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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
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

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

    First Posted
    August 23, 2021
    Last Updated
    September 1, 2021
    Sponsor
    Imperial College London
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    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

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