NCT05039853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 9, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

2.3 years

First QC Date

August 23, 2021

Last Update Submit

November 26, 2024

Conditions

Post-traumatic Stress DisorderMiscarriageEctopic PregnancyPregnancy LossTrauma, Psychological

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Number of intrusive memories of early pregnancy loss

    Week 5

  • Character of intrusive memories

    Week 1 and week 5

  • Severity of PTSD symptoms

    1 month and 3 months

  • Frequency and Severity of Functional Impairment

    1 month and 3 months

  • Severity of re-experiencing symptoms cluster

    1 month and 3 months

  • +5 more secondary outcomes

Other Outcomes (6)

  • 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 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 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

  • +3 more other outcomes

Study Arms (2)

A brief cognitive task-based based intervention

EXPERIMENTAL

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 +/- Booster.

Behavioral: Brief cognitive task-based intervention

Placebo activity

PLACEBO COMPARATOR

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

Behavioral: Placebo activity

Interventions

Brief cognitive task-based interventionBEHAVIORAL

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

A brief cognitive task-based based intervention
Placebo activityBEHAVIORAL

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

Placebo activity

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial college healthcare NHS trust

London, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAbortion, SpontaneousPregnancy, EctopicPsychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Tom Bourne

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to whether the activity they are assigned to is the experimental intervention or the placebo activity.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 10, 2021

Study Start

December 9, 2021

Primary Completion

March 21, 2024

Study Completion

June 1, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

GB(1)