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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary:

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 pers
Sponsor: Medical Research Council

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Reduction of self-harm severity [ Time Frame: 3 months ]
    Average scores on severity of self-harm ratingsattendance episodes for self-harm behaviour recorded in ED hospital records over 3 months
  • VAS reduction [ Time Frame: 3 months ]
    Average scores on a 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 ED visits [ Time Frame: 3 months ]
    Number of 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 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 FIT to Immediate FIT
  • Feasibility Completion [ Time Frame: 3 month ]
    Completion rate of follow up assessments comparing Delayed FIT to Immediate FIT


Information By: Medical Research Council

Dates:
Date Received: September 13, 2016
Date Started: September 2016
Date Completion: April 2017
Last Updated: October 4, 2016
Last Verified: October 2016