Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post-traumatic Stress Disorder
- Sponsor
- Imperial College London
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Number of intrusive memories of early pregnancy loss
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a randomised controlled trial designed to investigate the impact of a brief-cognitive task based intervention on intrusive memories, mental health symptoms and daily functioning, in women following an early pregnancy loss.
Detailed Description
Women who have experienced an early pregnancy loss (miscarriage or ectopic pregnancy) will be randomly allocated to either a brief cognitive intervention or a placebo activity. Participants will be followed up at week 1, 1 month and 3 months following the intervention. It is hypothesised that those allocated to receive the brief cognitive task-based intervention will develop fever intrusive memories, less severe mental health symptoms and better day to day functioning when compared to women allocated to the placebo activity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years and over
- •Diagnosis of early pregnancy loss (EPL) (missed miscarriage, incomplete miscarriage, complete miscarriage, ectopic pregnancy)
- •Fluent in English
- •Access to a smart device (e.g. phone or tablet)
- •Within 72 hours of EPL (including diagnosis of complete miscarriage or completion of treatment for ectopic pregnancy, missed miscarriage or incomplete miscarriage)
Exclusion Criteria
- •Women who, in the opinion of the researcher, are unable to give fully informed consent to the study due to for example learning impairment or language barrier.
- •Women with a viable intrauterine pregnancy
- •Women with a pregnancy loss occurring after 20 weeks gestation
- •History of severe mental illness or substance misuse
Outcomes
Primary Outcomes
Number of intrusive memories of early pregnancy loss
Time Frame: Week 1
Number of intrusive memories during the first week following early pregnancy loss recorded by participants in a brief daily diary(morning, afternoon, evening and night) for 7 days.
Secondary Outcomes
- Number of intrusive memories of early pregnancy loss(Week 5)
- Character of intrusive memories(Week 1 and week 5)
- Severity of PTSD symptoms(1 month and 3 months)
- Frequency and Severity of Functional Impairment(1 month and 3 months)
- Severity of re-experiencing symptoms cluster(1 month and 3 months)
- Number of women meeting the diagnostic threshold for PTSD diagnosis(1 month and 3 months)
- Severity of Anxiety symptoms(1 month and 3 months)
- Severity of Depressions Symptoms(1 month and 3 months)
- Number of women meeting the diagnostic threshold for moderate/severe anxiety(1 month and 3 months)
- Number of women meeting the diagnostic threshold for moderate/severe depression(1 month and 3 months)