Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Simon Fleminger


Contact details

Consultant Neuropsychiatrist
Lishman Brain Injury Unit
Maudsley Hospital
Denmark Hill
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A pilot study of cognitive behavioural therapy for persistent post-concussional symptoms


Study hypothesis

To determine the effectiveness of cognitive behavioural therapy (CBT) for individuals with persistent post-concussional symptoms after at least mild traumatic brain injury, in terms of post-concussional symptoms and quality of life.

Additional goals for the study include development of a treatment practice manual suitable for dissemination, and analysis of data to identify patient characteristics that may be related to differential treatment response.

Ethics approval

Institute of Psychiatry/South London and Maudsley Ethics Committee, ref: 311/02

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

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


Postconcussional syndrome


Participants will be randomly assigned to either:
1. Immediate Treatment:
Standard CBT. This will comprise of up to a dozen one-hour sessions of therapist contact, planned to be provided over a 3 - 4 month period. Treatment will also include provision of handouts explaining the features of PCS, identifying some of the factors considered to have a role in its development and maintenance over time, and suggested strategies for tackling symptoms.

2. Waiting List:
For 3 - 4 months. At the end of this period individuals will be offered a course of CBT identical to those provided in the 'immediate treatment' group.

Randomisation will utilise minimisation according to injury severity (based on post-traumatic amnesia), length of time since injury, site at which the individual is seen, and whether a medicolegal claim had or is being pursued.

Intervention type



Not Specified

Drug names

Primary outcome measures

1. Post-concussional symptoms, as assessed using the Rivermead Post Concussion Symptoms Questionnaire (RPQ; King, Crawford, Wenden et al., 1995)
2. Quality of life, assessed using the Brain Injury Community Rehabilitation Outcome Scale (Bicro-39; Powell, Beckers and Greenwood, 1998) and an individualised measure, the Quality of Life Assessment Schedule (QOLAS; Selai, Trimble, Rossor and Harvey, 2000)

Secondary outcome measures

1. Symptoms of anxiety and depression (The Hospital Anxiety and Depression Scales [HADS]; Zigmond and Snaith, 1983)
2. Symptoms associated with PTSD (The Impact of Events Scale - Revised [IES-R]; Weiss and Marmar, 1997)
3. Fatigue (Checklist of Individual Strength [CIS20R]; Vercoulen, Swaninck, Fennis, Galama, Van Der Meer and Bleyenberg, 1994)
4. Pain (McGill Pain Questionnaire: Melzack, 1975)
5. Anger (State-Trait Anger Expression Inventory 2 [STAXI 2]; Spielberger, 1999)
6. An additional Quality of Life measure (Visual analogue scale from EQ-5D: Rabin and de Charro, 2001)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Individuals aged between 18 and 65
2. Individuals who meet criteria for post-concussional disorder (ICD-10)
3. Individuals who have had a documented head trauma leading to a probable loss or alteration of consciousness, satisfying criteria for at least a mild brain injury (American Congress of Rehabilitation Medicine [ACRM] criteria)

These symptoms should have persisted for at least 6 months following the injury.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Individuals with severe cognitive impairment (defined in this study as Mini Mental State Exam scores of less than 20 and/or Frontal Assessment Battery scores of less than 10)
2. Individuals with moderate-severe physical disability (defined in this study as Barthel score less than 15). N.B. The Barthel activities of daily living (ADL) index will not be given as a matter of routine, but only if concerns regarding prominent physical disability are noted in one of the initial assessments.
3. Individuals who have had 4 or more sessions of CBT with a clinical or counselling psychologist, or cognitive-behavioural nurse therapist, subsequent to their head injury
4. Individuals who are not fluent in English
5. Presence of other neurological disorder independent of the head injury (e.g. non-post-traumatic epilepsy)
6. Presence of drug/alcohol misuse meeting International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10) criteria for a dependence syndrome (F1x.2), as specified in ICD-10. However, individuals who may be using drugs or alcohol to a lesser extent, to the point of harmful use (F1x.1) will not be excluded on this criterion.
7. Where the initial assessment indicated factors such as risk of self-harm or psychosis that would necessitate the involvement of a Community Mental Health Team

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Maudsley Hospital
United Kingdom

Sponsor information


King's College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
United Kingdom

Sponsor type




Funder type


Funder name

South London and Maudsley NHS Foundation Trust (UK) - Blackheath Brain Injury Rehabilitation Centre funding contract

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2016 results in:

Publication citations

Additional files

Editorial Notes

09/08/2016: Publication reference added.