跳至主要内容
临床试验/NCT01535352
NCT01535352已完成不适用

Depressed Mothers in Rural Areas: Web-Facilitated Cognitive Behavioral Treatment

Oregon Research Institute4 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
266
试验地点
4
主要终点
PHQ-9

研究概览

简要总结

Low income mothers of young children represent a disadvantaged group who are at exceptional risk for depressive syndromes and who have increasingly limited access to mental health services. The proposed project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral(CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in an recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in the pilot trial will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms.Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.

详细描述

The project is designed to evaluate Mom-Net, an internet-facilitated cognitive-behavioral (CBT) intervention for depression, adapted from Lewinsohn's Coping with Depression Course, and tailored to mothers of young children. Mom-Net, which was developed and piloted in a recently completed NIMH-funded investigation (MH070426), was designed to overcome the substantial barriers to treatment participation that exist for mothers experiencing economic hardship and those in rural communities. Though the pilot trial demonstrated that the program was very effective in reducing depressive symptoms and related difficulties, it was conducted under the 'idealized' conditions typical of initial intervention tests (e.g., computers and internet connections were supplied to all participants; access to the internet was provided by a single browser; coaches who provided weekly phone support were research staff, and initial recruitment and motivational interviews sessions were conducted via home visits to participants). These conditions likely facilitated recruitment and retention of participants, as well as ease and fidelity of treatment delivery. Thus one goal of the current project is to evaluate the intervention under conditions that are closer to those of real-world service providers and recipients. The current project is also intended to provide a more rigorous test of the intervention than did the pilot in a number of ways. Participants in this project will be 300 mothers of 3-5 year old children recruited through Head Start classrooms and prescreened for the presence of elevated depressive symptoms. Subsequent to the pre-intervention assessment, participants will be randomized to either the intervention or facilitated usual care (FUC) condition. The evaluation of the intervention will focus on maternal depressive symptoms, parenting behavior, and child adjustment. Two follow-up assessments (at 12-month and 24-month intervals) will enable us to examine maintenance of effects. Overall, the investigation will contribute to the evidentiary base regarding the dissemination potential of this empirically-supported intervention, adaptations to which have the potential to enable a greater proportion of the population to access and benefit from it.

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 (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Mother of 3-5 year old child(ren)
  • Reside in rural community, as defined by RUCA
  • Meet DSM IV criteria for major or minor depression based on PHQ-9

排除标准

  • Cannot comprehend spoken English
  • Being treated for depression at intake

研究组 & 干预措施

Internet-facilitated CBT

Experimental

Participants in the randomized trial will be 300 mothers of 3-5 year old children recruited through Head Start (HS) classrooms and screened for the presence of major or minor depression. Subsequent to the pre-intervention assessment, participants will be randomized, with an allocation ratio of 1:1, to either the Mom-Net (MN) intervention or facilitated usual care (FUC) condition. Participants in the MN condition will receive the Mom-Net intervention. The Mom-Net program is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Participants in both conditions will receive Booster calls during the follow-up period.

干预措施: Mom-Net (Behavioral)

Coach-facilitated Treatment as Usual

Active Comparator

Participants in the FUC condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period.

干预措施: Coach-facilitated Treatment as Usual (Behavioral)

结局指标

主要结局

PHQ-9

时间窗: 4 months, 16 months, 28 months

Severity of depression

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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