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Trial record 1 of 1 for:    NCT02463136
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Fmri-based Neurofeedback With Anxious Adolescents Study (NF-AA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02463136
Recruitment Status : Unknown
Verified November 2016 by University of Oxford.
Recruitment status was:  Recruiting
First Posted : June 4, 2015
Last Update Posted : November 10, 2016
King's College London
Cardiff University
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

Adolescents are particularly vulnerable to psychological problems, partly because of dramatic changes in the brain, along with changes in social interactions patterns as they move from childhood towards adulthood. One of the most common problems is anxiety, which affects up to 1 in 4 adolescents. Moreover, paediatric anxiety predicts lifelong persistent mental health problems, which are estimated to cost the UK taxpayer £8.6 billion annually. Young people with anxiety experience intense fears and worries, leading to problems with friendships, poor school performance, and long-term mental health difficulties. Research investigating how and why some young people develop anxiety is therefore critically needed so that strategies for early intervention can be developed.

This research will test the hypothesis that using a novel training intervention, - which teaches participants to change the way that their brain responds to emotional stimuli - will allow the investigators to influence response strategies while they are being established and possibly reduce the risk for anxiety in the long run. To achieve this, the investigators will test 50 adolescent females (aged 14-17 years) varying in anxiety levels to investigate whether brain responses in emotion regulation regions can be up/down regulated using fMRI-based neurofeedback.The rationale behind this research approach is that successful changes in brain response may then provide the participant with an additional, 'bodily' feeling of how respond to an emotional stimulus in real life situations, thereby paving the path towards the development of effective, age-appropriate intervention approaches.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: questionnaires Device: Functional magnetic resonance imaging w neurofeedback Phase 1

Detailed Description:

This study is part of workpackage 4 of the Braintrain project (EU-FP7 n°602186), which responds to a huge clinical need for mechanism-driven therapies in psychiatry. Advances in neuroimaging and other neuroscience techniques have produced a wealth of information about the neural networks that can contribute to these disorders and their treatment (Linden, 2012). This information can now be harnessed to pinpoint both dysfunction and potential compensatory mechanisms in individual patients. It is important for the choice of neuroimaging technique that major nodes of such disordered networks are in deep regions of the brain such as subcortical nuclei (amygdala and nucleus accumbens) and/or midline cortical regions (medial prefrontal cortex, subgenual cingulate cortex, retrosplenial cortex), which are very difficult to probe via EEG alone. Through the development of fMRI-based NF (henceforth NF) techniques over the last decade by collaboration of members of this consortium (Weiskopf et al., 2004a; Weiskopf et al., 2004b), it has become a realistic proposition to train patients in the self-regulation of these networks and thus obtain clinical benefits (deCharms, 2007). In addition to this therapeutic option, NF can also take the investigation of the neural mechanisms of mental disorders to a new level because it allows the investigators to establish causal relationships by changing regional activity and assessing effects on behaviour and mental states in real-time.

In the current study, the investigators aim to provide proof of concept for using NF with adolescents with varying anxiety levels aged 14-17 years. Anxiety disorders are common, having an estimated lifetime prevalence of 10-25%, and often begin in late childhood/early adolescence. There are currently no effective prevention programmes and current treatments yield variable outcomes. Improving our understanding of the mechanisms by which anxiety disorders first develop can inform the design of effective and targeted interventions for prevention. The transition to adolescence may mark one such developmentally-sensitive juncture for the onset of lifelong persistent anxiety problems, where new interventions such as NF may be particularly effective (Cohen Kadosh et al., 2013). Particularly, it has been suggested that increased emotionality and ongoing development in the neuro-cognitive bases of emotion regulation abilities during adolescence may be one of the factors contributing to the increased risk of anxiety disorders in this age group (Haller et al., in press).

This study builds on previous work by the investigators, which has established the suitability of using NF with paediatric populations (Cohen Kadosh et al., in preparation). Specifically, here, the investigators will use NF to train 50 adolescent girls with varying anxiety levels to increase effective connectivity in the neural networks involved in emotion regulation abilities (Cohen Kadosh et al., in preparation; Kohn et al., 2014; Ruiz et al., 2013). The rationale for this approach is that by improving the information flow in these brain regions, emotion regulation abilities will also improve. Moreover, the investigators hope to be able to show that in turn, improvements in emotion regulation abilities will affect overall anxiety levels. Last, by recruiting participants across a wide range of anxiety levels, the investigators will also be able to assess variations in regulation success as a function of individual anxiety levels.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Using Real-time fMRI-based Neurofeedback With Anxious Adolescents
Study Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Behaviour and brain training
fMRI-based neurofeedback
Behavioral: questionnaires
Clinical questionnaires and behavioural computer-based paradigms, such as the Overlap task (Cohen Kadosh et al., 2014)

Device: Functional magnetic resonance imaging w neurofeedback

The general framework of the scanning part of this experiment consists of a localiser task (lasting approximately 8 minutes), 4 neurofeedback runs (each lasting approximately 5 minutes) and an anatomical scan (approximately 10 minutes).

Immediately prior and following the scanning session, participants will also be asked to completed several), as well as an attentional control task with emotional stimuli, such as a behavioural version of the Overlap task (Cohen Kadosh et al., 2014).

Primary Outcome Measures :
  1. Proof of concept for using NF in anxious adolescents [ Time Frame: 12 months ]
    Primary outcome will be that anxious participants learn to self-regulate brain activation. This will be assessed by quantifying the percent signal change in the BOLD signal in specific brain regions.

Secondary Outcome Measures :
  1. Improved emotion regulation skills (questionnaires, behavioural tasks) [ Time Frame: 12 months ]
    Significant change in questionnaire scores

  2. Successful reduction in anxious mood (questionnaire) [ Time Frame: 12 months ]
    Significant reduction in anxiety scores

  3. Demographics (Demographic questionnaire) [ Time Frame: 12 months ]
    General assessment

  4. Thought control abilities (questionnaire) [ Time Frame: 12 months ]
    General assessment

  5. IQ levels (Wechsler Abbreviated Intelligence Scale) [ Time Frame: 12 months ]
    General assessment

  6. Emotion regulation skills (Cognitive Emotion Regulation Questionnaire) [ Time Frame: 12 months ]
    General assessment

  7. Mood and feelings (Moods and feelings questionnaire) [ Time Frame: 12 months ]
    General assessment

  8. Debriefing interview questionnaire [ Time Frame: 12 months ]
    General assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female
  • Aged 14-17 years
  • Trait-anxiety score between 20-60

Exclusion Criteria:

  • A past or current diagnosis of a psychological or psychiatric disorder, such as anxiety, depression, psychosis, autism, substance abuse, learning difficulties.
  • Known incompatibility with the scanner requirements, such as braces, non-removable piercings, tattoos or pregnancy.

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 identifier (NCT number): NCT02463136

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Contact: Kathrin Cohen Kadosh, PhD 01865 ext 271349
Contact: Jennifer YF Lau, PhD 0207790 ext 0253

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United Kingdom
University of Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX1 3UD
Contact: Kathrin Cohen Kadosh, PhD    ++44 1865 271349   
Sponsors and Collaborators
University of Oxford
King's College London
Cardiff University
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Principal Investigator: Kathrin ` Cohen Kadosh, PhD University of Oxford


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Responsible Party: University of Oxford Identifier: NCT02463136    
Other Study ID Numbers: MSD-IDREC-C2-2013-014
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be shared across the Braintrain consortium
Keywords provided by University of Oxford:
Brain Development