IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People (IMAG2)

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Disorder; Child Behavior Problem; Self Injurious Behavior; Adolescent Behavior Problem
• Intervention / Treatment: Other: Imaginator 2.0

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • West London NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaginator - Functional Imagery Training; 3 weekly face to face sessions of Functional Imagery Training, followed by 5 fortnightly phone support calls, and the Imaginator app	Other: Imaginator 2.0; Blended psychological digital intervention, combining Functional Imagery Training, a psychological intervention based on CBT and motivational interviewing principles, and a smartphone app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Lost to Attrition	Percentage of eligible enrolled participants not completing outcome assessment	1 year
Number of Patients Adhering to Treatment	Percentage of participants completing number of sessions as per-protocol (five sessions) out of the 27 participants who started therapy.	3 months
User Experience Questionnaire	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.	3 months
Client Satisfaction Questionnaire (CSQ)	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeline Follow-Back Technique (TLFB)	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).	3 months
Self-Harm Imagery Interview (PANAS+)	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.	3 months
Self-Harm Imagery Interview (PANAS-)	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.	3 months
State Motivation for Reducing Self-harm (SM-SH) Scale	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.	3 months
Craving Experience Questionnaire for Self-Harm (CEQ-SH)	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Children's Anxiety and Depression Scale (RCADS) - Anxiety Subscale	This is a 47 item measure for 12-17 year olds with six sub-scales (separation anxiety disorder, social phobia, generalised anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder)). This analysis focuses on the Anxiety sub-scales (37 items), which consist of Separation Anxiety Disorder, Social Phobia, Generalised Anxiety Disorder, Panic Disorder, and Obsessive-Compulsive Disorder. Each item is scored from 0 (never), indicating not experiencing the symptom described in the item during the past week, to 3 (always), consistently experiencing the symptom. Total scores range from 0 to 111. A total score is calculated by summing the individual item scores. Higher scores indicate more severe anxiety. Here raw scores are reported.	3 months
Revised Children's Anxiety and Depression Scale (RCADS) - Depression Subscale	This is a 47 item measure for 12-17 year olds with six sub-scales (separation anxiety disorder, social phobia, generalised anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder)). This analysis specifically focuses on the Depression subscale (10 items). Each item is scored from 0 (never), indicating not experiencing the symptom described in the item during the past week, to 3 (always), consistently experiencing the symptom. Total scores range from 0 to 30. A total score is calculated by summing the individual item scores. Higher scores indicate more severe depression. Here raw scores are reported.	3 months
Depression, Anxiety and Stress Scale (DASS-21) - Depression Subscale	This is a 21-item scale for 18-25 year olds measuring levels of depression, anxiety and stress over the past week. This analysis focuses on the Depression subscale, which assesses symptoms associated with dysphoric mood, such as feelings of worthlessness. Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all), indicating that the individual did not experience depression symptoms during the past week to 3 (applied to me very much, or most of the time), indicating that the individual frequently experienced depression symptoms. The Depression subscale consists of 7 items, with scores ranging from 0 to 21. Since the DASS-21 is a short version of the full scale, the total score for the Depression subscale is calculated by summing the individual item scores and then multiplying the final score by 2. Higher scores on this subscale indicate more severe depression, reflecting a higher intensity of depressive symptoms in the past week.	3 months
Depression, Anxiety and Stress Scale (DASS-21) - Anxiety Subscale	This is a 21-item scale for 18-25 year olds measuring levels of depression, anxiety and stress over the past week. This analysis focuses on the Anxiety subscale, which measures symptoms associated with physiological arousal (e.g., trembling). Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all), indicating that the individual did not experience anxiety symptoms during the past week to 3 (applied to me very much, or most of the time), indicating that the individual frequently experienced anxiety symptoms. The Anxiety subscale includes 7 items, with scores ranging from 0 to 21. Since the DASS-21 is a short version of the full scale, the total score for the Anxiety subscale is calculated by summing the individual item scores and multiplying the final score by 2. Higher scores on this subscale indicate more severe anxiety, reflecting greater physiological arousal and anxiety symptoms experienced over the past week.	3 months
Depression, Anxiety and Stress Scale (DASS-21) - Stress Subscale	This is a 21-item scale for 18-25 year olds measuring levels of depression, anxiety and stress over the past week. This analysis focuses on the Stress subscale, which measures symptoms of tension and reactivity to stressful events. Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all), indicating that the individual did not experience stress symptoms during the past week to 3 (applied to me very much, or most of the time), indicating that the individual frequently experienced stress symptoms. The Stress subscale includes 7 items, with scores for this subscale ranging from 0 to 21. Since the DASS-21 is a short version of the full scale, the total score for the Stress subscale is calculated by summing the individual item scores and multiplying the final score by 2 to adjust for the reduced number of items. Higher scores on this subscale indicate more severe stress, reflecting greater tension and reactivity to stressors over the past week.	3 months
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)	This is a 14-item measure with positively worded items rated on a 5-point Likert scale, ranging from 1 to 5. A score of 1 ("none of the time") represents the lowest level of mental well-being, indicating that the individual rarely or never experiences the feelings or behaviors described in the item (e.g., feeling happy, confident, or connected). Conversely, a score of 5 ("all of the time") indicates the highest level of mental well-being, suggesting that the individual frequently or always experiences these positive mental health states. The total score is calculated by summing the individual item scores, with possible scores ranging from 14 to 70, where higher scores indicate better mental well-being and a greater level of positive mental health.	3 months
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)	This is an 18-item scale adapted from the original long version that measures general emotion regulation ability as well as various aspects of emotion regulation (in six subscales), e.g. difficulties engaging in goal directed behaviour when upset, and limited access to emotion regulation strategies. Each item is rated on a 5-point Likert scale, with 1 representing "Almost Never" (0-10% of the time), indicating minimal difficulty with emotion regulation, and 5 representing "Almost Always" (91-100% of the time), indicating frequent or almost constant difficulty. The total score is calculated by summing the item scores. The scale has a minimum value of 18 and a maximum value of 90. Higher scores indicate greater emotion regulation difficulties, reflecting more significant challenges in managing and regulating emotions. Conversely, lower scores suggest better emotion regulation skills and fewer difficulties in handling emotional responses.	3 months
11-item Behaviour Supplement to the Borderline Symptom List	This is an 11-item scale measuring engagement in other risky, self-destructive behaviours (e.g., binge eating, substance misuse). The items are designed to assess the frequency and severity of these behaviors, which are commonly associated with borderline personality disorder. Each item is rated on a Likert scale from 0 to 4, with 0 representing "Not at all", indicating no engagement in the behavior during the assessed period, and 4 representing "Daily or more often", indicating the participant engaged in the behavior on a daily basis or more frequently. The total score is calculated by summing the responses. The scale has a minimum value of 0 and a maximum value of 44, with higher scores indicating more frequent or severe engagement in these behaviors.	3 months
Alcohol Use Disorders Identification Test (AUDIT)	This is a 10-item measure of alcohol misuse and possible dependence, in which participants are asked to rate items related to their drinking (e.g. 'How often do you have a drink containing alcohol') on a 5-point scale ranging from 0 to 4. A score of 0 indicates "Never" engaging in the behavior (e.g., never drinking alcohol or never experiencing a specific consequence), while a score of 4 represents "Daily or almost daily", reflecting the highest level of engagement. The AUDIT is an effective means of identifying hazardous or harmful drinking behaviour. The total score is obtained by summing the individual item scores, with the scale ranging from 0 to 40. Higher scores indicate a greater risk of alcohol misuse, with scores of 8 or higher commonly used to identify individuals at risk for hazardous or harmful drinking. Conversely, lower scores suggest minimal or no alcohol-related problems.	3 months
Cannabis Use Disorder Identification Test Revised (CUDIT-R)	Thisis an 8-item measure used to screen for problem cannabis use. Participants are asked to rate a series of items related to their cannabis use (e.g., "How often do you use cannabis") on a 5-point Likert scale, where 0 represents "Never" or no engagement in the behavior, and 4 represents "Daily or almost daily", indicating the highest level of cannabis use. The total score is calculated by summing the responses, with the scale ranging from 0 to 40. A higher score indicates greater severity of cannabis misuse, and individuals with higher scores may be at risk for problematic cannabis use. Conversely, a lower score suggests minimal or no problematic cannabis use.	3 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: National Institute for Health Research, United Kingdom

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health Disorder; Self Injurious Behaviour
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders; Self-Injurious Behavior
• Other Study ID Numbers: 310211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No