N/A
N=29
IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
Self Injurious Behavior · Adolescent Behavior Problem · Child Behavior Problem · Mental Health Disorder
Bottom Line
View on ClinicalTrials.gov: NCT06311084 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Number of Patients Lost to Attrition — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imaginator 2.0 (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Lost to Attrition |
14 | — |
| PRIMARY Number of Patients Adhering to Treatment |
16 | — |
| PRIMARY User Experience Questionnaire |
0.65 | — |
| PRIMARY Client Satisfaction Questionnaire (CSQ) |
25 | — |
| SECONDARY Timeline Follow-Back Technique (TLFB) |
— | 0.05 |
| SECONDARY Self-Harm Imagery Interview (PANAS+) |
16 | 0.05 |
| SECONDARY Self-Harm Imagery Interview (PANAS-) |
36 | 0.05 |
| SECONDARY State Motivation for Reducing Self-harm (SM-SH) Scale |
6.33 | 0.05 |
| SECONDARY Craving Experience Questionnaire for Self-Harm (CEQ-SH) |
40 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06311084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.