Self Injurious BehaviorIMAG2NCT06311084
IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
A study testing Imaginator 2.0 in people with Self Injurious Behavior and Adolescent Behavior Problem, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Self Injurious Behavior, Adolescent Behavior Problem, Child Behavior Problem
- What is being tested?
- Imaginator 2.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2022to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Self Injurious Behavior, Adolescent Behavior Problem, Child Behavior Problem, Mental Health Disorder
- Being tested
- Imaginator 2.0
- Keywords
- Self Injurious Behaviour, Mental Health Disorder
- Medical subject headings
- Self-Injurious Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaginator 2.0Other
Blended psychological digital intervention, combining Functional Imagery Training, a psychological intervention based on CBT and motivational interviewing principles, and a smartphone app.
| Study group | Role | What they receive |
|---|---|---|
| Imaginator - Functional Imagery Training | Experimental | 3 weekly face to face sessions of Functional Imagery Training, followed by 5 fortnightly phone support calls, and the Imaginator app Receives: Other: Imaginator 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Lost to Attrition
Percentage of eligible enrolled participants not completing outcome assessment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start25 Nov 2022
- Primary completion9 Nov 2023
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Self Injurious BehaviorStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open ended feasibility and acceptability of novel blended digital psychological intervention
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311084
- Sponsor's protocol ID
- 310211
- Acronym
- IMAG2
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2024
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32057131Servi A, Gardner-Bougaard E, Mohamed S, McDermott A, Rodrigues R, Aveyard B, Van Zalk N, Hampshire A, Dewa L, Di Simplicio M. Early Evaluation of IMAGINATOR 2.0 Intervention Targeting Self-Harm in Young People: Single-Arm Feasibility Trial. JMIR Form Res. 2026 Jan 26;10:e79496. doi: 10.2196/79496.
PubMed 41587082
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People
- ClinicalTrials.gov ID
- NCT06311084
- Acronym / sponsor ID
- IMAG2 / 310211
- Conditions
- Self Injurious Behavior, Adolescent Behavior Problem, Child Behavior Problem, Mental Health Disorder
- Keywords
- Self Injurious Behaviour, Mental Health Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open ended feasibility and acceptability of novel blended digital psychological intervention
| Arm | Type | Receives |
|---|---|---|
| Imaginator - Functional Imagery Training | Experimental | Other: Imaginator 2.03 weekly face to face sessions of Functional Imagery Training, followed by 5 fortnightly phone support calls, and the Imaginator app |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaginator 2.0Blended psychological digital intervention, combining Functional Imagery Training, a psychological intervention based on CBT and motivational interviewing principles, and a smartphone app. | Other | Imaginator - Functional Imagery Training |
Primary outcome
Number of Patients Lost to Attrition
Time frame: 1 year
Percentage of eligible enrolled participants not completing outcome assessment
Number of Patients Adhering to Treatment
Time frame: 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
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Timeline Follow-Back Technique (TLFB)
Time frame: 3 months
Self-Harm Imagery Interview (PANAS+)
Time frame: 3 months
Self-Harm Imagery Interview (PANAS-)
Time frame: 3 months
State Motivation for Reducing Self-harm (SM-SH) Scale
Time frame: 3 months
Craving Experience Questionnaire for Self-Harm (CEQ-SH)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32057131Di 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.
- Derived from this study: PubMed 41587082Servi A, Gardner-Bougaard E, Mohamed S, McDermott A, Rodrigues R, Aveyard B, Van Zalk N, Hampshire A, Dewa L, Di Simplicio M. Early Evaluation of IMAGINATOR 2.0 Intervention Targeting Self-Harm in Young People: Single-Arm Feasibility Trial. JMIR Form Res. 2026 Jan 26;10:e79496. doi: 10.2196/79496.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaginator 2.0 in people with Self Injurious Behavior and Adolescent Behavior Problem, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Lost to Attrition (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06311084, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.