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

NCT06311084 | Completed Results

• 1 other identifier: 310211
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Injurious Behavior; Adolescent Behavior Problem; Child Behavior Problem; Mental Health Disorder

Keywords

Self Injurious Behaviour; Mental Health Disorder

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Timeline Follow-Back Technique (TLFB)

  3 months

• Self-Harm Imagery Interview (PANAS+)

  3 months

• Self-Harm Imagery Interview (PANAS-)

  3 months

• State Motivation for Reducing Self-harm (SM-SH) Scale

  3 months

• Craving Experience Questionnaire for Self-Harm (CEQ-SH)

  3 months

Other Outcomes (10)

• Revised Children's Anxiety and Depression Scale (RCADS) - Anxiety Subscale

  3 months

• Revised Children's Anxiety and Depression Scale (RCADS) - Depression Subscale

  3 months

• Depression, Anxiety and Stress Scale (DASS-21) - Depression Subscale

  3 months

Study Arms (1)

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

Other: Imaginator 2.0

Interventions

Imaginator 2.0 OTHER

Blended psychological digital intervention, combining Functional Imagery Training, a psychological intervention based on CBT and motivational interviewing principles, and a smartphone app.

Imaginator - Functional Imagery Training

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

West London NHS Trust

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 32057131 BACKGROUND

• Servi 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.

  PMID: 41587082 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr Martina Di Simplicio
• Organization: Imperial College London

m.di-simplicio@imperial.ac.uk

0208 383 4162

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open ended feasibility and acceptability of novel blended digital psychological intervention

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 15, 2024
• Study Start: November 25, 2022
• Primary Completion: November 9, 2023
• Study Completion: January 23, 2024
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-03

Locations

GB (1)