
depression, alcohol dependence, women, psychotherapy, men
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPT
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Individual psychotherapy following usual care practice in a chemical dependency treatment program.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Individual psychotherapy following usual care practice in a chemical dependency treatment program.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current Alcohol Dependence and Major Depression
Exclusion Criteria:
Bipolar Disorder
Psychosis or schizophrenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie A Gamble, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health)
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