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临床试验/NCT02914847
NCT02914847Unknown不适用

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

Medical Research Council1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Reduced Self-harm

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Immediate Functional Imagery Training (FIT)

Experimental

Participants in this arm receive Functional Imagery training (FIT) immediately.

干预措施: Functional Imagery Training (FIT) (Behavioral)

Delayed Functional Imagery Training (FIT)

No Intervention

Participants in this arm receive Functional Imagery Training (FIT) after a 3 month delay.

结局指标

主要结局

Reduced Self-harm

时间窗: 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.

次要结局

  • 6 month Clinical outcome(6 months)
  • Reduction of self-harm severity(3 months)
  • VAS reduction(3 months)
  • Clinical outcomes(3 months)
  • Imaginator app(3-6 months)
  • Average score on process outcome(3 months)
  • Imagery(3 months)
  • 6 month outcome self-efficacy(6 months)
  • Feasibility Data Monthly(3 month)
  • Reduction of self-harm modalities(3 months)
  • 6 month (Emergency Department) ED visit(6 months)
  • 6 month functional outcome(6 month)
  • 6 month process outcome(6 month)
  • Feasibility Completion(3 month)
  • Feasibility Data Total(3 months)
  • Reduction of Emergency Departments (ED) visits(3 months)
  • Average scores on functional outcomes(3 months)
  • Feasibility data Attrition rate(3 month)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Martina DiSimplicio

Dr

Medical Research Council

研究点 (1)

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