跳至主要内容
临床试验/NCT06991166
NCT06991166招募中不适用

OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers

Hackensack Meridian Health1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年9月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
1
主要终点
Post Partum Depression post initial psychotherapy

研究概览

简要总结

Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby.

One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone.

This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Mother of NICU infant
  • Older than age 18
  • English-speaking
  • Gave birth more than 24 hours ago and less than 12 months prior to enrollment
  • Depression as assessed by:
  • Current/Prior diagnosis of Major Depressive Disorder OR EPDS score above 10 OR EPDS score below 10 AND Endorsement of "sometimes" or "often" on item #10 on the EPDS* ("I have had thoughts of harming myself")

排除标准

  • A diagnosis of Substance Dependency or Substance Use
  • Acute suicidal or infanticidal ideation
  • Current psychosis
  • Medical history of cognitive impairment
  • Infant death of current NICU admission
  • Marked non-compliance with intervention (e.g, non-attendance of more than one session during a 4-week intervention or failure to complete study assessments),
  • Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)

研究组 & 干预措施

4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention

Experimental

After the first 4-week of CBT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of IPT intervention.

干预措施: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth (Behavioral)

4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention

Experimental

After the first 4-week of IPT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of CBT intervention.

干预措施: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth (Behavioral)

4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention

Experimental

After the first 4-week of IPT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of CBT intervention.

干预措施: Interpersonal therapy (IPT) psychotherapy group/telehealth (Behavioral)

4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention

Experimental

After the first 4-week of CBT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of IPT intervention.

干预措施: Interpersonal therapy (IPT) psychotherapy group/telehealth (Behavioral)

结局指标

主要结局

Post Partum Depression post initial psychotherapy

时间窗: At 4 weeks

Quantitative assessment of treatment effectiveness in reducing PPD symptoms will be conducted with the Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report scale. Total scores on the EPDS range from 0 to 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. The measures will be administered at the following timepoints: Week 0 Baseline: At study entry prior to starting group psychotherapy in the Outpatient Behavioral Health practice Week 4: After completing the first 4-week intervention of the two-intervention sequence, prior to "crossing over"

次要结局

  • Postpartum Depression after both types of psychotherapy(At 8 weeks)
  • Postpartum Depression at follow up(At 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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