IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People

Not Applicable

Completed

Conditions: Child Behavior Problem
Self Injurious Behavior
Adolescent Behavior Problem
Mental Health Disorder

Interventions: Other: Imaginator 2.0

Registration Number: NCT06311084

Lead Sponsor: Imperial College London

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaginator - Functional Imagery Training	Imaginator 2.0	3 weekly face to face sessions of Functional Imagery Training, followed by 5 fortnightly phone support calls, and the Imaginator app

Primary Outcome Measures

Name	Time	Method
Number of Patients Lost to Attrition	1 year	Percentage of eligible enrolled participants not completing outcome assessment
Number of Patients Adhering to Treatment	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	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)	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.

Secondary Outcome Measures

Name	Time	Method
Timeline Follow-Back Technique (TLFB)	3 months	This is an interview method conducted by the researcher who reconstructs together with the participant the number of self-harm behaviours using calendar cues. The scale records the total number of self-harm episodes within a specified timeframe of the last 3 months, with higher values indicating more frequent self-harm behaviours. The minimum number of episodes is 0 and the maximum number of episodes that can be reported for the 3 months is every day (so around 90 depending on the number of days of the month).
Self-Harm Imagery Interview (PANAS+)	3 months	This interview is about mental images that deal with self-harm or occur with self-harm. It asks participants to think about one of these and explores their thoughts and emotions in relation to the image. This measure specifically assesses positive emotions on a 10-item scale. Each item is rated on a 5-point Likert scale with responses ranging from 1 (not at all), very low intensity or absence of the specific emotion, to 5 (extremely), extremely high intensity of that emotion. Scores range from 10 to 50, where a score of 10 reflects low positive emotional intensity, indicating weak or minimal positive emotions associated with the imagery, while a score of 50 represents high positive emotional intensity, signifying strong and vivid positive emotions. Higher scores indicate a greater intensity of positive emotional experiences related to the imagery.
Self-Harm Imagery Interview (PANAS-)	3 months	This interview is about mental images that deal with self-harm or occur with self-harm. It asks participants to think about one of these and explores their thoughts and emotions in relation to the image. This measure specifically assesses negative emotions on a 10-item scale. Each item is rated on a 5-point Likert scale with responses ranging from 1 (not at all), no negative emotional intensity, to 5 (extremely), extremely high negative emotional intensity. Scores range from 10 to 50, where a score of 10 reflects low negative emotional intensity, indicating weak or minimal negative emotions associated with the imagery, while a score of 50 represents high negative emotional intensity, signifying strong and intense negative emotions. Higher scores indicate a greater intensity of negative emotional experiences related to the imagery.
State Motivation for Reducing Self-harm (SM-SH) Scale	3 months	This scale measures participants' motivation to control their self-harm through 12 items that measure the strength of their motivational cognitions in the present moment. Each item is rated on a 10-point Likert scale, ranging from 0 (never), indicating that the participant has no motivation or desire to control their self-harm at that moment, to 10 (constantly), , indicating that the participant has an extremely strong and persistent motivation to control their self-harm at that moment. Average scores are calculated for each participant ranging from 0 to 10, with higher scores indicating stronger motivation to control self-harm. This scale provides a sensitive measure of participants' current motivational state regarding self-harm reduction.
Craving Experience Questionnaire for Self-Harm (CEQ-SH)	3 months	This questionnaire assesses the urge to self-harm and assesses frequency, intensity, salience or dismissability of intrusive thoughts surrounding self-harm. It consists of 9 items, each rated on a 10-point Likert scale, ranging from 0 (not at all), indicating that the participant has no urge to self-harm or does not experience any intrusive thoughts related to self-harm, to 10 (constantly), indicating that the participant experiences a very strong and persistent urge to self-harm or is constantly preoccupied with thoughts of self-harm. The minimum score is 0, indicating no urge to self-harm, and the maximum score is 90, indicating the highest possible urge to self-harm. Higher scores reflect a stronger and more persistent urge to engage in self-harming behaviour.