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

Sponsor
Imperial College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05039853
Collaborator
(none)
146
2
21

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief cognitive task-based intervention
  • Behavioral: Placebo activity
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants will be blinded to whether the activity they are assigned to is the experimental intervention or the placebo activity.
Primary Purpose:
Prevention
Official Title:
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: A brief cognitive task-based based intervention

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.

Behavioral: Brief cognitive task-based intervention
Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation.

Placebo Comparator: Placebo activity

Participants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device.

Behavioral: Placebo activity
Listening to a pod-cast on a smart-device for approximately 15 minutes.

Outcome Measures

Primary Outcome Measures

  1. Number of intrusive memories of early pregnancy loss [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 Outcome Measures

  1. Number of intrusive memories of early pregnancy loss [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 [Week 1 and week 5]

    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

  3. Severity of PTSD symptoms [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

  4. Frequency and Severity of Functional Impairment [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

  5. Severity of re-experiencing symptoms cluster [1 month and 3 months]

    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.

  6. Number of women meeting the diagnostic threshold for PTSD diagnosis [1 month and 3 months]

    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

  7. Severity of Anxiety symptoms [1 month and 3 months]

    Severity of anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.

  8. Severity of Depressions Symptoms [1 month and 3 months]

    Severity of depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.

  9. Number of women meeting the diagnostic threshold for moderate/severe anxiety [1 month and 3 months]

    Number of women meeting the diagnostic threshold for moderate/severe anxiety measured using HADS at 1 and 3 months.

  10. Number of women meeting the diagnostic threshold for moderate/severe depression [1 month and 3 months]

    Number of women meeting the diagnostic threshold for moderate/severe depression measured using HADS at 1 and 3 months.

Other Outcome Measures

  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. [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. [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. [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. [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. [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imperial College London

Investigators

  • Principal Investigator: Tom Bourne, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05039853
Other Study ID Numbers:
  • 21HH6557
First Posted:
Sep 10, 2021
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021