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Remote Delivery of a Visuospatial Intervention to Reduce Traumatic Intrusive Memories After PICU

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ClinicalTrials.gov Identifier: NCT05500105
Recruitment Status : Recruiting
First Posted : August 12, 2022
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
David McCormack, Queen's University, Belfast

Brief 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 PICU.

Condition or disease Intervention/treatment Phase
Intrusion Symptom Other: Simple cognitive task intervention Not Applicable

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).

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. 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:

  1. How willing are parents, who are currently experiencing persistent intrusive traumatic memories, at least one month following their child's discharge from PICU, to take part in this brief intervention delivered remotely?
  2. How willing are parents to remain in the study until completion at follow up?
  3. How willing are participants to complete all outcome measures?
  4. How acceptable is this intervention to parents when delivered remotely?
  5. Having taken part in the study, how willing are these parents to give consent for their child to take part in this intervention?
  6. Having completed the intervention, how willing are parents to be part of a randomised control group?
  7. 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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Delivery of a Visuospatial Intervention, Involving Tetris Computer Game Play, to Reduce Intrusive Memories in Parents After Paediatric Intensive Care: a Feasibility Study
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : February 13, 2023
Estimated Study Completion Date : March 27, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Simple cognitive task intervention

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.

Other: Simple cognitive task intervention

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997) [ Time Frame: Baseline, 1 week follow-up, and 1 month follow-up ]
    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.

  2. Intrusive memory ratings [ Time Frame: 1 week follow-up and 1 month follow-up ]
    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)

  3. Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001) [ Time Frame: Baseline, 1 week follow-up, and 1 month follow-up ]
    It is a 9-item self-report measure of depressive symptoms.

  4. Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006) [ Time Frame: Baseline, 1 week follow-up, and 1 month follow-up ]
    It is a 7-item self-report measure of generalised anxiety symptoms.

  5. Work and Social Adjustment Scale (WSAS; Mundt et al., 2002) [ Time Frame: Baseline, 1 week follow-up and 1 month follow-up ]
    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.


Other Outcome Measures:
  1. Self-administered use of the intervention [ Time Frame: 1 week follow-up and 1 month follow-up ]
    It is a self-report measure containing 4 items which will be used to assess adherence to self-administered 'booster' sessions of the intervention. It is adapted from ongoing trial of the intervention in Sweden (EKUT-P study; ClinicalTrials.gov Identifier: NCT04460014)

  2. Interview with participants regarding participation [ Time Frame: 1 month follow-up ]
    A semi-structured interview regarding their experience of taking part in the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Parent of a child who was discharged from PICU at least one month prior to study recruitment.
  2. Parent who is currently experiencing persistent intrusive memories (at least a minimum of three intrusive memories in the past week).
  3. Parent who has access to, and sufficient ability to use an electronic device (smartphone/tablet and/or computer/laptop) for remote delivery.
  4. Adult aged 18 or older
  5. Live in the UK or Ireland

Exclusion Criteria:

  1. Parent of a child who was discharged from PICU less than one month prior to study recruitment.
  2. Parent who experienced less than three intrusive memories in the past week
  3. Parent who does not have access to, and ability to, use an electronic device e.g., computer or smartphone.
  4. Younger than 18 years old
  5. Does not live in the UK or Ireland

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500105


Contacts
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Contact: Sinead Farquharson +44 (0)28 9097 4283 sfarquharson02@qub.ac.uk
Contact: David McCormack +44 (0)28 9097 4283 d.mccormack@qub.ac.uk

Locations
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United Kingdom
Queen's University Belfast Recruiting
Belfast, United Kingdom, BT7 1PT
Contact: David McCormack    +44 (0)28 9097 4283    d.mccormack@qub.ac.uk   
Sponsors and Collaborators
Queen's University, Belfast
Investigators
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Principal Investigator: David McCormack, Dr The Queen's University of Belfast
Principal Investigator: Lalitha Iyadurai, Dr University of Oxford
Principal Investigator: Emily Holmes, Professor Uppsala University / Karolinska Institutet
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Responsible Party: David McCormack, Clinical Director, Doctorate in Clinical Psychology Programme, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT05500105    
Other Study ID Numbers: EPS 22_57
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Starting 6 months after publication of a paper.
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No