Imaginator: a Pilot of Brief Functional Imagery Training for Self-harm (Imaginator)
Primary Purpose
Self-Injurious Behavior
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Functional Imagery Training (FIT)
Sponsored by
About this trial
This is an interventional treatment trial for Self-Injurious Behavior
Eligibility Criteria
Inclusion Criteria:
- Age 16 - 25 years old
- Have adequate English language ability to permit the assessment and experimental measures to be completed and use of the smartphone app
- Presented with at least 2 episodes of self-harm (defined in 2.2) over the last three months
- Willing to receive support to reduce / improve management of self-harm urges and behaviour in person, over the phone and via Android smartphone app (own or made available by researchers*)
- Willing to have letters sent/phone calls made to their General Practitioner (GP) and other relevant clinicians
- Can commit to attending 2 consecutive weekly sessions, and 5 fortnightly phone follow-up sessions, and assessments over follow up period as required by the study
- Resident within geographical areas covered by the Cambridgeshire and Peterborough NHS Foundation trust (CPFT)
- Able to give consent
Exclusion Criteria:
- Experiencing current severe psychopathology that is of impediment to completing the study requirements, e.g. active psychotic symptoms (clinicians assessment)
- Currently treated under the care of the CPFT Personality Disorders Pathway
- Currently under the care of the CPFT Crisis Resolution and Home Treatment Team or under inpatient care
- Learning difficulties, organic brain disease, severe neurological impairment
- Current severe substance or alcohol abuse (clinicians assessment)
- Presence of active suicidal risk on the Mini International Neuropsychiatric Interview (MINI) confirmed by convergent clinical opinion (see risk assessment protocol, Appendix 1)
- Unwilling to engage actively in the Functional Imagery Training (FIT) intervention or to use an imagery-focused approach for treatment
- Unwilling to use a smartphone app
- Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for self-harm
Sites / Locations
- MRC CBU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate Functional Imagery Training (FIT)
Delayed Functional Imagery Training (FIT)
Arm Description
Participants in this arm receive Functional Imagery training (FIT) immediately.
Participants in this arm receive Functional Imagery Training (FIT) after a 3 month delay.
Outcomes
Primary Outcome Measures
Reduced Self-harm
Change in the presence of and number of self-reported self-harm episodes over 3 months prior to the FIT intervention to over 3 months after randomization to the FIT intervention in the Immediate FIT + Standard Care (SC) group compared to the Delayed FIT + SC group.
Secondary Outcome Measures
Reduction of self-harm severity
Average scores on severity of self-harm ratings over 3 months
VAS reduction
Average scores on a Visual Analogue Scale (VAS) scale of self-efficacy ratings referred to self-harm
Imagery
Average scores on characteristics of mental imagery associated with self-harm when present (e.g. vividness, compellingness)
Clinical outcomes
Average scores on clincial questionnaire 3 months after intervention
6 month outcome self-efficacy
Change from pre-randomization to 6 months after intervention in average scores on self-efficacy ratings on VAS scale referring to distress associated with self-harm
Imaginator app
Correlations between endpoints scores and the following measures of Imaginator app use: number of app sessions/logins and total duration of app use, number activity cycles completed, number of personalised media uploaded, number of completed guided imagery sessions and total duration of guided imagery completed, at 3 and 6 months after the intervention.
Feasibility Data Total
Total number of participants referred to IMAGINATOR from different recruitment sources
Reduction of self-harm modalities
Average scores on self-harm modalities
Reduction of Emergency Departments (ED) visits
Number of Emergency Department (ED) visits
Average scores on functional outcomes
Average score on functional outcome
Average score on process outcome
Average score on process outcome measure
6 month (Emergency Department) ED visit
Change from pre randomisation to 6 months after intervention on number of ED attendance episodes
6 month Clinical outcome
Average scores on clincial questionnaire 6 months after intervention
6 month functional outcome
Average scores on functional outcome 6 months after intervention
6 month process outcome
Average scores on functional outcome 6 months after intervention
Feasibility Data Monthly
Monthly Recruitment Rate
Feasibility data Attrition rate
Attrition rate (percentage of participants completing intervention) comparing Delayed Functional Imagery Training (FIT) to Immediate FIT
Feasibility Completion
Completion rate of follow up assessments comparing Delayed Functional Imagery Training (FIT) to Immediate FIT
Full Information
NCT ID
NCT02914847
First Posted
September 13, 2016
Last Updated
October 4, 2016
Sponsor
Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT02914847
Brief Title
Imaginator: a Pilot of Brief Functional Imagery Training for Self-harm
Acronym
Imaginator
Official Title
Imaginator: a Pilot of a Brief Functional Imagery Training Intervention for Self-harm in Young People, Supported by a Smart-phone 'App'
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 mind's 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 mind's 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 (e.g. 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 (e.g. 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 (e.g. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Injurious Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Functional Imagery Training (FIT)
Arm Type
Experimental
Arm Description
Participants in this arm receive Functional Imagery training (FIT) immediately.
Arm Title
Delayed Functional Imagery Training (FIT)
Arm Type
No Intervention
Arm Description
Participants in this arm receive Functional Imagery Training (FIT) after a 3 month delay.
Intervention Type
Behavioral
Intervention Name(s)
Functional Imagery Training (FIT)
Intervention Description
Functional Imagery Training comprises of three elements: a) formulation of idiosyncratic drivers of self-harming behaviour and reasons for change; b) motivational interviewing combined with mental imagery techniques that enhance motivation to change the self-harm dysfunctional habit; c) formulation of goals for change (i.e. the goal is a desired behaviour alternative to self-harm) and practice of functional imagery to support goal achievement.
Primary Outcome Measure Information:
Title
Reduced Self-harm
Description
Change in the presence of and number of self-reported self-harm episodes over 3 months prior to the FIT intervention to over 3 months after randomization to the FIT intervention in the Immediate FIT + Standard Care (SC) group compared to the Delayed FIT + SC group.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Reduction of self-harm severity
Description
Average scores on severity of self-harm ratings over 3 months
Time Frame
3 months
Title
VAS reduction
Description
Average scores on a Visual Analogue Scale (VAS) scale of self-efficacy ratings referred to self-harm
Time Frame
3 months
Title
Imagery
Description
Average scores on characteristics of mental imagery associated with self-harm when present (e.g. vividness, compellingness)
Time Frame
3 months
Title
Clinical outcomes
Description
Average scores on clincial questionnaire 3 months after intervention
Time Frame
3 months
Title
6 month outcome self-efficacy
Description
Change from pre-randomization to 6 months after intervention in average scores on self-efficacy ratings on VAS scale referring to distress associated with self-harm
Time Frame
6 months
Title
Imaginator app
Description
Correlations between endpoints scores and the following measures of Imaginator app use: number of app sessions/logins and total duration of app use, number activity cycles completed, number of personalised media uploaded, number of completed guided imagery sessions and total duration of guided imagery completed, at 3 and 6 months after the intervention.
Time Frame
3-6 months
Title
Feasibility Data Total
Description
Total number of participants referred to IMAGINATOR from different recruitment sources
Time Frame
3 months
Title
Reduction of self-harm modalities
Description
Average scores on self-harm modalities
Time Frame
3 months
Title
Reduction of Emergency Departments (ED) visits
Description
Number of Emergency Department (ED) visits
Time Frame
3 months
Title
Average scores on functional outcomes
Description
Average score on functional outcome
Time Frame
3 months
Title
Average score on process outcome
Description
Average score on process outcome measure
Time Frame
3 months
Title
6 month (Emergency Department) ED visit
Description
Change from pre randomisation to 6 months after intervention on number of ED attendance episodes
Time Frame
6 months
Title
6 month Clinical outcome
Description
Average scores on clincial questionnaire 6 months after intervention
Time Frame
6 months
Title
6 month functional outcome
Description
Average scores on functional outcome 6 months after intervention
Time Frame
6 month
Title
6 month process outcome
Description
Average scores on functional outcome 6 months after intervention
Time Frame
6 month
Title
Feasibility Data Monthly
Description
Monthly Recruitment Rate
Time Frame
3 month
Title
Feasibility data Attrition rate
Description
Attrition rate (percentage of participants completing intervention) comparing Delayed Functional Imagery Training (FIT) to Immediate FIT
Time Frame
3 month
Title
Feasibility Completion
Description
Completion rate of follow up assessments comparing Delayed Functional Imagery Training (FIT) to Immediate FIT
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 16 - 25 years old
Have adequate English language ability to permit the assessment and experimental measures to be completed and use of the smartphone app
Presented with at least 2 episodes of self-harm (defined in 2.2) over the last three months
Willing to receive support to reduce / improve management of self-harm urges and behaviour in person, over the phone and via Android smartphone app (own or made available by researchers*)
Willing to have letters sent/phone calls made to their General Practitioner (GP) and other relevant clinicians
Can commit to attending 2 consecutive weekly sessions, and 5 fortnightly phone follow-up sessions, and assessments over follow up period as required by the study
Resident within geographical areas covered by the Cambridgeshire and Peterborough NHS Foundation trust (CPFT)
Able to give consent
Exclusion Criteria:
Experiencing current severe psychopathology that is of impediment to completing the study requirements, e.g. active psychotic symptoms (clinicians assessment)
Currently treated under the care of the CPFT Personality Disorders Pathway
Currently under the care of the CPFT Crisis Resolution and Home Treatment Team or under inpatient care
Learning difficulties, organic brain disease, severe neurological impairment
Current severe substance or alcohol abuse (clinicians assessment)
Presence of active suicidal risk on the Mini International Neuropsychiatric Interview (MINI) confirmed by convergent clinical opinion (see risk assessment protocol, Appendix 1)
Unwilling to engage actively in the Functional Imagery Training (FIT) intervention or to use an imagery-focused approach for treatment
Unwilling to use a smartphone app
Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for self-harm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Di Simplicio
Email
martina.disimplicio@mrc-cbu.cam.ac.uk
Facility Information:
Facility Name
MRC CBU
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 7EF
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Appiah-Kusi
Phone
00441223273614
Email
elizabeth.appiah-kusi@mrc-cbu.cam.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33884617
Citation
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Results Reference
derived
Links:
URL
http://www.nice.org.uk/guidance/cg133
Description
Self-harm in over 8s guidelines
URL
http://www.nccmh.org.uk
Description
National Collaborating Centre for Mental Health
URL
http://www.nice.org.uk/CG26
Description
Post Traumatic Stress Disorder Management
Learn more about this trial
Imaginator: a Pilot of Brief Functional Imagery Training for Self-harm
We'll reach out to this number within 24 hrs