Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression
Condition: Perinatal Depression, Substance Use
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT)
      in treating women with depression and comorbid substance abuse.
    

Detailed description: 
      Substance use disorder (SUD) and major depressive disorder (MDD) are significant and
      interconnected public health problems facing women, especially perinatal women. Perinatal
      women with co-occurring SUD-MDD are of public health concern because they face numerous
      neonatal and obstetrical risks in addition to the emotional distress, impairment, and adverse
      health effects associated with these disorders. MDD is common in women with SUD, often does
      not remit with SUD treatment, increases the risk of poor SUD treatment outcome, and should be
      treated. Despite the serious morbidity associated with both SUD and MDD in perinatal women
      and despite the consensus among perinatal researchers that there is a need for
      population-specific treatments that address the unique set of challenges associated with this
      period of a women's life, virtually no interventions have been developed or tested to address
      the specific needs of perinatal women with comorbid substance use and depression.
      Furthermore, many tests of existing treatments for SUD-MDD in any population have
      demonstrated limited efficacy for at least one of the two disorders.

      The investigators propose to pilot test a novel 18-20 week group treatment for SUD-MDD, Sober
      Network Interpersonal Psychotherapy(IPT), which focuses on network support strategies for SUD
      (i.e., enhancement of active sober support) within a broader Interpersonal Psychotherapy
      (IPT) framework. IPT is the treatment of choice for MDD in perinatal populations. Sober
      network support is theoretically consistent with IPT and has been identified as an
      empirically supported mechanism of change of many efficacious SUD treatments. Interpersonal
      difficulties not only affect MDD, but are also strong predictors of SUD relapse in women. A
      social/interpersonal approach to SUD-MDD may be highly efficacious for and relevant to the
      needs of perinatal women because specific interpersonal challenges become more salient during
      the perinatal period. Pilot work (supported by Dr. Johnson's NIDA K23), has shown an
      IPT-based treatment to be feasible, acceptable, and efficacious for MDD among women prisoners
      with SUD-MDD, another vulnerable population with multiple needs. Thus, Sober Network IPT
      integrates a validated treatment for perinatal MDD with empirically supported SUD principles,
      using proposed mechanisms that are particularly relevant to the perinatal period and to our
      target population.

      The purposes of this R34 Exploratory Research proposal are to (a) integrate network support
      strategies for SUD into an IPT framework to create Sober Network IPT for perinatal women with
      substance use and MDD (b) to collect preliminary data on its feasibility, acceptability, and
      initial efficacy within a clinical setting in collaboration with community therapists.
      Attempting to obtain a definitive effect size estimate is not an intended outcome of an R34
      given the limited sample sizes typically supportable under this mechanism. The investigators
      will, however, collect preliminary information to explore potential treatment differences and
      likely effect size ranges. Findings from this proposal will lay the groundwork for a larger
      clinical trial.

      The development aims of this R34 proposal are to:

        1. Adapt IPT to Sober Network IPT for perinatal women with substance use and MDD.

        2. Develop, implement, and evaluate a therapist training program and competence and
           adherence scales.

        3. Improve the clarity, content, acceptability, and feasibility of Sober Network IPT using
           information gathered from two focus groups and a small open trial (n = 6) of perinatal
           women with substance use and MDD.

      The pilot study aims of this R34 proposal are to:

        1. Conduct a randomized pilot trial in a sample of 50 women who meet criteria for substance
           use and MDD during pregnancy or within one year postpartum to demonstrate the
           feasibility and acceptability of the proposed recruitment methods and research design,
           of the therapist training methods, and of delivering the Sober Network IPT treatment.

        2. Examine preliminary evidence for the hypotheses that, relative to treatment-as-usual,
           Sober Network IPT will result in:

             -  Fewer heavy drinking/drug using days through the 3 month follow-up (primary).

             -  Reduced depressive symptoms at post-treatment and 3 month follow-up (primary).

             -  Improved sober support and social support (secondary).

        3. Explore the feasibility of using fetal, neonatal and infant outcomes and engagement in
           health prevention activities (such as immunization and well-child visits) as secondary
           outcomes in a subsequent trial.

      As a result of this R34 Exploratory Research Project, the investigators will have adapted IPT
      into Sober Network IPT, a novel treatment approach for perinatal women with substance use and
      MDD, tested its feasibility, acceptability, and initial efficacy with an eye toward
      dissemination (see D2.13), and the investigators will be prepared to test its efficacy in
      future R01 clinical trials. From a longer term perspective, this program of research will
      advance clinical care and research endeavors for perinatal women with substance use and MDD;
      underserved women with clinical concerns that are of great public health significance.
      Furthermore, if Sober Network IPT is found to be efficacious in our vulnerable target
      population, the investigators anticipate that it could hold promise for a more heterogeneous
      substance use and MDD population.
    

Intervention name(s): Sober Network Interpersonal Psychotherapy (IPT); Treatment as Usual
Intervention type(s): Behavioral; Other
Intervention description(s): IPT will be administered in 16 group 90-minute sessions over 18-20 weeks and 3 individual sessions (at the beginning, middle and end of treatment). These sessions will focus on improving your relationships with others, building sober relationships, setting goals, and increasing coping skills.; Women in the treatment as usual condition will either be referred to appropriate treatment in the community or continue their current substance use treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Substance use; perinatal depression; pregnant