IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of Patients Lost to Attrition
研究概览
简要总结
This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK.
Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), a new version of the app that supports consolidation and practice of the techniques learnt in therapy was co-designed, and the protocol was adapted to be extended to younger adolescents.
Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions.
详细描述
An open single-arm study that investigates the IMAGINATOR intervention comprising of delivery of Functional Imagery Training (FIT) for self-harm supported by a new co-designed smartphone app for young people aged 12-25 who experience current repeated self-harming behaviour and have been referred to adult community mental health services (Mental Health Integrated Network Teams; MINT) or Community Child and Adolescent Mental Health Services (CAMHS).
For the purpose of this study, self-harm is defined as per NICE guidelines (NICE, 2012): "an act of self-poisoning or self-injury, irrespective of the apparent purpose of the act".
The IMAGINATOR intervention has been tested with 16-25 year olds using a proof of concept trial (Di Simplicio et al., 2020) but as the current study proposes to also include younger participants (12-17 year olds) and a newly co-produced version of the IMAGINATOR app, an open single-arm trial is the optimal design to assess the feasibility and acceptability of the new IMAGINATOR intervention following further protocol/materials development and with a different population.
The IMAGINATOR intervention provides three face-to-face sessions of FIT, followed by phone support sessions and smartphone app-based support, based on cognitive behavioural and motivational interviewing principles and in line with NICE guidelines for long-term management of self-harm behaviour. FIT is intended as a brief and focused transdiagnostic intervention that can be added to any other pharmacological or non-concurrent psychological therapy. To improve YP's access to and engagement with the intervention, FIT was combined with the new IMAGINATOR smartphone app.
The study is based in the West London NHS Trust.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12 - 25 years old
- •Presented with at least 2 episodes of self-harm lifetime, with at least 1 of these in the past month or 5 episodes of self-harm in the past year (based on NSSI Disorder criteria in the DSM-5) and currently reporting self-harm urges or difficulties stopping
- •Have a smartphone
- •Can commit to attending 3 consecutive weekly FIT sessions, and 5 follow-up telephone sessions, and assessments over follow up period as required by the study
- •Have adequate English language ability to permit the assessment and experimental measures to be completed, and use the smartphone app
- •Willing to consent to receive support to reduce / improve management of self-harm urges and behaviour; in person or by video, and over the phone and via smartphone app
- •If 12 - 15 years old, willing for parent/guardian to provide consent to study participation
- •Willing to have letters sent/phone calls made to their GP and other relevant clinicians
- •Resident within geographical areas covered by the West London NHS Trust CCAMHS and MINT teams.
排除标准
- •The participant may not enter the study if any of the following apply:
- •Severe learning disability or pervasive developmental disorder
- •Current acute psychotic episode
- •Current substance dependence
- •Imminent risk of suicide or harm to others (based on clinicians' risk assessment, see Section 4.1)
- •Insufficient English language fluency to complete study outcome measures
- •Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for self-harm
- •Unwilling to engage actively in the FIT intervention or to use an imagery-focused approach for treatment
- •Unwilling to use a smartphone app.
结局指标
主要结局
Number of Patients Lost to Attrition
时间窗: 1 year
Percentage of eligible enrolled participants not completing outcome assessment
Number of Patients Adhering to Treatment
时间窗: 3 months
Percentage of participants completing number of sessions as per-protocol (five sessions) out of the 27 participants who started therapy.
User Experience Questionnaire
时间窗: 3 months
This is an acceptability measure of app use designed to assess perceptions of the app, with items rated on a 7-point Likert scale ranging from -3 to +3. A score of -3 reflects the poorest user experience, while a score of +3 represents the highest level of satisfaction. A score of 0 indicates a neutral experience. The questionnaire consists of 26 items divided across six subscales: Attractiveness (overall impression), Perspicuity (ease of understanding), Efficiency (task completion speed), Dependability (reliability), Stimulation (engagement and enjoyment), and Novelty (innovation and creativity). For each of the six dimensions, the mean score of the items that correspond to that dimension is calculated. Higher scores across these subscales reflect a better overall user experience, while lower scores highlight specific areas for improvement. For the purposes of this analysis, the average of all dimensions mean scores were calculated for each participant.
Client Satisfaction Questionnaire (CSQ)
时间窗: 3 months
This is an 8 item version (Attkisson \& Zwick, 1982) designed to provide a sensitive and comprehensive assessment of patient satisfaction with the therapy received. This was only administered post-treatment and sum scores were calculated for each participant. Each item is rated on a 4-point Likert scale, where responses range from 1 (very dissatisfied) to 4 (very satisfied). The individual scores from each item are summed to produce a total score for each participant, with a possible range of 8 (indicating low satisfaction) to 32 (indicating high satisfaction). Higher scores on the CSQ reflect greater overall satisfaction with the therapy received.
次要结局
- Timeline Follow-Back Technique (TLFB)(3 months)
- Self-Harm Imagery Interview (PANAS+)(3 months)
- Self-Harm Imagery Interview (PANAS-)(3 months)
- State Motivation for Reducing Self-harm (SM-SH) Scale(3 months)
- Craving Experience Questionnaire for Self-Harm (CEQ-SH)(3 months)