The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health)
Condition: Alcohol Dependence; Depression
MeSH terms: Alcoholism; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Interpersonal Psychotherapy for Co-occurring Alcohol Dependence and Major Depression (IPT-ADMD); Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; alcohol dependence; women; psychotherapy; men