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Completed

NCT Number: NCT05039853

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Abortion, Spontaneous Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Mental Disorders Miscarriage Pregnancy Complications Pregnancy Loss Pregnancy, Ectopic Psychological Trauma Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Imperial college healthcare NHS trust

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief cognitive task-based intervention

Behavioral

Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation +/- Boosters

Placebo activity

Behavioral

Listening to a pod-cast on a smart-device for approximately 15 minutes.

Primary outcomes

  1. Number of intrusive memories of early pregnancy loss

    Time frame: Week 1

    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 outcomes

  1. Number of intrusive memories of early pregnancy loss

    Time frame: Week 5

    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.

  2. Character of intrusive memories

    Time frame: Week 1 and week 5

    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

  3. Severity of PTSD symptoms

    Time frame: 1 month and 3 months

    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.

  4. Frequency and Severity of Functional Impairment

    Time frame: 1 month and 3 months

    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.

  5. Severity of re-experiencing symptoms cluster

    Time frame: 1 month and 3 months

    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.

  6. Number of women meeting the diagnostic threshold for PTSD diagnosis

    Time frame: 1 month and 3 months

    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.

  7. Severity of Anxiety symptoms

    Time frame: 1 month and 3 months

    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

  8. Severity of Depressions Symptoms

    Time frame: 1 month and 3 months

    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.

  9. Number of women meeting the diagnostic threshold for moderate/severe anxiety

    Time frame: 1 month and 3 months

    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

  10. Number of women meeting the diagnostic threshold for moderate/severe depression

    Time frame: 1 month and 3 months

    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

Other outcomes

  1. 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.

    Time frame: Week 1 , week 5, 1 month and 3 months

    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.

  2. 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.

    Time frame: 1 month and 3 months

    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.

  3. 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.

    Time frame: 1 and 3 months

    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.

  4. 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 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.

  5. 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 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.

  6. 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.

    Time frame: 1 and 3 months

    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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: IMPREL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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