ISRCTN ISRCTN93159172
DOI https://doi.org/10.1186/ISRCTN93159172
Protocol serial number N/A
Sponsor Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder NHS Physical and Complex Disabilities National Research and Development Programme (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
19/10/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Thomas McMillan
Scientific

Department of Psychological Medicine
University of Glasgow
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Email t.m.mcmillan@clinmed.gla.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBrain injury
InterventionSubjects 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 typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/06/1998

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration110
Key inclusion criteriaClosed head injury patients
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1997
Date of final enrolment01/06/1998

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

Department of Psychological Medicine
Glasgow
G12 0XH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 22/09/2010 Yes No