Randomized Controlled Trial of Digitalized Cognitive Behavioral Therapy With Telephone Coaching for Mothers Suffering From Depression During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- Change in the Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
The main objective of the current research project is to evaluate the effectiveness of the digitalized cognitive behavioral therapy program including telephone coaching for antenatal depressive symptoms. The participants are screened from the general population of pregnant women, as a part of the routine maternity health care check-ups. Mothers with depressive symptoms will be randomized into intervention group receiving guided digitalized treatment program or control group receiving education material about depression in digital form.
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
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •fluent in written and spoken Finnish or Swedish
- •access to computer or mobile phone with internet
- •between 12 and 22 weeks pregnant
- •screening and baseline score on the EPDS ≥10 points
排除标准
- •lifetime history of psychotic disorder (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, psychotic depression)
- •active suicidal ideation
- •severe substance abuse or dependence
- •actively ongoing psychotherapy
- •participates in another intervention study aiming at treating the symptoms of antenatal depression
- •multiple pregnancy
研究组 & 干预措施
Digitalized CBT intervention with phone coaching
Participants receive weekly sessions of internet-based CBT, including telephone coaching
干预措施: Digitalized CBT with phone coaching (Behavioral)
Psychoeducation about depression
Participants receive psychoeducative material about depression in digitalized form.
干预措施: Psychoeducation about depression (Other)
结局指标
主要结局
Change in the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: Baseline and 11 weeks after randomization
EPDS is a ten-item self-report questionnaire originally developed to screen for postpartum depression. The respondents are asked about the symptoms of depression. The total score ranges from 0 to 30.
次要结局
- Social Phobia Inventory (SPIN)(Baseline and 11 weeks after randomization)
- Change in the General Anxiety Disorder 7-item scale (GAD-7)(Baseline and 11 weeks after randomization)
- Change in the Beck Depression Inventory II (BDI-II)(Baseline and 11 weeks after randomization)
- Perceived Stress Scale (PSS)(Baseline and 11 weeks after randomization)
- Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ)(Baseline and 11 weeks after randomization)
研究者
Andre Sourander
Professor, Child Psychiatry
University of Turku