IMPREL study
Research type
Research Study
Full title
Improving mental health following early pregnancy loss using a brief cognitive task: A randomised controlled study
IRAS ID
291666
Contact name
Tom Bourne
Contact email
Sponsor organisation
Imperial College Joint Research Compliance Office
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Summary of Research
The aim of this study is to investigate an intervention that can help reduce distressing intrusive memories and improve the mental health of women following early pregnancy loss (EPL). EPL pregnancy loss includes miscarriage and ectopic pregnancy which in the UK alone affects approximately 260,000 women each year.1 in 3 women suffer with symptoms of post-traumatic stress disorder (PTSD) 1 month following EPL. Intrusive memories such as flash-backs of a traumatic event are a core feature of a PTSD diagnosis. Intrusive memories may also be driving other symptom clusters of PTSD, anxiety and depression or be distressing in and of themselves.
Experimental and pilot studies have shown that the formation of intrusive memories can be reduced in people who engage with a brief cognitive intervention that includes a memory reminder and 15 minutes playing Tetris, a computer puzzle game, after a traumatic event. We plan to investigate if this intervention is effective following EPL.
This study will recruit woman from the early pregnancy units at Imperial College Healthcare NHS Trust following an ultrasound diagnosis of EPL. Woman who consent to take part will be randomly allocated to a placebo-control group or an intervention group. The placebo-control group will listen to a pre-selected pod-cast on a smart-device for 15 minutes. The intervention group engage in the cognitive task, including 15 minutes of Tetris game play on a smart-device. Both groups will record the number of ‘flash-backs’ they experience each day for one week in a diary during week one and week five, and complete mental health questionnaires at one month and three months following EPL.
If this intervention reduces distressing intrusive memories and subsequently PTSD or other mental health conditions following EPL, it could offer a scalable and cost-effective way to reduce the extent of psychological suffering experienced in this vulnerable group.
Summary of Results
This study investigated whether we could help to reduce distressing intrusive memories of trauma and improve the mental health of women by delivering a new brief intervention shortly following early pregnancy loss (miscarriage and ectopic pregnancy). The study results have shown that intrusive memories could be reduced in women suffering early pregnancy loss who engage with a brief cognitive task (memory reminder and 15 minutes of Tetris computer gameplay using a technique called mental rotation) when compared with a group of women who engaged with a placebo-control task (listening to a pre-selected podcast for 15 minutes). Our results show that group who engaged in the brief cognitive task had 66.7% fewer intrusive memories 5 weeks after early pregnancy loss compared to the group who listened to the pod-cast. Our results also indicate that there could be longer term and wider mental health benefits from the intervention. The group who participated in the brief cognitive task were bothered by repeated, disturbing and unwanted memories of their early pregnancy loss less frequently and severely 3 months after early pregnancy loss than the group who listened to the pod-cast . Additionally, 3 months after early pregnancy loss, those completing the brief cognitive task reported less posttraumatic stress re-experiencing symptoms, less disruption (caused by intrusive memories) to their concentration, work and other areas of life, as well as less severe symptoms of anxiety compared to the those who listened to the pod-cast. The data from our study also indicates a trend towards lower numbers of women who completed the brief cognitive task meeting criteria for a diagnosis of posttraumatic stress disorder, anxiety and depression although this needs to be investigated further in the future with a larger study.REC name
West of Scotland REC 1
REC reference
21/WS/0079
Date of REC Opinion
26 Jul 2021
REC opinion
Further Information Favourable Opinion