Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task (IMPREL)
Primary Purpose
Post-traumatic Stress Disorder, Miscarriage, Ectopic Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief cognitive task-based intervention
Placebo activity
Sponsored by
About this trial
This is an interventional prevention trial for Post-traumatic Stress Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A brief cognitive task-based based intervention
Placebo activity
Arm Description
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.
Participants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
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
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.
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
Severity of Anxiety symptoms
Severity of anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.
Severity of Depressions Symptoms
Severity of depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 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.
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.
Full Information
NCT ID
NCT05039853
First Posted
August 23, 2021
Last Updated
September 1, 2021
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT05039853
Brief Title
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
Acronym
IMPREL
Official Title
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Miscarriage, Ectopic Pregnancy, Pregnancy Loss, Trauma, Psychological
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be blinded to whether the activity they are assigned to is the experimental intervention or the placebo activity.
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A brief cognitive task-based based intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo activity
Arm Type
Placebo Comparator
Arm Description
Participants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device.
Intervention Type
Behavioral
Intervention Name(s)
Brief cognitive task-based intervention
Intervention Description
Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation.
Intervention Type
Behavioral
Intervention Name(s)
Placebo activity
Intervention Description
Listening to a pod-cast on a smart-device for approximately 15 minutes.
Primary Outcome Measure Information:
Title
Number of intrusive memories of early pregnancy loss
Description
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
Secondary Outcome Measure Information:
Title
Number of intrusive memories of early pregnancy loss
Description
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
Title
Character of intrusive memories
Description
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
Time Frame
Week 1 and week 5
Title
Severity of PTSD symptoms
Description
Severity of PTSD measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) 1 and 3 months following early pregnancy loss
Time Frame
1 month and 3 months
Title
Frequency and Severity of Functional Impairment
Description
Functional impairment measured using the Work and Social Adjustment Scale (WSAS) measured 1 and 3 months following early pregnancy loss
Time Frame
1 month and 3 months
Title
Severity of re-experiencing symptoms cluster
Description
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.
Time Frame
1 month and 3 months
Title
Number of women meeting the diagnostic threshold for PTSD diagnosis
Description
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
Time Frame
1 month and 3 months
Title
Severity of Anxiety symptoms
Description
Severity of anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.
Time Frame
1 month and 3 months
Title
Severity of Depressions Symptoms
Description
Severity of depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.
Time Frame
1 month and 3 months
Title
Number of women meeting the diagnostic threshold for moderate/severe anxiety
Description
Number of women meeting the diagnostic threshold for moderate/severe anxiety measured using HADS at 1 and 3 months.
Time Frame
1 month and 3 months
Title
Number of women meeting the diagnostic threshold for moderate/severe depression
Description
Number of women meeting the diagnostic threshold for moderate/severe depression measured using HADS at 1 and 3 months.
Time Frame
1 month and 3 months
Other Pre-specified Outcome Measures:
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Parker, BSc MBBS
Phone
02033135131
Email
nina.parker@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Bourne
Email
t.bourne@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Bourne
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
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