tAckling intruSive Traumatic memoRies After chiLdbirth (ASTRAL): A Single-blind Waitlist Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The change in the number of maternal CB-ITM between the 2 weeks pre- and post-intervention
研究概览
简要总结
This single-blind waitlist randomized controlled trial aims to investigate the efficacy of a single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a visuospatial task (the computer game "Tetris"), on childbirth-related intrusive traumatic memories (CB-ITM) and other childbirth-related posttraumatic stress disorder (CB-PTSD) symptoms. Women who report CB-ITM after 6 weeks postpartum can be included in the study. Participants will be randomly allocated to either the immediate treatment (IT) group or to the waitlist (WL) group.
Women in the IT group will first report their CB-ITM in a daily diary during 2 weeks (diary 1). On the 15th day, they will meet a psychologist to receive the single-session behavioral intervention. They will then complete a daily diary during the 2 weeks post-intervention (diary 2) and during the 5th and 6th weeks post-intervention (diary 3).
Women in the WL group will report their CB-ITM continuously during 4 weeks in diary 1 and 2 before receiving the same intervention on the 30th day. They will also complete a last diary during the 2 weeks post-intervention (diary 3).
It is expected that women in the immediate treatment group (IT group) will have fewer CB-ITM in diary 2, in comparison to the WL group, for which we expect no significant change in the number of CB-ITM between diary 1 and 2.
This study will contribute to the development of a single-session behavioral intervention to reduce CB-ITMs and other CB-PTSD symptoms, which would reduce the distress experienced by mothers and may improve the well-being of the whole family.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written consent
- •Gave birth in one of the study centres
- •Gave birth to a live baby
- •Had at least 4 CB-ITM over the past two weeks
- •Childbirth happened at least 6 weeks ago
排除标准
- •Is not fluent enough in French to participate in the assessments
- •Life-threatening illness of mother or infant
- •Has an established intellectual disability or a psychotic illness
- •Takes propranolol medication
- •Alcohol and/or illicit drug abuse
- •Is not able to distinguish ITM linked to other traumatic events from CB-ITM targeted during the intervention
- •Has an ongoing psychological treatment in relation to her childbirth experience
- •Is under 18 years old
- •Being pregnant
- •Perinatal loss of a child born during the index traumatic childbirth
研究组 & 干预措施
Immediate Treatment
Participants in the immediate treatment group will receive the single-session behavioral intervention on day 15.
干预措施: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay (Behavioral)
Waitlist
Participants in the waitlist control group will receive the single-session behavioral intervention on day 30.
干预措施: A single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a Tetris gameplay (Behavioral)
结局指标
主要结局
The change in the number of maternal CB-ITM between the 2 weeks pre- and post-intervention
时间窗: During the 2 weeks pre- and post-intervention
The number of intrusive traumatic memories related to childbirth reported by participants in a diary during the 2 weeks pre- and post-intervention
次要结局
- The intervention acceptability assessed by participants from 30 to 60 days after the intervention(From 30 to 60 days after the intervention)
- The change in the severity of maternal CB-PTSD symptoms between the 2nd week pre- and post-intervention(2nd weeks pre- and post-intervention)
- The change in the number of maternal CB-ITM between the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention(During the 2 weeks pre-intervention, and the 5th and 6th weeks post-intervention)
- The change in the severity of maternal CB-PTSD symptoms between the second week pre-intervention and the 6th week post-intervention(2nd week pre- and 6th week post-intervention)
研究者
Antje Horsch
Associate professor
Centre Hospitalier Universitaire Vaudois