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

NCT ID: NCT05039853

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Post-traumatic Stress Disorder Miscarriage Ectopic Pregnancy Pregnancy Loss Trauma, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants will be blinded to whether the activity they are assigned to is the experimental intervention or the placebo activity.

Study Groups

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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 +/- Booster.

Group Type EXPERIMENTAL

Brief cognitive task-based intervention

Intervention Type BEHAVIORAL

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

Placebo activity

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

Group Type PLACEBO_COMPARATOR

Placebo activity

Intervention Type BEHAVIORAL

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

Interventions

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Brief cognitive task-based intervention

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

Intervention Type BEHAVIORAL

Placebo activity

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Bourne

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial college healthcare NHS trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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21HH6557

Identifier Type: -

Identifier Source: org_study_id