Remote Delivery of a Visuospatial Intervention to Reduce Traumatic Intrusive Memories After Paediatric Intensive Care

NCT05500105 | Completed

• 1 other identifier: EPS 22_57
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 intensive care.

Conditions

Intrusion Symptom

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, 1 week follow-up, and 1 month follow-up

• Intrusive memory ratings

  1 week follow-up and 1 month follow-up

• Patient Health Questionnaire-9 item (PHQ-9; Kroenke et al., 2001)

  Baseline, 1 week follow-up, and 1 month follow-up

• Generalised Anxiety Disorder-7 item questionnaire (GAD-7; Spitzer et al., 2006)

  Baseline, 1 week follow-up, and 1 month follow-up

• Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)

  Baseline, 1 week follow-up and 1 month follow-up

Other Outcomes (2)

• Self-administered use of the intervention

  1 week follow-up and 1 month follow-up

• Interview with participants regarding participation

  1 month follow-up

Study Arms (1)

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.

Other: Simple cognitive task intervention

Interventions

Simple cognitive task intervention OTHER

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.

Simple cognitive task intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Queen's University Belfast

Belfast, BT7 1PT, United Kingdom

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Doctorate in Clinical Psychology Programme

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 12, 2022
• Study Start: September 15, 2022
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

GB (1)