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

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Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Number of intrusive memories of early pregnancy loss

Secondary Outcome

 Number of intrusive memories of early pregnancy loss

Condition

Post-traumatic Stress Disorder

Intervention

Brief cognitive task-based intervention

Study Arms / Comparison Groups

 A brief cognitive task-based based intervention
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

146

Start Date

October 2021

Completion Date

July 2023

Primary Completion Date

April 2023

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Tom Bourne, 02033135131, [email protected]



Administrative Informations


NCT ID

NCT05039853

Organization ID

21HH6557


Responsible Party

Sponsor

Study Sponsor

Imperial College London


Study Sponsor

Tom Bourne, Principal Investigator, Imperial College London


Verification Date

September 2021