Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas McMillan

ORCID ID

Contact details

Department of Psychological Medicine
University of Glasgow
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
t.m.mcmillan@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To determine whether home-based Attentional Control Training for closed head injury patients significantly reduces attentional problems and overall functional adjustment compared to a group receiving control exercise training procedure and to a group receiving no treatment at all.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Brain injury

Intervention

Subjects were randomly assigned to one of the following groups:
1. Received 5 sessions over a 4 week period of supervised practice of an Attentional Control Training tape and were asked to practice daily in the intervening period (n = 37)
2. Received an identical amount of therapist contact and also received tape-based training but based upon physical fitness training (n = 35)
3. Received no therapist contact but were assessed at the same intervals as the other 2 groups (n = 38)

The intervention was delivered in the participants own home. All patients were assessed at pre-treatment, post-training and 12 months follow-up by an assessor blind to the treatment group.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1997

Overall trial end date

01/06/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Closed head injury patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

110

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1997

Recruitment end date

01/06/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Physical and Complex Disabilities National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 results in http://www.mendeley.com/research/brief-mindfulness-training-attentional-problems-after-traumatic-brain-injury-randomised-control-treatment-trial/

Publication citations

Additional files

Editorial Notes