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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2002 results in http://www.mendeley.com/research/brief-mindfulness-training-attentional-problems-after-traumatic-brain-injury-randomised-control-treatment-trial/