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临床试验/NCT01550913
NCT01550913已完成1 期

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

Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2011年7月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
59
试验地点
2
主要终点
Change from baseline in heavy drinking/drug using days at 3 months

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant or has delivered in the past year
  • 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
  • meets DSM-IV criteria of current Major Depressive Disorder (MDD) by Structured Clinical Interview for the DSM-IV(SCID) interview;
  • has a 17-item Hamilton Rating Scale for Depression (HRSD) score > 16, indicating moderate to severe depression;
  • is between 18 and 50 years old; and
  • is able to speak and read English sufficiently to be able to complete the study procedures

排除标准

  • meets lifetime criteria for:
  • bipolar disorder
  • a primary psychotic disorder
  • anorexia nervosa
  • bulimia nervosa
  • has started an SUD or MDD medication dose within the 8 weeks prior to enrollment
  • is imminently suicidal

结局指标

主要结局

Change from baseline in heavy drinking/drug using days at 3 months

时间窗: up to 3 months post-treatment

Using the Timeline Followback, participants will report their daily use in the time period between each interview (intake, 6 weeks, 12 weeks, 18-20 weeks and 3 months post treatment). The number of heavy drinking/drug using days reported at intake will be compared to the number reported at the followup assessments.

Change from baseline in depressive symptoms at 18-20 weeks

时间窗: baseline and 18-20 weeks

The total score of the Hamilton Rating Scale for Depression from intake will be compared to the total score at the 18-20 week assessment to show a reduction in the depressive symptoms.

Change from baseline in depressive symptoms at 3 months

时间窗: baseline and 3 months post-treatment

The total score of the Hamilton Rating Scale for Depression from intake will be compared to the total score at the 3 month followup assessment to show a reduction in the depressive symptoms.

次要结局

  • Change from baseline in Sober and social support at 3 months(up to 3 months post-treatment)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Caron Zlotnick

Director of Behavioral Medicine Research

Women and Infants Hospital of Rhode Island

研究点 (2)

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