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), we co-designed a new version of the app that supports consolidation and practice of the techniques learnt in therapy, and adapted the protocol 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, we combine FIT the new IMAGINATOR smartphone app.

The study is based in the West London NHS Trust.

• Study Type: Interventional
• Enrollment (Actual): 27
• 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
Attrition	Percentage of eligible enrolled participants completing outcome assessment	1 year
Treatment adherence	Percentage of participants completing number of sessions as per-protocol (five sessions)	3 months
Scores on User Experience Questionnaire	Acceptability measure of app use; positive scores indicate better user experience of the app.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of self harm episodes over 3 months	Self-harm frequency measured with the Timeline Followback Interview method	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving Experiences Questionnaire	Measure of self-harm urges; higher scores indicate greater urge to self-harm.	3 months
Difficulties in Emotion Regulation Scale	Measure of emotion regulation ability; higher scores indicate greater emotion regulation difficulties.	3 months
Depression, Anxiety, Stress Scale	Measure of low mood, anxiety and stress; higher scores indicate worse symptoms of depression, anxiety and stress.	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 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

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