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Trial record 2 of 114 for:    Recruiting, Not yet recruiting, Available Studies | "Self-Injurious Behavior"

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

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ClinicalTrials.gov Identifier: NCT02914847
Recruitment Status : Not yet recruiting
First Posted : September 26, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Self-Injurious Behavior Behavioral: Functional Imagery Training (FIT)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Imaginator: a Pilot of a Brief Functional Imagery Training Intervention for Self-harm in Young People, Supported by a Smart-phone 'App'
Study Start Date : September 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-harm
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Immediate Functional Imagery Training (FIT)
Participants in this arm receive Functional Imagery training (FIT) immediately.
Behavioral: Functional Imagery Training (FIT)
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.
No Intervention: Delayed Functional Imagery Training (FIT)
Participants in this arm receive Functional Imagery Training (FIT) after a 3 month delay.


Outcome Measures

Primary Outcome Measures :
  1. Reduced Self-harm [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Reduction of self-harm severity [ Time Frame: 3 months ]
    Average scores on severity of self-harm ratings over 3 months

  2. VAS reduction [ Time Frame: 3 months ]
    Average scores on a Visual Analogue Scale (VAS) scale of self-efficacy ratings referred to self-harm

  3. Imagery [ Time Frame: 3 months ]
    Average scores on characteristics of mental imagery associated with self-harm when present (e.g. vividness, compellingness)

  4. Clinical outcomes [ Time Frame: 3 months ]
    Average scores on clincial questionnaire 3 months after intervention

  5. 6 month outcome self-efficacy [ Time Frame: 6 months ]
    Change from pre-randomization to 6 months after intervention in average scores on self-efficacy ratings on VAS scale referring to distress associated with self-harm

  6. Imaginator app [ Time Frame: 3-6 months ]
    Correlations between endpoints scores and the following measures of Imaginator app use: number of app sessions/logins and total duration of app use, number activity cycles completed, number of personalised media uploaded, number of completed guided imagery sessions and total duration of guided imagery completed, at 3 and 6 months after the intervention.

  7. Feasibility Data Total [ Time Frame: 3 months ]
    Total number of participants referred to IMAGINATOR from different recruitment sources

  8. Reduction of self-harm modalities [ Time Frame: 3 months ]
    Average scores on self-harm modalities

  9. Reduction of Emergency Departments (ED) visits [ Time Frame: 3 months ]
    Number of Emergency Department (ED) visits

  10. Average scores on functional outcomes [ Time Frame: 3 months ]
    Average score on functional outcome

  11. Average score on process outcome [ Time Frame: 3 months ]
    Average score on process outcome measure

  12. 6 month (Emergency Department) ED visit [ Time Frame: 6 months ]
    Change from pre randomisation to 6 months after intervention on number of ED attendance episodes

  13. 6 month Clinical outcome [ Time Frame: 6 months ]
    Average scores on clincial questionnaire 6 months after intervention

  14. 6 month functional outcome [ Time Frame: 6 month ]
    Average scores on functional outcome 6 months after intervention

  15. 6 month process outcome [ Time Frame: 6 month ]
    Average scores on functional outcome 6 months after intervention

  16. Feasibility Data Monthly [ Time Frame: 3 month ]
    Monthly Recruitment Rate

  17. Feasibility data Attrition rate [ Time Frame: 3 month ]
    Attrition rate (percentage of participants completing intervention) comparing Delayed Functional Imagery Training (FIT) to Immediate FIT

  18. Feasibility Completion [ Time Frame: 3 month ]
    Completion rate of follow up assessments comparing Delayed Functional Imagery Training (FIT) to Immediate FIT


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914847


Contacts
Contact: Martina Di Simplicio martina.disimplicio@mrc-cbu.cam.ac.uk

Locations
United Kingdom
MRC CBU Not yet recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 7EF
Contact: Elizabeth Appiah-Kusi    00441223273614    elizabeth.appiah-kusi@mrc-cbu.cam.ac.uk   
Sponsors and Collaborators
Medical Research Council
More Information

Additional Information:
Responsible Party: Martina DiSimplicio, Dr, Medical Research Council
ClinicalTrials.gov Identifier: NCT02914847     History of Changes
Other Study ID Numbers: 16/LO/1311
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms