Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression
Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression
This study will evaluate the effectiveness of Sober Network Interpersonal Psychotherapy (IPT)
 in treating women with depression and comorbid substance abuse.
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.
Inclusion Criteria:

 1. pregnant or has delivered in the past year

 2. reports the use of an illegal drug and/or consumption of 4 or more drinks on one
 occasion within the last 6 months; if postpartum, report the use of an illegal drug
 and/or consumption of 4 or more drinks on one occasion or 7 or more drinks in a week
 within the last 6 months; if pregnant, report the use of an illegal drug within the
 last 6 months and/or the consumption of 2 or more drinks in one month while pregnant,
 along with a history of consumption of 4 or more drinks on one occasion or 7 or more
 drinks in a week within 3 months pre-pregnancy

 3. meets DSM-IV criteria of current Major Depressive Disorder (MDD) by Structured
 Clinical Interview for the DSM-IV(SCID) interview;

 4. has a 17-item Hamilton Rating Scale for Depression (HRSD) score > 16, indicating
 moderate to severe depression;

 5. is between 18 and 50 years old; and

 6. is able to speak and read English sufficiently to be able to complete the study
 procedures

 Exclusion Criteria:

 1. meets lifetime criteria for:

 -  bipolar disorder

 -  a primary psychotic disorder

 -  anorexia nervosa

 -  bulimia nervosa

 2. has started an SUD or MDD medication dose within the 8 weeks prior to enrollment

 3. is imminently suicidal