Intrusion SymptomNCT05500105
Remote Delivery of a Visuospatial Intervention to Reduce Traumatic Intrusive Memories After Paediatric Intensive Care
A study testing Simple cognitive task intervention in people with Intrusion Symptom, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
This study aims to examine the feasibility and acceptability of a brief intervention, involving a imagery-competing task, remotely delivered to parents who are currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from intensive care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intrusion Symptom
- What is being tested?
- Simple cognitive task intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2022to 9 Jun 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent of a child who was discharged from PICU or NICU at least one month prior to study recruitment.
- Parent who is currently experiencing persistent intrusive memories (at least a minimum of three intrusive memories in the past week).
- Parent who has access to, and sufficient ability to use an electronic device (smartphone/tablet and/or computer/laptop) for remote delivery.
- Adult aged 18 or older
- Live in the UK or Ireland
Who cannot join
- Parent of a child who was discharged from PICU or NICU less than one month prior to study recruitment.
- Parent who experienced less than three intrusive memories in the past week
- Parent who does not have access to, and ability to, use an electronic device e.g., computer or smartphone.
- Younger than 18 years old
- Does not live in the UK or Ireland
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Delivery of a Visuospatial Intervention, Involving Tetris Computer Game Play, to Reduce Intrusive Memories in Parents After Paediatric Intensive Care Intensive Care: a Feasibility Study
This study aims to examine the feasibility and acceptability of a brief intervention, involving a imagery-competing task, remotely delivered to parents who are currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from intensive care.
Read the detailed description
This is a feasibility study of a brief intervention, involving a visuospatial intervention (i.e. an imagery-competing task), remotely delivered to parents who are currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from the paediatric intensive care unit (PICU) or neonatal intensive care (NICU).
This study seeks to examine the feasibility and acceptability of delivering this brief intervention remotely with parents currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from PICU or NICU. The study aims to estimate recruitment, retention, outcome completion and adherence rates, assess acceptability, and in addition to explore the preliminary effect of the intervention on primary and secondary outcomes. Specifically, this study seeks to answer the following questions:
- How willing are parents, who are currently experiencing persistent intrusive traumatic memories, at least one month following their child's discharge from PICU or NICU, to take part in this brief intervention delivered remotely?
- How willing are parents to remain in the study until completion at follow up?
- How willing are participants to complete all outcome measures?
- How acceptable is this intervention to parents when delivered remotely?
- Having taken part in the study, how willing are these parents to give consent for their child to take part in this intervention?
- Having completed the intervention, how willing are parents to be part of a randomised control group?
- Does this intervention help reduce the number of intrusive memories participants experience, as well as symptoms of anxiety, depression and PTS from baseline to follow-up?
Please note: After approximately six months into recruitment the enrolment target of 20 participants had not been achieved, only 12 participants had consented to take part in the study by this time. After reflecting on the recruitment process it was decided to include parents whose child had either been admitted to paediatric intensive care (PICU) or neonatal intensive care (NICU). The rationale for this was that research evidence demonstrates that admission to either a NICU or a PICU is similarly stressful for parents (Seideman et al., 1997) and many commonalities exist between them, "most notably the similarity of parent and staff experiences and the coexisting medical, psychological and developmental needs of babies and children" (Atkins \& Syed-Sabir, 2022, p.9). Parents who have had a child in intensive care can experience intrusive memories whether that be paediatric or neonatal intensive care. Therefore, in light of this, it seemed worthwhile to see if explicitly seeking to recruit parents whose child had been admitted to PICU or NICU would improve participant enrolment. On 10th March 2023, after receiving approval from the research ethics committee, the study documents were amended (e.g., advert, participant information sheet etc.) to explicitly extend to parents who have had a child in intensive care to include parents whose child has been in either PICU or NICU.
- Conditions
- Intrusion Symptom
- Being tested
- Simple cognitive task intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple cognitive task interventionOther
Session 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions.
Options to engage in self-administered/guided booster sessions per intrusive memory.
| Study group | Role | What they receive |
|---|---|---|
| Simple cognitive task intervention | Experimental | Session 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions.
Options to engage in self-administered/guided booster sessions per intrusive memory. Receives: Other: Simple cognitive task intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed.
Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily for 7 days.
Measured: At baseline for 7 days, After session 1 for 7 days, and 7 days prior to follow-up at one month post intervention.
Secondary outcomes (5)
Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997)
Self-report measure that assesses subjective distress after a traumatic event (with reference to study event[s]) in the last week. Here we include the intrusion subscale (8 items) and the avoidance subscale (8 items). Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscale scores are calculated for the Intrusion or Avoidance items summed (ranging from 0 to 32 each). Higher scores indicate worse outcome.
Measured: Baseline, 1 week follow-up, and 1 month follow-up
Intrusive memory ratings
It is a 9-item a self-report questionnaire which assesses a number of intrusive memories characteristics. It is adapted from an ongoing trial of the intervention in the UK (GAINS study; ClinicalTrials.gov Identifier: NCT04992390)
Measured: 1 week follow-up and 1 month follow-up
Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001)
It is a 9-item self-report measure of depressive symptoms.
Measured: Baseline, 1 week follow-up, and 1 month follow-up
Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006)
It is a 7-item self-report measure of generalised anxiety symptoms.
Measured: Baseline, 1 week follow-up, and 1 month follow-up
Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
It is is a 5-item scale measuring an individual's ability to function in five domains of everyday life; work, home management, social leisure activities, private leisure activities and close relationships.
Measured: Baseline, 1 week follow-up and 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start15 Sep 2022
- Primary completion9 Jun 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusion SymptomStudies 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
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David McCormack, Queen's University, Belfast
- Investigators
- David McCormack, Dr, Principal investigator, The Queen's University of BelfastLalitha Iyadurai, Dr, Principal investigator, University of OxfordEmily Holmes, Professor, Principal investigator, Uppsala University / Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500105
- Sponsor's protocol ID
- EPS 22_57
- Status last verified
- Nov 2023
- First submitted
- 8 Aug 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be made available starting 6 months after publication. An anonymised database of individual participant data, along with a data dictionary, as well as the Clinical Study Report (which will include summarised anonymised participant data), will be shared on the Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Delivery of a Visuospatial Intervention, Involving Tetris Computer Game Play, to Reduce Intrusive Memories in Parents After Paediatric Intensive Care Intensive Care: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05500105
- Acronym / sponsor ID
- EPS 22_57
- Conditions
- Intrusion Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 12 Aug 2022 (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 study aims to examine the feasibility and acceptability of a brief intervention, involving a imagery-competing task, remotely delivered to parents who are currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from intensive care.
Detailed description
This is a feasibility study of a brief intervention, involving a visuospatial intervention (i.e. an imagery-competing task), remotely delivered to parents who are currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from the paediatric intensive care unit (PICU) or neonatal intensive care (NICU).
This study seeks to examine the feasibility and acceptability of delivering this brief intervention remotely with parents currently experiencing persistent intrusive traumatic memories at least one month following their child's discharge from PICU or NICU. The study aims to estimate recruitment, retention, outcome completion and adherence rates, assess acceptability, and in addition to explore the preliminary effect of the intervention on primary and secondary outcomes. Specifically, this study seeks to answer the following questions:
- How willing are parents, who are currently experiencing persistent intrusive traumatic memories, at least one month following their child's discharge from PICU or NICU, to take part in this brief intervention delivered remotely?
- How willing are parents to remain in the study until completion at follow up?
- How willing are participants to complete all outcome measures?
- How acceptable is this intervention to parents when delivered remotely?
- Having taken part in the study, how willing are these parents to give consent for their child to take part in this intervention?
- Having completed the intervention, how willing are parents to be part of a randomised control group?
- Does this intervention help reduce the number of intrusive memories participants experience, as well as symptoms of anxiety, depression and PTS from baseline to follow-up?
Please note: After approximately six months into recruitment the enrolment target of 20 participants had not been achieved, only 12 participants had consented to take part in the study by this time. After reflecting on the recruitment process it was decided to include parents whose child had either been admitted to paediatric intensive care (PICU) or neonatal intensive care (NICU). The rationale for this was that research evidence demonstrates that admission to either a NICU or a PICU is similarly stressful for parents (Seideman et al., 1997) and many commonalities exist between them, "most notably the similarity of parent and staff experiences and the coexisting medical, psychological and developmental needs of babies and children" (Atkins \& Syed-Sabir, 2022, p.9). Parents who have had a child in intensive care can experience intrusive memories whether that be paediatric or neonatal intensive care. Therefore, in light of this, it seemed worthwhile to see if explicitly seeking to recruit parents whose child had been admitted to PICU or NICU would improve participant enrolment. On 10th March 2023, after receiving approval from the research ethics committee, the study documents were amended (e.g., advert, participant information sheet etc.) to explicitly extend to parents who have had a child in intensive care to include parents whose child has been in either PICU or NICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simple cognitive task intervention | Experimental | Other: Simple cognitive task interventionSession 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions. Options to engage in self-administered/guided booster sessions per intrusive memory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parent of a child who was discharged from PICU or NICU at least one month prior to study recruitment.
- Parent who is currently experiencing persistent intrusive memories (at least a minimum of three intrusive memories in the past week).
- Parent who has access to, and sufficient ability to use an electronic device (smartphone/tablet and/or computer/laptop) for remote delivery.
- Adult aged 18 or older
- Live in the UK or Ireland
Key exclusion criteria (5 listed)
- Parent of a child who was discharged from PICU or NICU less than one month prior to study recruitment.
- Parent who experienced less than three intrusive memories in the past week
- Parent who does not have access to, and ability to, use an electronic device e.g., computer or smartphone.
- Younger than 18 years old
- Does not live in the UK or Ireland
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 |
|---|---|---|
| Simple cognitive task interventionSession 1: A memory cue followed by playing the computer game "Tetris" (e.g. on own smartphone) with mental rotation instructions. Options to engage in self-administered/guided booster sessions per intrusive memory. | Other | Simple cognitive task intervention |
Primary outcome
Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed.
Time frame: At baseline for 7 days, After session 1 for 7 days, and 7 days prior to follow-up at one month post intervention.
Number of intrusive memories of traumatic event(s) recorded by participants in a brief diary daily for 7 days.
5 secondary outcomes
Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997)
Time frame: Baseline, 1 week follow-up, and 1 month follow-up
Intrusive memory ratings
Time frame: 1 week follow-up and 1 month follow-up
Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001)
Time frame: Baseline, 1 week follow-up, and 1 month follow-up
Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006)
Time frame: Baseline, 1 week follow-up, and 1 month follow-up
Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
Time frame: Baseline, 1 week follow-up and 1 month follow-up
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 18 Nov 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be made available starting 6 months after publication. An anonymised database of individual participant data, along with a data dictionary, as well as the Clinical Study Report (which will include summarised anonymised participant data), will be shared on the Open Science Framework.
Related trials for Intrusion Symptom
Recruiting
Estradiol and Intrusive Memories
PTSD, Intrusive Memories
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
David McCormack, Dr principal investigator
The Queen's University of Belfast
Lalitha Iyadurai, Dr principal investigator
University of Oxford
Emily Holmes, Professor principal investigator
Uppsala University / Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple cognitive task intervention in people with Intrusion Symptom, run by Queen's University, Belfast 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 5 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 18 Nov 2023. 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. 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 traumatic event(s) - change in number of intrusive memories is being assessed. (time frame: At baseline for 7 days, After session 1 for 7 days, and 7 days prior to follow-up at one month post 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 18 Nov 2023.