Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task

Conditions
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Post-traumatic Stress Disorder, Miscarriage, Ectopic Pregnancy, Pregnancy Loss, Trauma, Psychological

Intervention / Treatment
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* Behavioral: Brief cognitive task-based intervention
* Behavioral: Placebo activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A brief cognitive task-based based intervention<br>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. | Behavioral: Brief cognitive task-based intervention<br>* Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation.<br>|
| Placebo Comparator: Placebo activity<br>Participants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device. | Behavioral: Placebo activity<br>* Listening to a pod-cast on a smart-device for approximately 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intrusive memories of early pregnancy loss | 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. | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intrusive memories of early pregnancy loss | 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. | Week 5 | 
| Character of intrusive memories | Character of intrusive memories measured using a numeric scale out of 10 to rate how vivid and how distressing the intrusive memories were during the first and fifth week following early pregnancy loss | Week 1 and week 5 | 
| Severity of PTSD symptoms | Severity of PTSD measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) 1 and 3 months following early pregnancy loss | 1 month and 3 months | 
| Frequency and Severity of Functional Impairment | Functional impairment measured using the Work and Social Adjustment Scale (WSAS) measured 1 and 3 months following early pregnancy loss | 1 month and 3 months | 
| Severity of re-experiencing symptoms cluster | Severity of re-experiencing symptoms cluster measured using the re-experincing symptom sub-scale of PCL-5 at 1 and 3 month following early pregnancy loss. | 1 month and 3 months | 
| Number of women meeting the diagnostic threshold for PTSD diagnosis | Number of women meeting the diagnostic threshold for PTSD diagnosis measured using the PCL-5 at 1 month and 3 months following early pregnancy loss | 1 month and 3 months | 
| Severity of Anxiety symptoms | Severity of anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. | 1 month and 3 months | 
| Severity of Depressions Symptoms | Severity of depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. | 1 month and 3 months | 
| Number of women meeting the diagnostic threshold for moderate/severe anxiety | Number of women meeting the diagnostic threshold for moderate/severe anxiety measured using HADS at 1 and 3 months. | 1 month and 3 months | 
| Number of women meeting the diagnostic threshold for moderate/severe depression | Number of women meeting the diagnostic threshold for moderate/severe depression measured using HADS at 1 and 3 months. | 1 month and 3 months |