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Self-Injurious BehaviorImaginatorNCT02914847

Imaginator: a Pilot of Brief Functional Imagery Training for Self-harm

A study testing Functional Imagery Training (FIT) in people with Self-Injurious Behavior, run by Medical Research Council at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Self-Injurious Behavior
What is being tested?
Functional Imagery Training (FIT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2016to Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Martina Di Simplicio contact

martina.disimplicio@mrc-cbu.cam.ac.uk

United Kingdom1 site
  • MRC CBU

    Cambridge, Cambridgeshire, CB2 7EF

    Elizabeth Appiah-Kusi, 00441223273614, elizabeth.appiah-kusi@mrc-cbu.cam.ac.uk

Other trials in United Kingdom

About this study

Official title: Imaginator: a Pilot of a Brief Functional Imagery Training Intervention for Self-harm in Young People, Supported by a Smart-phone 'App'

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.

Read the 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.

Being tested
Functional Imagery Training (FIT)
Medical subject headings
Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Imagery Training (FIT)Behavioural

    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.

Study groups in NCT02914847
Study groupRoleWhat they receive
Immediate Functional Imagery Training (FIT)ExperimentalParticipants in this arm receive Functional Imagery training (FIT) immediately.
Receives: Behavioral: Functional Imagery Training (FIT)
Delayed Functional Imagery Training (FIT)No interventionParticipants in this arm receive Functional Imagery Training (FIT) after a 3 month delay.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (18)
  1. Reduction of self-harm severity

    Average scores on severity of self-harm ratings over 3 months

    Measured: 3 months

  2. VAS reduction

    Average scores on a Visual Analogue Scale (VAS) scale of self-efficacy ratings referred to self-harm

    Measured: 3 months

  3. Imagery

    Average scores on characteristics of mental imagery associated with self-harm when present (e.g. vividness, compellingness)

    Measured: 3 months

  4. Clinical outcomes

    Average scores on clincial questionnaire 3 months after intervention

    Measured: 3 months

  5. 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

    Measured: 6 months

  6. 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.

    Measured: 3-6 months

  7. Feasibility Data Total

    Total number of participants referred to IMAGINATOR from different recruitment sources

    Measured: 3 months

  8. Reduction of self-harm modalities

    Average scores on self-harm modalities

    Measured: 3 months

  9. Reduction of Emergency Departments (ED) visits

    Number of Emergency Department (ED) visits

    Measured: 3 months

  10. Average scores on functional outcomes

    Average score on functional outcome

    Measured: 3 months

  11. Average score on process outcome

    Average score on process outcome measure

    Measured: 3 months

  12. 6 month (Emergency Department) ED visit

    Change from pre randomisation to 6 months after intervention on number of ED attendance episodes

    Measured: 6 months

  13. 6 month Clinical outcome

    Average scores on clincial questionnaire 6 months after intervention

    Measured: 6 months

  14. 6 month functional outcome

    Average scores on functional outcome 6 months after intervention

    Measured: 6 month

  15. 6 month process outcome

    Average scores on functional outcome 6 months after intervention

    Measured: 6 month

  16. Feasibility Data Monthly

    Monthly Recruitment Rate

    Measured: 3 month

  17. Feasibility data Attrition rate

    Attrition rate (percentage of participants completing intervention) comparing Delayed Functional Imagery Training (FIT) to Immediate FIT

    Measured: 3 month

  18. Feasibility Completion

    Completion rate of follow up assessments comparing Delayed Functional Imagery Training (FIT) to Immediate FIT

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02914847
Sponsor's protocol ID
16/LO/1311
Acronym
Imaginator
Status last verified
Oct 2016
First submitted
13 Sep 2016
Last updated
5 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33884617

Questions about this trial

What is this clinical trial studying?

A study testing Functional Imagery Training (FIT) in people with Self-Injurious Behavior, run by Medical Research Council at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martina Di Simplicio (martina.disimplicio@mrc-cbu.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduced Self-harm (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02914847, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.

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