Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
- Conditions
- Pregnancy LossTrauma, PsychologicalEctopic PregnancyPost-traumatic Stress DisorderMiscarriage
- Interventions
- Behavioral: Brief cognitive task-based interventionBehavioral: Placebo activity
- Registration Number
- NCT05039853
- Lead Sponsor
- Imperial College London
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 168
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A brief cognitive task-based based intervention Brief cognitive task-based intervention Participants will engage in a brief cognitive task including: a memory reminder procedure, playing the computer game, Tetris, on a smart-device using mental rotation. Placebo activity Placebo activity Participants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device.
- Primary Outcome Measures
Name Time Method Number of intrusive memories of early pregnancy loss 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 Outcome Measures
Name Time Method Severity of PTSD symptoms 1 month and 3 months Severity of PTSD measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) 1 and 3 months following early pregnancy loss. Score range is 0-80 with a higher score representing more severe symptoms.
Frequency and Severity of Functional Impairment 1 month and 3 months Functional impairment measured using the Work and Social Adjustment Scale (WSAS) measured 1 and 3 months following early pregnancy loss. Scores range from 0-40 with the higher score representing worse impairment.
Number of intrusive memories of early pregnancy loss Week 5 Number of intrusive memories during the fifth week following early pregnancy loss recorded by participants in a brief daily diary(morning, afternoon, evening and night) for 7 days.
Character of intrusive memories Week 1 and week 5 Character of intrusive memories measured using a numeric scale out of 10 (minimum 1 maximum 10) to rate how vivid and how distressing the intrusive memories were during the first and fifth week following early pregnancy loss
Severity of re-experiencing symptoms cluster 1 month and 3 months Severity of re-experiencing symptoms cluster measured using the re-experincing symptom sub-scale of the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) at 1 and 3 month following early pregnancy loss. Minimum score 0 maximum score 20 with the higher score being worse.
Number of women meeting the diagnostic threshold for PTSD diagnosis 1 month and 3 months Number of women meeting the diagnostic threshold for PTSD diagnosis measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) at 1 month and 3 months following early pregnancy loss.
Severity of Anxiety symptoms 1 month and 3 months Severity of anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe
Severity of Depressions Symptoms 1 month and 3 months Severity of depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe.
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 anxiety measured using Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe
Number of women meeting the diagnostic threshold for moderate/severe depression 1 month and 3 months Number of women meeting the diagnostic threshold for moderate/severe depression measured using Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe
Trial Locations
- Locations (1)
Imperial college healthcare NHS trust
🇬🇧London, United Kingdom