Clinical trial NCT05039853: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Miscarriage
Ectopic Pregnancy
Pregnancy Loss
Trauma, Psychological
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of intrusive memories of early pregnancy loss
timeFrame: Week 1
Secondary outcomes:
measure: Number of intrusive memories of early pregnancy loss
timeFrame: Week 5
measure: Character of intrusive memories
timeFrame: Week 1 and week 5
measure: Severity of PTSD symptoms
timeFrame: 1 month and 3 months
measure: Frequency and Severity of Functional Impairment
timeFrame: 1 month and 3 months
measure: Severity of re-experiencing symptoms cluster
timeFrame: 1 month and 3 months
measure: Number of women meeting the diagnostic threshold for PTSD diagnosis
timeFrame: 1 month and 3 months
measure: Severity of Anxiety symptoms
timeFrame: 1 month and 3 months
measure: Severity of Depressions Symptoms
timeFrame: 1 month and 3 months
measure: Number of women meeting the diagnostic threshold for moderate/severe anxiety
timeFrame: 1 month and 3 months
measure: Number of women meeting the diagnostic threshold for moderate/severe depression
timeFrame: 1 month and 3 months
Other outcomes:
measure: 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.
timeFrame: Week 1 , week 5, 1 month and 3 months
measure: 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.
timeFrame: 1 month and 3 months
measure: 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.
timeFrame: 1 and 3 months
measure: 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.
timeFrame: 1 and 3 months
measure: 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.
timeFrame: 1 and 3 months
measure: 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.
timeFrame: 1 and 3 months
Locations:
city: London
country: United Kingdom
facility: Imperial college healthcare NHS trust
Study officials:
affiliation: Imperial College London
name: Tom Bourne
role: PRINCIPAL_INVESTIGATOR
References: