Remote Delivery of a Visuospatial Intervention to Reduce Traumatic Intrusive Memories After PICU
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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:
-
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?
-
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?
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Number of intrusive memories of traumatic event(s) - change in number of intrusive memories is being assessed. [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
- Impact of Events Scale-Revised (IES-R; Weiss and Marmar, 1997) [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.
- Intrusive memory ratings [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)
- Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001) [Baseline, 1 week follow-up, and 1 month follow-up]
It is a 9-item self-report measure of depressive symptoms.
- Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006) [Baseline, 1 week follow-up, and 1 month follow-up]
It is a 7-item self-report measure of generalised anxiety symptoms.
- Work and Social Adjustment Scale (WSAS; Mundt et al., 2002) [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
- Self-administered use of the intervention [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)
- Interview with participants regarding participation [1 month follow-up]
A semi-structured interview regarding their experience of taking part in the study.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Parent of a child who was discharged from PICU 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
Exclusion Criteria:
-
Parent of a child who was discharged from PICU 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Queen's University Belfast | Belfast | United Kingdom | BT7 1PT |
Sponsors and Collaborators
- Queen's University, Belfast
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EPS 22_57