Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Currently, traumatic brain injury patients with memory problems do not routinely receive rehabilitation after the early intensive treatment, even though their abilities and needs may change once they have left the hospital. This trial aims to investigate how effective a group-based memory rehabilitation programme is for military personnel and civilians who have sustained a traumatic brain injury.

Who can participate?
Men and women, civilians and military personnel, aged 18 to 69 years, more than 3 months since a traumatic brain injury.

What does the study involve?
Participants will be randomly allocated to receive either 10 group memory rehabilitation sessions or usual care, and will be followed up for 12 months.

What are the possible benefits and risks of participating?
We don’t know the exact benefits of the rehabilitation programme, but we hope that participants will benefit from it. The information we get from this study may help us to treat future patients with memory problems after a head injury better. There are no particular risks involved in taking part in this study. However, participants may be made aware of memory problems that they did not know they had. The Assistant Psychologist is trained to be able to help with this.

Where is the study run from?
Four centres, based in Birmingham, Nottingham, Surrey and Chester.

When is the study starting and how long is it expected to run for?
Recruitment will start in March 2013. Participants will be in the study for approximately 13 months. They will leave the study when they have completed the 12 month follow-up.

Who is funding the study?
National Institute for Health Research Health Technology Assessment Programme

Who is the main contact?
Roshan das Nair

Trial website

Contact information



Primary contact

Mrs Sandip Stapleton


Contact details

Nottingham University
Clinical Trials Unit
School of Community Health Sciences
Queens Medical Centre
Derby Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Rehabilitation of Memory following Traumatic Brain Injury – A Phase III Randomised Controlled Trial



Study hypothesis

Around 6 per cent of patients are admitted to Accident and Emergency departments in the UK as a result of a head injury. A study in the United States also found that 25 per cent of soldiers will experience a head injury during their army career. Following this type of injury a lot of these patients will find that they have long lasting problems with their memory affecting their life in a negative way. For example, some patients may not be able to return to work and notice that their memory problems have an effect on their social life and relationships. At the moment patients who have had a head injury are not always given any further therapy after they leave the hospital to help them deal with their memory problems. However, sometimes they find that their memory problems change or as their lifestyle changes.

Our aim is to compare a memory rehabilitation programme with current clinical care. We will assess the usefulness of memory rehabilitation in reducing problems with memory and in addition, how much it would cost to the NHS.

Ethics approval

East Midlands – Nottingham Research Ethics Committee, 21/09/2012, ref: 12/EM/0324

Study design

Randomised interventional trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Brain Injuries and Emergencies


Memory rehabilitation
The intervention will be offered in a group setting. Each group will be led by an Assistant Psychologist (AP) and consist of 4-6 participants. The APs at the different centres will be trained. Participants will receive 10 group memory rehabilitation sessions (1.5 hours long, once a week for 10 weeks), following a treatment manual which was developed and tested in the pilot study. Follow up length: 12 months.

Intervention type



Phase III

Drug names

Primary outcome measures

EMQ-p assessed at 6 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Were admitted to hospital with a TBI more than 3 months prior to recruitment
2. Report having memory problems as assessed at baseline
3. Are 18 to 69 years of age
4. Are able to travel to one of the study centres and attend group sessions
5. Give informed consent.
6. Male or female particpants

Participant type


Age group




Target number of participants

UK Sample Size: 312

Participant exclusion criteria

1. Unable or unsuitable to engage in group treatment if allocated
2. Are involved in other psychological intervention trials
3. Impairment of language, as assessed on the SST (cut-off score <17)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University
United Kingdom

Sponsor information


Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Queens Medical Centre
Derby Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

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

2015 protocol in:

Publication citations

Additional files

Editorial Notes