Fmri-based Neurofeedback With Anxious Adolescents Study

Anxiety Clinical Trial

— NF-AA  

Official title:

Using Real-time fMRI-based Neurofeedback With Anxious Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02463136
• Other study ID #: MSD-IDREC-C2-2013-014
• Status: Recruiting
• Phase: Phase 1
• First received: May 22, 2015
• Last updated: November 9, 2016
• Start date: November 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2016
• Source: University of Oxford
• Contact: Kathrin Cohen Kadosh, PhD
• Phone: 01865
• Email: kathrin.cohenkadosh[@]psy.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 17 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Cardiff University, King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

Cohen Kadosh K, Linden DE, Lau JY. Plasticity during childhood and adolescence: innovative approaches to investigating neurocognitive development. Dev Sci. 2013 Jul;16(4):574-83. doi: 10.1111/desc.12054. — View Citation

deCharms RC. Reading and controlling human brain activation using real-time functional magnetic resonance imaging. Trends Cogn Sci. 2007 Nov;11(11):473-81. Review. — View Citation

Haller SP, Cohen Kadosh K, Scerif G, Lau JY. Social anxiety disorder in adolescence: How developmental cognitive neuroscience findings may shape understanding and interventions for psychopathology. Dev Cogn Neurosci. 2015 Jun;13:11-20. doi: 10.1016/j.dcn.2015.02.002. Review. — View Citation

Kohn N, Eickhoff SB, Scheller M, Laird AR, Fox PT, Habel U. Neural network of cognitive emotion regulation--an ALE meta-analysis and MACM analysis. Neuroimage. 2014 Feb 15;87:345-55. doi: 10.1016/j.neuroimage.2013.11.001. Erratum in: Neuroimage. 2015 May 1;111():631. — View Citation

Linden DE. The challenges and promise of neuroimaging in psychiatry. Neuron. 2012 Jan 12;73(1):8-22. doi: 10.1016/j.neuron.2011.12.014. Review. — View Citation

Ruiz S, Lee S, Soekadar SR, Caria A, Veit R, Kircher T, Birbaumer N, Sitaram R. Acquired self-control of insula cortex modulates emotion recognition and brain network connectivity in schizophrenia. Hum Brain Mapp. 2013 Jan;34(1):200-12. doi: 10.1002/hbm.21427. — View Citation

Weiskopf N, Mathiak K, Bock SW, Scharnowski F, Veit R, Grodd W, Goebel R, Birbaumer N. Principles of a brain-computer interface (BCI) based on real-time functional magnetic resonance imaging (fMRI). IEEE Trans Biomed Eng. 2004 Jun;51(6):966-70. — View Citation

Weiskopf N, Scharnowski F, Veit R, Goebel R, Birbaumer N, Mathiak K. Self-regulation of local brain activity using real-time functional magnetic resonance imaging (fMRI). J Physiol Paris. 2004 Jul-Nov;98(4-6):357-73. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proof of concept for using NF in anxious adolescents	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.	12 months	No
Secondary	Improved emotion regulation skills (questionnaires, behavioural tasks)	Significant change in questionnaire scores	12 months	No
Secondary	Successful reduction in anxious mood (questionnaire)	Significant reduction in anxiety scores	12 months	No
Secondary	Demographics (Demographic questionnaire)	General assessment	12 months	No
Secondary	Thought control abilities (questionnaire)	General assessment	12 months	No
Secondary	IQ levels (Wechsler Abbreviated Intelligence Scale)	General assessment	12 months	No
Secondary	Emotion regulation skills (Cognitive Emotion Regulation Questionnaire)	General assessment	12 months	No
Secondary	Mood and feelings (Moods and feelings questionnaire)	General assessment	12 months	Yes
Secondary	Debriefing interview questionnaire	General assessment	12 months	No