Clinical trial NCT01550913: Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression
Official title: Sober Network IPT for Perinatal Women With Comorbid Substance Use and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Perinatal Depression, Substance Use
Keywords: Substance use
perinatal depression
pregnant
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-12
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in heavy drinking/drug using days at 3 months
timeFrame: up to 3 months post-treatment
measure: Change from baseline in depressive symptoms at 18-20 weeks
timeFrame: baseline and 18-20 weeks
measure: Change from baseline in depressive symptoms at 3 months
timeFrame: baseline and 3 months post-treatment
Secondary outcomes:
measure: Change from baseline in Sober and social support at 3 months
timeFrame: up to 3 months post-treatment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Caron Zlotnick, PhD
role: PRINCIPAL_INVESTIGATOR
References: