Imaginator: a Pilot of Brief Functional Imagery Training for Self-harm

NCT02914847 | Unknown

• 1 other identifier: 16/LO/1311
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Self-harm has substantial personal impacts as well as costs on the National Health Service (NHS). Around 13-17% of young people report experiences of self-harm. In Cambridgeshire, this is a significant issue with the number of admissions to hospital for self-harm in young people being higher than the United Kingdom (UK) average. Treating underlying mental illness can lead to a reduction in self-harm, but these are long interventions for complex disorders and many people who self-harm are not under treatment for mental illness. Moreover, young people struggle to access traditional mental health services where these therapies are delivered. No short interventions specifically tailored for young people have been developed so far. The Imaginator project aims to address the urgent need for an effective and innovative short-term therapy for self-harm in young people. The investigators will pilot a new imagery-based psychological intervention for young people aged 16-25 who experience repetitive self-harm. Mental imagery (the experience of "seeing through the mind's eye") can carry intense emotions (positive and negative), and imagining something can facilitate behaviour. Imagery-based therapies have proven useful (i) for problems that feature intense, hard to manage emotions such as those associated with self-harm, and (ii) for promoting healthy behaviour. Our new intervention called Functional Imagery Training will support young people to imagine more adaptive behaviours to cope with the emotional distress that triggers self-harm, and motivate them to reduce self-harm. Imaginator will comprise of just two sessions followed by phone support over three months. Moreover, the investigators will address the challenge of young people accessing and staying in therapy by using a smartphone app to support the therapy, as apps are widely used and favoured by this age group. The app will enable participants to continue with the strategies they have learnt in therapy by themselves, thus ensuring a potential longer-term benefit and self-empowerment.

Conditions

Self-Injurious Behavior

Outcome Measures

Primary Outcomes (1)

• Reduced Self-harm

  Change in the presence of and number of self-reported self-harm episodes over 3 months prior to the FIT intervention to over 3 months after randomization to the FIT intervention in the Immediate FIT + Standard Care (SC) group compared to the Delayed FIT + SC group.

  3 months

Secondary Outcomes (18)

• Reduction of self-harm severity

  3 months

• VAS reduction

  3 months

• Imagery

  3 months

• Clinical outcomes

  3 months

• 6 month outcome self-efficacy

  6 months

Study Arms (2)

Immediate Functional Imagery Training (FIT)

EXPERIMENTAL

Participants in this arm receive Functional Imagery training (FIT) immediately.

Behavioral: Functional Imagery Training (FIT)

Delayed Functional Imagery Training (FIT)

NO INTERVENTION

Participants in this arm receive Functional Imagery Training (FIT) after a 3 month delay.

Interventions

Functional Imagery Training (FIT) BEHAVIORAL

Functional Imagery Training comprises of three elements: a) formulation of idiosyncratic drivers of self-harming behaviour and reasons for change; b) motivational interviewing combined with mental imagery techniques that enhance motivation to change the self-harm dysfunctional habit; c) formulation of goals for change (i.e. the goal is a desired behaviour alternative to self-harm) and practice of functional imagery to support goal achievement.

Immediate Functional Imagery Training (FIT)

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 16 - 25 years old
• Have adequate English language ability to permit the assessment and experimental measures to be completed and use of the smartphone app
• Presented with at least 2 episodes of self-harm (defined in 2.2) over the last three months
• Willing to receive support to reduce / improve management of self-harm urges and behaviour in person, over the phone and via Android smartphone app (own or made available by researchers\*)
• Willing to have letters sent/phone calls made to their General Practitioner (GP) and other relevant clinicians
• Can commit to attending 2 consecutive weekly sessions, and 5 fortnightly phone follow-up sessions, and assessments over follow up period as required by the study
• Resident within geographical areas covered by the Cambridgeshire and Peterborough NHS Foundation trust (CPFT)
• Able to give consent

You may not qualify if:

• Experiencing current severe psychopathology that is of impediment to completing the study requirements, e.g. active psychotic symptoms (clinicians assessment)
• Currently treated under the care of the CPFT Personality Disorders Pathway
• Currently under the care of the CPFT Crisis Resolution and Home Treatment Team or under inpatient care
• Learning difficulties, organic brain disease, severe neurological impairment
• Current severe substance or alcohol abuse (clinicians assessment)
• Presence of active suicidal risk on the Mini International Neuropsychiatric Interview (MINI) confirmed by convergent clinical opinion (see risk assessment protocol, Appendix 1)
• Unwilling to engage actively in the Functional Imagery Training (FIT) intervention or to use an imagery-focused approach for treatment
• Unwilling to use a smartphone app
• Taking part in concurrent treatment studies investigating pharmacological or psychological treatment for self-harm

Sponsors & Collaborators

• Medical Research Council: lead

Study Sites (1)

MRC CBU

Cambridge, Cambridgeshire, CB2 7EF, United Kingdom

Location

Related Publications (1)

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  PMID: 33884617 DERIVED

Related Links

• Self-harm in over 8s guidelines
• Post Traumatic Stress Disorder Management

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Martina Di Simplicio

CONTACT

martina.disimplicio@mrc-cbu.cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

GB (1)