Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311084
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2024-02-19
Brief Title:
IMAGINATOR 20 Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
IMAGINATOR 20 Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAG2
Brief Summary:
This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention Imaginator 20 targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK
Following an initial proof-of-concept study of Imaginator Di Simplicio et al 2020 we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy and adapted the protocol to be extended to younger adolescents
Imaginator 20 uses functional imagery training training in individuals to develop and use functional that is helpful mental images to support an alternative behaviour instead of self-harm Mental imagery is the process of picturing something in the mind and mental images have strong emotional and motivational characteristics Functional Imagery Training FIT within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions
Following an initial proof-of-concept study of Imaginator Di Simplicio et al 2020 we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy and adapted the protocol to be extended to younger adolescents
Imaginator 20 uses functional imagery training training in individuals to develop and use functional that is helpful mental images to support an alternative behaviour instead of self-harm Mental imagery is the process of picturing something in the mind and mental images have strong emotional and motivational characteristics Functional Imagery Training FIT within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions
Detailed Description:
An open single-arm study that investigates the IMAGINATOR intervention comprising of delivery of Functional Imagery Training FIT for self-harm supported by a new co-designed smartphone app for young people aged 12-25 who experience current repeated self-harming behaviour and have been referred to adult community mental health services Mental Health Integrated Network Teams MINT or Community Child and Adolescent Mental Health Services CAMHS
For the purpose of this study self-harm is defined as per NICE guidelines NICE 2012 an act of self-poisoning or self-injury irrespective of the apparent purpose of the act
The IMAGINATOR intervention has been tested with 16-25 year olds using a proof of concept trial Di Simplicio et al 2020 but as the current study proposes to also include younger participants 12-17 year olds and a newly co-produced version of the IMAGINATOR app an open single-arm trial is the optimal design to assess the feasibility and acceptability of the new IMAGINATOR intervention following further protocolmaterials development and with a different population
The IMAGINATOR intervention provides three face-to-face sessions of FIT followed by phone support sessions and smartphone app-based support based on cognitive behavioural and motivational interviewing principles and in line with NICE guidelines for long-term management of self-harm behaviour FIT is intended as a brief and focused transdiagnostic intervention that can be added to any other pharmacological or non-concurrent psychological therapy To improve YPs access to and engagement with the intervention we combine FIT the new IMAGINATOR smartphone app
The study is based in the West London NHS Trust
For the purpose of this study self-harm is defined as per NICE guidelines NICE 2012 an act of self-poisoning or self-injury irrespective of the apparent purpose of the act
The IMAGINATOR intervention has been tested with 16-25 year olds using a proof of concept trial Di Simplicio et al 2020 but as the current study proposes to also include younger participants 12-17 year olds and a newly co-produced version of the IMAGINATOR app an open single-arm trial is the optimal design to assess the feasibility and acceptability of the new IMAGINATOR intervention following further protocolmaterials development and with a different population
The IMAGINATOR intervention provides three face-to-face sessions of FIT followed by phone support sessions and smartphone app-based support based on cognitive behavioural and motivational interviewing principles and in line with NICE guidelines for long-term management of self-harm behaviour FIT is intended as a brief and focused transdiagnostic intervention that can be added to any other pharmacological or non-concurrent psychological therapy To improve YPs access to and engagement with the intervention we combine FIT the new IMAGINATOR smartphone app
The study is based in the West London NHS Trust
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None