Ignite Creation Date:
2024-05-06 @ 9:08 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02914847
Status:
UNKNOWN
Last Update Posted:
2016-10-05
First Post:
2016-09-13
Brief Title:
Imaginator a Pilot of Brief Functional Imagery Training for Self-harm
Sponsor:
Medical Research Council
Organization:
Medical Research Council
Study Overview
Official Title:
Imaginator a Pilot of a Brief Functional Imagery Training Intervention for Self-harm in Young People Supported by a Smart-phone App
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
NOT_YET_RECRUITING
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:
Imaginator
Brief Summary:
Self-harm has substantial personal impacts as well as costs on the National Health Service NHS Around 13-17 of young people report experiences of self-harm In Cambridgeshire this is a significant issue with the number of admissions to hospital for self-harm in young people being higher than the United Kingdom UK average Treating underlying mental illness can lead to a reduction in self-harm but these are long interventions for complex disorders and many people who self-harm are not under treatment for mental illness Moreover young people struggle to access traditional mental health services where these therapies are delivered No short interventions specifically tailored for young people have been developed so far
The Imaginator project aims to address the urgent need for an effective and innovative short-term therapy for self-harm in young people The investigators will pilot a new imagery-based psychological intervention for young people aged 16-25 who experience repetitive self-harm Mental imagery the experience of seeing through the minds eye can carry intense emotions positive and negative and imagining something can facilitate behaviour Imagery-based therapies have proven useful i for problems that feature intense hard to manage emotions such as those associated with self-harm and ii for promoting healthy behaviour Our new intervention called Functional Imagery Training will support young people to imagine more adaptive behaviours to cope with the emotional distress that triggers self-harm and motivate them to reduce self-harm Imaginator will comprise of just two sessions followed by phone support over three months
Moreover the investigators will address the challenge of young people accessing and staying in therapy by using a smartphone app to support the therapy as apps are widely used and favoured by this age group The app will enable participants to continue with the strategies they have learnt in therapy by themselves thus ensuring a potential longer-term benefit and self-empowerment
The Imaginator project aims to address the urgent need for an effective and innovative short-term therapy for self-harm in young people The investigators will pilot a new imagery-based psychological intervention for young people aged 16-25 who experience repetitive self-harm Mental imagery the experience of seeing through the minds eye can carry intense emotions positive and negative and imagining something can facilitate behaviour Imagery-based therapies have proven useful i for problems that feature intense hard to manage emotions such as those associated with self-harm and ii for promoting healthy behaviour Our new intervention called Functional Imagery Training will support young people to imagine more adaptive behaviours to cope with the emotional distress that triggers self-harm and motivate them to reduce self-harm Imaginator will comprise of just two sessions followed by phone support over three months
Moreover the investigators will address the challenge of young people accessing and staying in therapy by using a smartphone app to support the therapy as apps are widely used and favoured by this age group The app will enable participants to continue with the strategies they have learnt in therapy by themselves thus ensuring a potential longer-term benefit and self-empowerment
Detailed Description:
The problem of self-harm and the need short interventions for young people
Self-harm an act of self-poisoning or self-injury irrespective of the apparent purpose of the act is a behaviour used to cope with intense emotions and psychological distress It can occur in a variety of mental health diagnoses as well as individuals with no diagnosis Of concern is that almost one in five young adults report self-harm behaviour A United Kingdom UK survey in schools described 13 15-16 years old had self-harmed during their life and 8 in the last year Factors associated with self-harm include a disadvantaged socio-economic background social isolation and lack of support negative life events including childhood emotional physical or sexual abuse Although self-harm is different from suicidality people who self-harm carry a fourfold risk of suicidal thoughts and behaviours within one year a risk over and above risk conferred by mental health problems and psychosocial risk factors
Self-harm has substantial personal impacts and costs on the National Health Service NHS In Cambridgeshire the number of hospital admissions for self-harm has been higher than the UK average making addressing self-harm a significant issue for local primary and secondary health care National Institute for Clinical Excellence NICE guidelines recommend offering a psychological intervention that is specifically structured for people who self-harm with the aim of reducing self-harm In addition i the intervention should be tailored to individual need and could include cognitive-behavioural psychodynamic or problem-solving elements ii therapists should be trained and supervised in the therapy they are offering to people who self-harm iii therapists should also be able to work collaboratively with the person to identify the problems causing distress or leading to self-harm A number of interventions have been developed and have shown some efficacy at reducing self-harm in adolescents and adults However these therapies vary between 4 sessions and much longer duration and currently are mostly available only to individuals under mental health care after variable periods of waiting time Moreover almost half of young people referred recommended treatment will not attend any follow-up sessions There is a lack of short interventions for self-harm specifically targeted at young people Short interventions that engage young people are urgently needed to allow young people to better manage and reduce self-harm also outside secondary mental health care and alongside while waiting for more longterm problems to be addressed psychiatric disorders housing and employment difficulties etc
Developing new treatments for self-harm using imagery-based interventions
Mental imagery is the process of seeing through the minds eye Intrusive mental images carrying intense negative emotions are central to several mental disorders For example individuals with social anxiety will experience intrusive images of them sweating and blushing intensely while they try to speak to someone these images will fuel their anxiety about being judged by others and possibly stop them from attending further social situations Mental imagery associated with self-harm also appears to be a common phenomenon and individuals describe that images associated with self-harm can carry many different emotional meanings eg evoking a sense of relief or increasing the urge to self-harm in line with what drives self-harm in every individual The characteristics of mental images are related to the intensity of emotions and this applies to positive emotions too For example more vivid positive imagery has been related to greater excitement during positive mood
Overall this suggests that mental imagery is a common phenomenon which many individuals are likely to experience in the context of high emotions and that mental images could be used to generate helpful emotions In fact addressing distressing mental images and promoting positive imagery has been used for trauma depression and self-harm in personality disorders The investigators have successfully treated cases with self-harm behaviour using a short course of imagery-focused therapy for Bipolar Disorder
Moreover mental images can promote behaviour Imagining something makes it more likely to act because it simulating the actual event in the mind and it allows individuals to pre-experience all aspects the event Hence via imagining future scenarios individuals may feel more ready to engage in the action successfully For example in sports adding mental imagery training visualising an exercise to physical practice of an exercise improves performance Moreover imagining an action also involves anticipating how emotionally rewarding it is likely to be This may enhance motivation to act The more vivid and real-like the mental image of completing a desired action is the stronger the positive emotion and motivation to actually do it This type of imagery of healthy behaviour and desired actions has been developed into a therapy called Functional Imagery Training FIT FIT encourages individuals to imagine the benefits of working towards their goals especially the benefits that are expected to happen right away eg feeling good about oneself
So far FIT has been shown to be a successful approach for interventions to reduce snacking and in addictive behaviours
Based on this the investigators propose that FIT can train individuals to imagine more helpful behaviours rather than self-harm when distressed FIT will train vivid and real-like imagery of alternative goals to self-harm which is likely to produce rewarding and positive emotions Our FIT protocol will aim to support individuals who self-harm at
i identifying helpful behaviours as an alternative goal when they feel like self-harming eg going for a run listening to music ii by practising mental imagery of the alternative behaviour boosting the desire to achieve this goal iii succeeding in engaging in alternative behaviours to self-harm
Importantly FIT will consist of two face-to-face sessions plus five brief telephone support sessions Therefore it has the potential of offering immediate support for all those young people who are either excluded from or waiting for more complex interventions
The challenge of engaging young people
Imagery-based interventions focus on visual techniques and are easily amenable to be supported by a smartphone app Smartphone usage by young people is high Therefore enhancing a psychological intervention via a smartphone app could be a successful strategy to ensure that young people keep practising the therapy techniques and engaging with what was learned in therapy once the sessions are over and without the need of face to face follow-up The support of a smartphone app following the FIT sessions can aid overcome barriers to engagement reported in young people
Therefore the Imaginator study will tailor FIT to young people by adding a smartphone app support which can make the intervention more interesting and approachable to this age group The investigators have developed a bespoke app called Imaginator This app was created collectively via six meetings of a Young People Advisory Group YPAG 4 members 1 male aged 19 to 22 years old with a lived experience of self-harm together with the research team and John Harper from App Shine Development company
In summary self-harm behaviour is a highly prevalent problem among young people in the UK and worldwide and of particular urgency in Cambridgeshire It represents a major social and healthcare problem for the community Currently there is a lack of short and easily accessible interventions to specifically help young people reduce self-harming behaviour As mental imagery-based techniques have been used to reduce unwanted emotions and support motivation and helpful behaviour The investigators propose that Functional Imagery Training FIT could represent a successful strategy to reduce self-harm behaviour FIT is intended as a brief and focused intervention for young people aged 16-25 regardless of any diagnosis that can be added to any other pharmacological or psychological therapy To improve access to and engagement with the intervention by young people the investigators will deliver FIT supported by a smartphone app developed together with a Young People Advisory Group
Self-harm an act of self-poisoning or self-injury irrespective of the apparent purpose of the act is a behaviour used to cope with intense emotions and psychological distress It can occur in a variety of mental health diagnoses as well as individuals with no diagnosis Of concern is that almost one in five young adults report self-harm behaviour A United Kingdom UK survey in schools described 13 15-16 years old had self-harmed during their life and 8 in the last year Factors associated with self-harm include a disadvantaged socio-economic background social isolation and lack of support negative life events including childhood emotional physical or sexual abuse Although self-harm is different from suicidality people who self-harm carry a fourfold risk of suicidal thoughts and behaviours within one year a risk over and above risk conferred by mental health problems and psychosocial risk factors
Self-harm has substantial personal impacts and costs on the National Health Service NHS In Cambridgeshire the number of hospital admissions for self-harm has been higher than the UK average making addressing self-harm a significant issue for local primary and secondary health care National Institute for Clinical Excellence NICE guidelines recommend offering a psychological intervention that is specifically structured for people who self-harm with the aim of reducing self-harm In addition i the intervention should be tailored to individual need and could include cognitive-behavioural psychodynamic or problem-solving elements ii therapists should be trained and supervised in the therapy they are offering to people who self-harm iii therapists should also be able to work collaboratively with the person to identify the problems causing distress or leading to self-harm A number of interventions have been developed and have shown some efficacy at reducing self-harm in adolescents and adults However these therapies vary between 4 sessions and much longer duration and currently are mostly available only to individuals under mental health care after variable periods of waiting time Moreover almost half of young people referred recommended treatment will not attend any follow-up sessions There is a lack of short interventions for self-harm specifically targeted at young people Short interventions that engage young people are urgently needed to allow young people to better manage and reduce self-harm also outside secondary mental health care and alongside while waiting for more longterm problems to be addressed psychiatric disorders housing and employment difficulties etc
Developing new treatments for self-harm using imagery-based interventions
Mental imagery is the process of seeing through the minds eye Intrusive mental images carrying intense negative emotions are central to several mental disorders For example individuals with social anxiety will experience intrusive images of them sweating and blushing intensely while they try to speak to someone these images will fuel their anxiety about being judged by others and possibly stop them from attending further social situations Mental imagery associated with self-harm also appears to be a common phenomenon and individuals describe that images associated with self-harm can carry many different emotional meanings eg evoking a sense of relief or increasing the urge to self-harm in line with what drives self-harm in every individual The characteristics of mental images are related to the intensity of emotions and this applies to positive emotions too For example more vivid positive imagery has been related to greater excitement during positive mood
Overall this suggests that mental imagery is a common phenomenon which many individuals are likely to experience in the context of high emotions and that mental images could be used to generate helpful emotions In fact addressing distressing mental images and promoting positive imagery has been used for trauma depression and self-harm in personality disorders The investigators have successfully treated cases with self-harm behaviour using a short course of imagery-focused therapy for Bipolar Disorder
Moreover mental images can promote behaviour Imagining something makes it more likely to act because it simulating the actual event in the mind and it allows individuals to pre-experience all aspects the event Hence via imagining future scenarios individuals may feel more ready to engage in the action successfully For example in sports adding mental imagery training visualising an exercise to physical practice of an exercise improves performance Moreover imagining an action also involves anticipating how emotionally rewarding it is likely to be This may enhance motivation to act The more vivid and real-like the mental image of completing a desired action is the stronger the positive emotion and motivation to actually do it This type of imagery of healthy behaviour and desired actions has been developed into a therapy called Functional Imagery Training FIT FIT encourages individuals to imagine the benefits of working towards their goals especially the benefits that are expected to happen right away eg feeling good about oneself
So far FIT has been shown to be a successful approach for interventions to reduce snacking and in addictive behaviours
Based on this the investigators propose that FIT can train individuals to imagine more helpful behaviours rather than self-harm when distressed FIT will train vivid and real-like imagery of alternative goals to self-harm which is likely to produce rewarding and positive emotions Our FIT protocol will aim to support individuals who self-harm at
i identifying helpful behaviours as an alternative goal when they feel like self-harming eg going for a run listening to music ii by practising mental imagery of the alternative behaviour boosting the desire to achieve this goal iii succeeding in engaging in alternative behaviours to self-harm
Importantly FIT will consist of two face-to-face sessions plus five brief telephone support sessions Therefore it has the potential of offering immediate support for all those young people who are either excluded from or waiting for more complex interventions
The challenge of engaging young people
Imagery-based interventions focus on visual techniques and are easily amenable to be supported by a smartphone app Smartphone usage by young people is high Therefore enhancing a psychological intervention via a smartphone app could be a successful strategy to ensure that young people keep practising the therapy techniques and engaging with what was learned in therapy once the sessions are over and without the need of face to face follow-up The support of a smartphone app following the FIT sessions can aid overcome barriers to engagement reported in young people
Therefore the Imaginator study will tailor FIT to young people by adding a smartphone app support which can make the intervention more interesting and approachable to this age group The investigators have developed a bespoke app called Imaginator This app was created collectively via six meetings of a Young People Advisory Group YPAG 4 members 1 male aged 19 to 22 years old with a lived experience of self-harm together with the research team and John Harper from App Shine Development company
In summary self-harm behaviour is a highly prevalent problem among young people in the UK and worldwide and of particular urgency in Cambridgeshire It represents a major social and healthcare problem for the community Currently there is a lack of short and easily accessible interventions to specifically help young people reduce self-harming behaviour As mental imagery-based techniques have been used to reduce unwanted emotions and support motivation and helpful behaviour The investigators propose that Functional Imagery Training FIT could represent a successful strategy to reduce self-harm behaviour FIT is intended as a brief and focused intervention for young people aged 16-25 regardless of any diagnosis that can be added to any other pharmacological or psychological therapy To improve access to and engagement with the intervention by young people the investigators will deliver FIT supported by a smartphone app developed together with a Young People Advisory Group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None