Post-traumatic Stress DisorderIMPRELNCT05039853
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
A study testing Brief cognitive task-based intervention in people with Post-traumatic Stress Disorder and Miscarriage, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder, Miscarriage, Ectopic Pregnancy
- What is being tested?
- Brief cognitive task-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post-traumatic Stress Disorder, Miscarriage, Ectopic Pregnancy, Pregnancy Loss, Trauma, Psychological
- Being tested
- Brief cognitive task-based intervention, Placebo activity
- Medical subject headings
- Stress Disorders, Post-Traumatic, Abortion, Spontaneous, Pregnancy, Ectopic, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief cognitive task-based interventionBehavioural
Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation +/- Boosters
Placebo activityBehavioural
Listening to a pod-cast on a smart-device for approximately 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Placebo activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1
Secondary outcomes (10)
Number of intrusive memories of early pregnancy loss
Number of intrusive memories during the fifth week following early pregnancy loss recorded by participants in a brief daily diary(morning, afternoon, evening and night) for 7 days.
Measured: Week 5
Character of intrusive memories
Character of intrusive memories measured using a numeric scale out of 10 (minimum 1 maximum 10) to rate how vivid and how distressing the intrusive memories were during the first and fifth week following early pregnancy loss
Measured: Week 1 and week 5
Severity of PTSD symptoms
Severity of PTSD measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) 1 and 3 months following early pregnancy loss. Score range is 0-80 with a higher score representing more severe symptoms.
Measured: 1 month and 3 months
Frequency and Severity of Functional Impairment
Functional impairment measured using the Work and Social Adjustment Scale (WSAS) measured 1 and 3 months following early pregnancy loss. Scores range from 0-40 with the higher score representing worse impairment.
Measured: 1 month and 3 months
Severity of re-experiencing symptoms cluster
Severity of re-experiencing symptoms cluster measured using the re-experincing symptom sub-scale of the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) at 1 and 3 month following early pregnancy loss. Minimum score 0 maximum score 20 with the higher score being worse.
Measured: 1 month and 3 months
Number of women meeting the diagnostic threshold for PTSD diagnosis
Number of women meeting the diagnostic threshold for PTSD diagnosis measured using the Post-traumatic stress disorder Checklist for DSM-5 (PCL-5) at 1 month and 3 months following early pregnancy loss.
Measured: 1 month and 3 months
Severity of Anxiety symptoms
Severity of anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe
Measured: 1 month and 3 months
Severity of Depressions Symptoms
Severity of depression measured using the Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe.
Measured: 1 month and 3 months
Number of women meeting the diagnostic threshold for moderate/severe anxiety
Number of women meeting the diagnostic threshold for moderate/severe anxiety measured using Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months.Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe
Measured: 1 month and 3 months
Number of women meeting the diagnostic threshold for moderate/severe depression
Number of women meeting the diagnostic threshold for moderate/severe depression measured using Hospital Anxiety and Depression Scale (HADS) at 1 and 3 months. Score range 0-21 where 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start9 Dec 2021
- Primary completion21 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Bourne, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039853
- Sponsor's protocol ID
- 21HH6557
- Acronym
- IMPREL
- Status last verified
- Nov 2024
- First submitted
- 23 Aug 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
- ClinicalTrials.gov ID
- NCT05039853
- Acronym / sponsor ID
- IMPREL / 21HH6557
- Conditions
- Post-traumatic Stress Disorder, Miscarriage, Ectopic Pregnancy, Pregnancy Loss, Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A brief cognitive task-based based intervention | Experimental | Behavioral: Brief cognitive task-based interventionParticipants 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. |
| Placebo activity | Placebo comparator | Behavioral: Placebo activityParticipants will engage with a placebo activity: listening to a pod-cast for approximately 15 minutes on a smart-device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief cognitive task-based interventionMemory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation +/- Boosters | Behavioural | A brief cognitive task-based based intervention |
| Placebo activityListening to a pod-cast on a smart-device for approximately 15 minutes. | Behavioural | Placebo activity |
Primary outcome
Number of intrusive memories of early pregnancy loss
Time frame: Week 1
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.
10 secondary outcomes
Number of intrusive memories of early pregnancy loss
Time frame: Week 5
Character of intrusive memories
Time frame: Week 1 and week 5
Severity of PTSD symptoms
Time frame: 1 month and 3 months
Frequency and Severity of Functional Impairment
Time frame: 1 month and 3 months
Severity of re-experiencing symptoms cluster
Time frame: 1 month and 3 months
Number of women meeting the diagnostic threshold for PTSD diagnosis
Time frame: 1 month and 3 months
Severity of Anxiety symptoms
Time frame: 1 month and 3 months
Severity of Depressions Symptoms
Time frame: 1 month and 3 months
Number of women meeting the diagnostic threshold for moderate/severe anxiety
Time frame: 1 month and 3 months
Number of women meeting the diagnostic threshold for moderate/severe depression
Time frame: 1 month and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Bourne principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief cognitive task-based intervention in people with Post-traumatic Stress Disorder and Miscarriage, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of intrusive memories of early pregnancy loss (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.