An interventional study of Brief cognitive task-based intervention and Placebo activity in Post-traumatic Stress Disorder, Miscarriage and Ectopic Pregnancy, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Imperial College London · Not applicable, Interventional, and Prevention
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.
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 168 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 +/- Booster.
Behavioral: Brief cognitive task-based intervention
Participants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device.
Behavioral: Placebo activity
Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation +/- Boosters
Listening to a pod-cast on a smart-device for approximately 15 minutes.
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.
Time frame: Week 1
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.
Time frame: Week 5
Character of intrusive memories
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
Time frame: 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. Score range is 0-80 with a higher score representing more severe symptoms.
Time frame: 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. Scores range from 0-40 with the higher score representing worse impairment.
Time frame: 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 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.
Time frame: 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 Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) at 1 month and 3 months following early pregnancy loss.
Time frame: 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. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe
Time frame: 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. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe.
Time frame: 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 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
Time frame: 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 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
Time frame: 1 month and 3 months
The relationship between number of intrusive memories of early pregnancy loss and 1. Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
The relationship between the number of intrusive memories of early pregnancy loss and 1. Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
Time frame: Week 1 , week 5, 1 month and 3 months
The relationship between the severity of PTSD symptoms and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
The relationship between the severity of PTSD symptoms measured at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
Time frame: 1 month and 3 months
The relationship between the number of women who reach PTSD diagnostic thresholds and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
The relationship between the number of women who reach PTSD diagnostic threshold at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
Time frame: 1 and 3 months
The relationship between the severity of functional impairment measured at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
The relationship between the severity of functional impairment measured at 1 and 3 months and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
Time frame: 1 and 3 months
The relationship between the severity of symptoms of anxiety and depression, and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
The relationship between the severity of symptoms of anxiety and depression, and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
Time frame: 1 and 3 months
The relationship between the number of women who meet anxiety or depression diagnostic thresholds and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
The relationship between the number of women who meet diagnostic thresholds for moderate/severe anxiety or depression and 1.Type of early pregnancy loss and management 2. Timing of traumatic event 3. Recurrent early pregnancy loss 4. Ethnicity and 5. Subsequent pregnancy.
Time frame: 1 and 3 months
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →