Fmri-based Neurofeedback With Anxious Adolescents Study (NF-AA)

November 9, 2016 updated by: University of Oxford

Using Real-time fMRI-based Neurofeedback With Anxious Adolescents

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved emotion regulation skills (questionnaires, behavioural tasks)
Time Frame: 12 months
Significant change in questionnaire scores
12 months
Successful reduction in anxious mood (questionnaire)
Time Frame: 12 months
Significant reduction in anxiety scores
12 months
Demographics (Demographic questionnaire)
Time Frame: 12 months
General assessment
12 months
Thought control abilities (questionnaire)
Time Frame: 12 months
General assessment
12 months
IQ levels (Wechsler Abbreviated Intelligence Scale)
Time Frame: 12 months
General assessment
12 months
Emotion regulation skills (Cognitive Emotion Regulation Questionnaire)
Time Frame: 12 months
General assessment
12 months
Mood and feelings (Moods and feelings questionnaire)
Time Frame: 12 months
General assessment
12 months
Debriefing interview questionnaire
Time Frame: 12 months
General assessment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

King's College London
Cardiff University

Investigators

  • Principal Investigator: Kathrin ' Cohen Kadosh, PhD, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MSD-IDREC-C2-2013-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data may be shared across the Braintrain consortium

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe