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

Post-traumatic Stress Disorder Clinical Trial

— IMPREL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05039853
• Other study ID #: 21HH6557
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: July 2023

Study information

• Verified date: September 2021
• Source: Imperial College London
• Contact: Nina Parker, BSc MBBS
• Phone: 02033135131
• Email: nina.parker[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: July 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years and over

2. Diagnosis of early pregnancy loss (EPL) (missed miscarriage, incomplete miscarriage, complete miscarriage, ectopic pregnancy)

3. Fluent in English

4. Access to a smart device (e.g. phone or tablet)

5. Within 72 hours of EPL (including diagnosis of complete miscarriage or completion of treatment for ectopic pregnancy, missed miscarriage or incomplete miscarriage)

Exclusion Criteria:

1. 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.

2. Women with a viable intrauterine pregnancy

3. Women with a pregnancy loss occurring after 20 weeks gestation

4. History of severe mental illness or substance misuse

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Ectopic Pregnancy
• Fetal Death
• Miscarriage
• Post-traumatic Stress Disorder
• Pregnancy Loss
• Pregnancy, Ectopic
• Psychological Trauma
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma, Psychological

Intervention

Behavioral:
• Brief cognitive task-based intervention
Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation.
• Placebo activity
Listening to a pod-cast on a smart-device for approximately 15 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Week 1 , week 5, 1 month and 3 months
Other	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.	1 month and 3 months
Other	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.	1 and 3 months
Other	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.	1 and 3 months
Other	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.	1 and 3 months
Other	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.	1 and 3 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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