Posttraumatic Stress DisorderNCT04286724
Tackling Intrusive Traumatic Memories After a Difficult Birth
A study testing Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris") in people with Posttraumatic Stress Disorder and Intrusive Traumatic Memories, run by Antje Horsch at 1 site in Switzerland.
Trial summary
This proof-of-principle study aims to investigate the effects of a brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth, on birth-related intrusive traumatic memories and other postpartum posttraumatic… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder, Intrusive Traumatic Memories
- What is being tested?
- Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Jul 2020to 14 Apr 2021
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gave birth at the Lausanne University Hospital
- Gave written consent
- Have at least 4 related-to-childbirth intrusions over the two weeks prior to recruitment, and at least 2 related-to-childbirth intrusions during the pre-intervention diary
- Gave birth more than 6 weeks ago
- Is able to distinguish intrusions linked to the traumatic childbirth from intrusions linked to other traumatic events
Who cannot join
- Gave birth to a stillborn child
- Not fluent in French
- Severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
- Have an established intellectual disability, or psychiatric history such as psychotic illness
- Alcohol abuse and/or illegal drug use
- Currently receiving psychological care in relation with the traumatic birth experience
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Tackling Intrusive Traumatic Memories After a Difficult Birth: a proof-of Principle Study
This proof-of-principle study aims to investigate the effects of a brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth, on birth-related intrusive traumatic memories and other postpartum posttraumatic stress symptoms. Women who report birth-related intrusive memories after 6 weeks postpartum will monitor their intrusive traumatic memories in a daily diary. After two weeks of diary, they will meet a psychologist to briefly evoke the memory of their birth, and receive a brief behavioural procedure including playing Tetris. Participants will then continue to complete an intrusive traumatic memory diary during two weeks. It is predicted that they will report fewer intrusive memories in the two weeks following the intervention, compared to the two weeks before. This will inform the potential future development of a simple computerized intervention procedure to reduce distressing psychological symptoms after traumatic childbirth.
- Being tested
- Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")Behavioural
Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of intrusive memories of the index trauma
Frequency of intrusive traumatic memories related to childbirth recorded by participants in a trauma-related intrusive memories diary over the two weeks after the intervention
Measured: Within 2 weeks following the intervention
Secondary outcomes (3)
Presence and severity of maternal PTSD symptoms
PTSD Checklist (PCL-5) for DSM-5
Measured: 1 month after the intervention
Frequency of intrusive memories of the index trauma
Frequency of intrusive traumatic memories related to childbirth recorded by participants in a trauma-related intrusive memories diary between the 4th and 6th weeks following the intervention
Measured: Between 4 and 6 weeks after the intervention
Psychological distress related to intrusive memories of the index trauma
Rating scale for psychological distress related to intrusive memories related to childbirth that are reported in an intrusive memories diary over the two weeks after the intervention. It is a SUDS (Subjective Units of Distress Scale) from 1 to 10 (1= No distress at all while having the intrusion ; 10 = Extreme distress while having the intrusion).
Measured: Within 2 weeks following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start8 Jul 2020
- Primary completion15 Mar 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pre-post study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antje Horsch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antje Horsch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Antje Horsch, PhD, Principal investigator, University of Lausanne and Lausanne University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286724
- Sponsor's protocol ID
- 2019-01435
- Other IDs
- 2019
- Status last verified
- Jun 2021
- First submitted
- 25 Feb 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tackling Intrusive Traumatic Memories After a Difficult Birth: a proof-of Principle Study
- ClinicalTrials.gov ID
- NCT04286724
- Acronym / sponsor ID
- 2019-01435
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Antje HorschUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 27 Feb 2020 (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 proof-of-principle study aims to investigate the effects of a brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth, on birth-related intrusive traumatic memories and other postpartum posttraumatic stress symptoms. Women who report birth-related intrusive memories after 6 weeks postpartum will monitor their intrusive traumatic memories in a daily diary. After two weeks of diary, they will meet a psychologist to briefly evoke the memory of their birth, and receive a brief behavioural procedure including playing Tetris. Participants will then continue to complete an intrusive traumatic memory diary during two weeks. It is predicted that they will report fewer intrusive memories in the two weeks following the intervention, compared to the two weeks before. This will inform the potential future development of a simple computerized intervention procedure to reduce distressing psychological symptoms after traumatic childbirth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pre-post study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris") |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gave birth at the Lausanne University Hospital
- Gave written consent
- Have at least 4 related-to-childbirth intrusions over the two weeks prior to recruitment, and at least 2 related-to-childbirth intrusions during the pre-intervention diary
- Gave birth more than 6 weeks ago
- Is able to distinguish intrusions linked to the traumatic childbirth from intrusions linked to other traumatic events
Key exclusion criteria (6 listed)
- Gave birth to a stillborn child
- Not fluent in French
- Severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations)
- Have an established intellectual disability, or psychiatric history such as psychotic illness
- Alcohol abuse and/or illegal drug use
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 behavioural procedure including a computerized visuospatial task (computer game "Tetris")Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth | Behavioural | Intervention |
Primary outcome
Frequency of intrusive memories of the index trauma
Time frame: Within 2 weeks following the intervention
Frequency of intrusive traumatic memories related to childbirth recorded by participants in a trauma-related intrusive memories diary over the two weeks after the intervention
3 secondary outcomes
Presence and severity of maternal PTSD symptoms
Time frame: 1 month after the intervention
Frequency of intrusive memories of the index trauma
Time frame: Between 4 and 6 weeks after the intervention
Psychological distress related to intrusive memories of the index trauma
Time frame: Within 2 weeks following the intervention
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 22 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Antje Horsch, PhD principal investigator
University of Lausanne and Lausanne University Hospital
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 behavioural procedure including a computerized visuospatial task (computer game "Tetris") in people with Posttraumatic Stress Disorder and Intrusive Traumatic Memories, run by Antje Horsch at 1 site in Switzerland.
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 6 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 22 Jun 2021. 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 Switzerland. 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. 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?
Frequency of intrusive memories of the index trauma (time frame: Within 2 weeks following the intervention). 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 22 Jun 2021.