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

Mental Health Disorder Clinical Trial

— IMAG2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06311084
• Other study ID #: 310211
• Status: Completed
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: January 23, 2024

Study information

• Verified date: April 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 23, 2024
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Behavior Problem
• Mental Disorders
• Mental Health Disorder
• Problem Behavior
• Self Injurious Behavior
• Self-Injurious Behavior

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	West London NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Craving Experiences Questionnaire	Measure of self-harm urges; higher scores indicate greater urge to self-harm.	3 months
Other	Difficulties in Emotion Regulation Scale	Measure of emotion regulation ability; higher scores indicate greater emotion regulation difficulties.	3 months
Other	Depression, Anxiety, Stress Scale	Measure of low mood, anxiety and stress; higher scores indicate worse symptoms of depression, anxiety and stress.	3 months
Primary	Attrition	Percentage of eligible enrolled participants completing outcome assessment	1 year
Primary	Treatment adherence	Percentage of participants completing number of sessions as per-protocol (five sessions)	3 months
Primary	Scores on User Experience Questionnaire	Acceptability measure of app use; positive scores indicate better user experience of the app.	3 months
Secondary	Number of self harm episodes over 3 months	Self-harm frequency measured with the Timeline Followback Interview method	3 months