Imaginator: a Pilot of Brief Functional Imagery Training for Self-harm (Imaginator)
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|ClinicalTrials.gov Identifier: NCT02914847|
Recruitment Status : Unknown
Verified October 2016 by Martina DiSimplicio, Medical Research Council.
Recruitment status was: Not yet recruiting
First Posted : September 26, 2016
Last Update Posted : October 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Self-Injurious Behavior||Behavioral: Functional Imagery Training (FIT)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: Immediate Functional Imagery Training (FIT)
Participants in this arm receive Functional Imagery training (FIT) immediately.
Behavioral: Functional Imagery Training (FIT)
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.
No Intervention: Delayed Functional Imagery Training (FIT)
Participants in this arm receive Functional Imagery Training (FIT) after a 3 month delay.
- Reduced Self-harm [ Time Frame: 3 months ]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.
- Reduction of self-harm severity [ Time Frame: 3 months ]Average scores on severity of self-harm ratings over 3 months
- VAS reduction [ Time Frame: 3 months ]Average scores on a Visual Analogue Scale (VAS) scale of self-efficacy ratings referred to self-harm
- Imagery [ Time Frame: 3 months ]Average scores on characteristics of mental imagery associated with self-harm when present (e.g. vividness, compellingness)
- Clinical outcomes [ Time Frame: 3 months ]Average scores on clincial questionnaire 3 months after intervention
- 6 month outcome self-efficacy [ Time Frame: 6 months ]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 [ Time Frame: 3-6 months ]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 [ Time Frame: 3 months ]Total number of participants referred to IMAGINATOR from different recruitment sources
- Reduction of self-harm modalities [ Time Frame: 3 months ]Average scores on self-harm modalities
- Reduction of Emergency Departments (ED) visits [ Time Frame: 3 months ]Number of Emergency Department (ED) visits
- Average scores on functional outcomes [ Time Frame: 3 months ]Average score on functional outcome
- Average score on process outcome [ Time Frame: 3 months ]Average score on process outcome measure
- 6 month (Emergency Department) ED visit [ Time Frame: 6 months ]Change from pre randomisation to 6 months after intervention on number of ED attendance episodes
- 6 month Clinical outcome [ Time Frame: 6 months ]Average scores on clincial questionnaire 6 months after intervention
- 6 month functional outcome [ Time Frame: 6 month ]Average scores on functional outcome 6 months after intervention
- 6 month process outcome [ Time Frame: 6 month ]Average scores on functional outcome 6 months after intervention
- Feasibility Data Monthly [ Time Frame: 3 month ]Monthly Recruitment Rate
- Feasibility data Attrition rate [ Time Frame: 3 month ]Attrition rate (percentage of participants completing intervention) comparing Delayed Functional Imagery Training (FIT) to Immediate FIT
- Feasibility Completion [ Time Frame: 3 month ]Completion rate of follow up assessments comparing Delayed Functional Imagery Training (FIT) to Immediate FIT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914847
|Contact: Martina Di Simpliciofirstname.lastname@example.org|
|MRC CBU||Not yet recruiting|
|Cambridge, Cambridgeshire, United Kingdom, CB2 7EF|
|Contact: Elizabeth Appiah-Kusi 00441223273614 email@example.com|