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

Imperial College London

Status: Completed

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

Treatments: Behavioral: Placebo activity; Behavioral: Brief cognitive task-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05039853

21HH6557

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups, including a placebo group

A brief cognitive task-based based intervention

Experimental group

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 +/- Booster.

Treatment:

Behavioral: Brief cognitive task-based intervention

Placebo activity

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Placebo activity