NCT02463136

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1 anxiety

Timeline
Completed

Started Nov 2015

Typical duration for phase_1 anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

1.9 years

First QC Date

May 22, 2015

Last Update Submit

November 9, 2016

Conditions

Anxiety

Keywords

AdolescenceBrain DevelopmentNeuroimagingNeurofeedbackAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Improved emotion regulation skills (questionnaires, behavioural tasks)

    12 months

  • Successful reduction in anxious mood (questionnaire)

    12 months

  • Demographics (Demographic questionnaire)

    12 months

  • Thought control abilities (questionnaire)

    12 months

  • IQ levels (Wechsler Abbreviated Intelligence Scale)

    12 months

  • +3 more secondary outcomes

Study Arms (1)

Behaviour and brain training

EXPERIMENTAL

fMRI-based neurofeedback

Behavioral: questionnairesDevice: Functional magnetic resonance imaging w neurofeedback

Interventions

questionnairesBEHAVIORAL

Clinical questionnaires and behavioural computer-based paradigms, such as the Overlap task (Cohen Kadosh et al., 2014)

Behaviour and brain training
Functional magnetic resonance imaging w neurofeedbackDEVICE

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).

Behaviour and brain training

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX1 3UD, United Kingdom

RECRUITING

Related Publications (10)

  • 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. Epub 2013 May 28.

    PMID: 23786475BACKGROUND

  • deCharms RC. Reading and controlling human brain activation using real-time functional magnetic resonance imaging. Trends Cogn Sci. 2007 Nov;11(11):473-81. doi: 10.1016/j.tics.2007.08.014. Epub 2007 Nov 7.

    PMID: 17988931BACKGROUND

  • 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. Epub 2015 Feb 28.

    PMID: 25818181BACKGROUND

  • 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. Epub 2013 Nov 9.

    PMID: 24220041BACKGROUND

  • 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.

    PMID: 22243743BACKGROUND

  • 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. Epub 2011 Oct 22.

    PMID: 22021045BACKGROUND

  • 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. doi: 10.1109/TBME.2004.827063.

    PMID: 15188865BACKGROUND

  • 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. doi: 10.1016/j.jphysparis.2005.09.019. Epub 2005 Nov 10.

    PMID: 16289548BACKGROUND

  • Haugg A, Renz FM, Nicholson AA, Lor C, Gotzendorfer SJ, Sladky R, Skouras S, McDonald A, Craddock C, Hellrung L, Kirschner M, Herdener M, Koush Y, Papoutsi M, Keynan J, Hendler T, Cohen Kadosh K, Zich C, Kohl SH, Hallschmid M, MacInnes J, Adcock RA, Dickerson KC, Chen NK, Young K, Bodurka J, Marxen M, Yao S, Becker B, Auer T, Schweizer R, Pamplona G, Lanius RA, Emmert K, Haller S, Van De Ville D, Kim DY, Lee JH, Marins T, Megumi F, Sorger B, Kamp T, Liew SL, Veit R, Spetter M, Weiskopf N, Scharnowski F, Steyrl D. Predictors of real-time fMRI neurofeedback performance and improvement - A machine learning mega-analysis. Neuroimage. 2021 Aug 15;237:118207. doi: 10.1016/j.neuroimage.2021.118207. Epub 2021 May 25.

    PMID: 34048901DERIVED

  • Zich C, Johnstone N, Luhrs M, Lisk S, Haller SP, Lipp A, Lau JY, Kadosh KC. Modulatory effects of dynamic fMRI-based neurofeedback on emotion regulation networks in adolescent females. Neuroimage. 2020 Oct 15;220:117053. doi: 10.1016/j.neuroimage.2020.117053. Epub 2020 Jun 20.

    PMID: 32574803DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kathrin ' Cohen Kadosh, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Cohen Kadosh, PhD

CONTACT

01865kathrin.cohenkadosh@psy.ox.ac.uk

Jennifer YF Lau, PhD

CONTACT

0207790j.lau@kcl.ac.uk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

June 4, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Data may be shared across the Braintrain consortium

Locations

GB(1)