Clinical trial NCT06311084: IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
Official title: IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Injurious Behavior
Adolescent Behavior Problem
Child Behavior Problem
Mental Health Disorder
Keywords: Self Injurious Behaviour
Mental Health Disorder
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2024-03-15
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open ended feasibility and acceptability of novel blended digital psychological intervention
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 12 - 25 years old
2. 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
3. Have a smartphone
4. 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
5. Have adequate English language ability to permit the assessment and experimental measures to be completed, and use the smartphone app
6. 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
7. If 12 - 15 years old, willing for parent/guardian to provide consent to study participation
8. Willing to have letters sent/phone calls made to their GP and other relevant clinicians
9. Resident within geographical areas covered by the West London NHS Trust CCAMHS and MINT teams.

Exclusion Criteria:

The participant may not enter the study if any of the following apply:

1. Severe learning disability or pervasive developmental disorder
2. Current acute psychotic episode
3. Current substance dependence
4. Imminent risk of suicide or harm to others (based on clinicians' risk assessment, see Section 4.1)
5. Insufficient English language fluency to complete study outcome measures
6. Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for self-harm
7. Unwilling to engage actively in the FIT intervention or to use an imagery-focused approach for treatment
8. Unwilling to use a smartphone app.

Primary outcomes:
measure: Number of Patients Lost to Attrition
timeFrame: 1 year
measure: Number of Patients Adhering to Treatment
timeFrame: 3 months
measure: User Experience Questionnaire
timeFrame: 3 months
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 3 months
Secondary outcomes:
measure: Timeline Follow-Back Technique (TLFB)
timeFrame: 3 months
measure: Self-Harm Imagery Interview (PANAS+)
timeFrame: 3 months
measure: Self-Harm Imagery Interview (PANAS-)
timeFrame: 3 months
measure: State Motivation for Reducing Self-harm (SM-SH) Scale
timeFrame: 3 months
measure: Craving Experience Questionnaire for Self-Harm (CEQ-SH)
timeFrame: 3 months
Other outcomes:
measure: Revised Children's Anxiety and Depression Scale (RCADS) - Anxiety Subscale
timeFrame: 3 months
measure: Revised Children's Anxiety and Depression Scale (RCADS) - Depression Subscale
timeFrame: 3 months
measure: Depression, Anxiety and Stress Scale (DASS-21) - Depression Subscale
timeFrame: 3 months
measure: Depression, Anxiety and Stress Scale (DASS-21) - Anxiety Subscale
timeFrame: 3 months
measure: Depression, Anxiety and Stress Scale (DASS-21) - Stress Subscale
timeFrame: 3 months
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: 3 months
measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
timeFrame: 3 months
measure: 11-item Behaviour Supplement to the Borderline Symptom List
timeFrame: 3 months
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 3 months
measure: Cannabis Use Disorder Identification Test Revised (CUDIT-R)
timeFrame: 3 months
Locations:
city: London
country: United Kingdom
facility: West London NHS Trust
Study officials:
References:
citation: Di Simplicio M, Appiah-Kusi E, Wilkinson P, Watson P, Meiser-Stedman C, Kavanagh DJ, Holmes EA. Imaginator: A Proof-of-Concept Feasibility Trial of a Brief Imagery-Based Psychological Intervention for Young People Who Self-Harm. Suicide Life Threat Behav. 2020 Jun;50(3):724-740. doi: 10.1111/sltb.12620. Epub 2020 Feb 14.