Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression

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