CompletedNot Applicable

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

United Kingdom29 participantsStarted 2022-11-25

Plain-language 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.

Who can participate

Age range12 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

What they're measuring

Number of Patients Lost to Attrition

Timeframe: 1 year

Number of Patients Adhering to Treatment

Timeframe: 3 months

User Experience Questionnaire

Timeframe: 3 months

Client Satisfaction Questionnaire (CSQ)

Timeframe: 3 months

Trial details

NCT IDNCT06311084

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-09

Results submitted2025-01-28

View on ClinicalTrials.gov More Self Injurious Behavior trials

Plain-language summary

Who can participate

Age range12 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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