Condition category
Mental and Behavioural Disorders
Date applied
19/07/2015
Date assigned
22/09/2015
Last edited
01/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a neurobiological condition (that is, a condition affecting the nervous system caused by a biological factor, for example genetics) that results in a number of behavioural symptoms including a short attention span, restlessness and acting on impulse. It can also cause sleeping problems and anxiety. The condition is most often seen in people with learning difficulties but can affect people of any intellectual ability. It can have a considerable effect on several areas of a sufferers life, leading to a relatively poor economic and social position within their population (lower socioeconomic status), less satisfaction with their employment and marriage and conditions such as depression and addiction. It is thought that 4.4% of adults have ADHD. However the nature of the disease and the best way to treat it are still not well understood; it is thought that the efficacy of pharmacological and/or therapeutic treatments is adversely affected by people refusing or not persisting with the treatment and has not been shown to last beyond 2 years. The aim of this study is to see whether neurofeedback (NFB) will result in better treatment outcomes for adults with ADHD.

Who can participate?
Adults diagnosed with ADHD and with a IQ score of more than 80.

What does the study involve?
Participants are randomly assigned to one of two groups. Those in group 1 (intervention group) are given 40 one-hour sessions of neurofeedback. Those in group 2 (waitlist group) also receive the sessions but only after the study is complete. All participants are asked to report on their own ADHD symptoms at the start of the study, one year after treatment and then 2.5 years after treatment. Attention span is also measured, using a computer test, at the beginning of the study and after treatment.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Mental Capital Care clinic, Helsinki (Finland)

When is the study starting and how long is it expected to run for?
October 2011 to June 2016

Who is funding the study?
Finnish Funding Agency for Innovation (Tekes)

Who is the main contact?
Dr Ben Cowley
ben.cowley@helsinki.fi

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ben Cowley

ORCID ID

http://orcid.org/0000-0001-8828-2994

Contact details

Työterveyslaitos
PL 40
Helsinki
00251
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

440078

Study information

Scientific title

Clinical trial of neurofeedback therapy intervention for finnish adult ADHD, with waiting list control and comparison of outcomes of pre- to post-treatment improvement on self-reported symptoms and computerised attention tests

Acronym

CENT

Study hypothesis

Attention Deficit/Hyperactivity Disorder (ADHD) is a common psychiatric disorder, with an estimated worldwide prevalence among children of around 5% (Polanczyc et al., 2007), and persistence into adolescence and adulthood estimated between 40-60% (Faraone et al., 2006); it is associated with a variety of problems such as poor socialization and academic performance, and the efficacy of pharmacological and/or therapeutic treatments is adversely affected by non-compliance or aversion and has not been shown to last beyond 2 years.

Principal hypothesis: application of neurofeedback will result in improved scores on self-report measures of ADHD, and computerised attention tests, compared to waiting list control.

Ethics approval

Helsingin ja Uudenmaan Sairaanhoitopiiri (english: Hospital District of Helsinki and Uusimaa), 28/03/2012, JulkL 621/1999, 24 §

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Attention Deficit/Hyperactivity Disorder (ADHD)

Intervention

After randomisation, the treatment group will be given 40 sessions of 1 hour per session of neurofeedback at the Mental Capital Care clinic in Helsinki. Baseline, post-treatment and follow-up measurements as described.

The control group will be tested at the same times as the treatment group. They will receive a computerised attention training intervention after the follow-up measurement.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Self-report of ADHD symptoms, using Brown Attention Deficit Disorder Scale (BADDS) to be measured at baseline, post-treatment 1 year after baseline, and follow-up 2.5 years after treatment
2. Adult ADHD Self Report Scale (ASRS) to be measured at the same timepoints as BADDS
3. Objective measure of attention, using the computerised Test Of Variables of Attention (TOVA), to be completed at baseline and post-treatment

Secondary outcome measures

Treatment group records of performance during neurofeedback ('learning curves').

Overall trial start date

01/10/2011

Overall trial end date

01/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pre-existing diagnosis of ADHD
2. Nonexistence of neurological diagnoses
3. IQ score > 80 measured by a qualified psychologist using WAIS IV
4. Scores on ASRS and BADDS indicating presence of ADHD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

55

Participant exclusion criteria

Extreme outlier scores in the scales of
1. Generalized Anxiety Disorder (Spitzer et al., 2006)
2. Beck Depression Inventory (Beck et al., 1996)
3. Alcohol Use Disorders Identification Test (Saunders et al., 1993)
4. The Mood Disorder Questionnaire (Robert et al., 2000)
5. Test of prodromal symptoms of psychosis (Heinimaa et al., 2003)
6. Dissociative experiences scale (Liebowitz, 1992) for dissociative symptoms

Thresholds for exclusion were not fixed but at the discretion of the consulting psychiatrist. Use of medication for ADHD was not an exclusion criterion but participants were asked not to make changes in medication during the time of the training.

Recruitment start date

01/04/2012

Recruitment end date

01/08/2012

Locations

Countries of recruitment

Finland

Trial participating centre

Mental Capital Care clinic
Malmi
Helsinki
00700
Finland

Sponsor information

Organisation

University of Helsinki

Sponsor details

Institute of Behavioural Sciences
PO Box 9
Helsinki
FI-00014
Finland
+358 (0)294 1911
ibs-info@helsinki.fi

Sponsor type

University/education

Website

http://www.helsinki.fi/ibs/index.htm

Funders

Funder type

Government

Funder name

Tekes

Alternative name(s)

Finnish Funding Agency for Innovation

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Finland

Results and Publications

Publication and dissemination plan

A journal publication is planned, titled:
Learning and Arousal: a Clinical Trial Report on a Novel Neurofeedback Design for Adult ADHD

A Master's thesis was completed describing some results of the initial treatment phase, titled:
A neurofeedback intervention study on adults with ADHD
by Edua Hölmström

Further publications are to be confirmed.

Intention to publish date

01/01/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27242472

Publication citations

Additional files

Editorial Notes

01/06/2016: Publication reference added.