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

ISRCTN ISRCTN49540320
DOI https://doi.org/10.1186/ISRCTN49540320
Secondary identifying numbers N/A
Submission date
10/03/2006
Registration date
08/05/2006
Last edited
09/08/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Simon Fleminger
Scientific

Consultant Neuropsychiatrist
Lishman Brain Injury Unit
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA pilot study of cognitive behavioural therapy for persistent post-concussional symptoms
Study objectivesTo 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(s)Institute of Psychiatry/South London and Maudsley Ethics Committee, ref: 311/02
Health condition(s) or problem(s) studiedPostconcussional syndrome
InterventionParticipants 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/01/2003
Completion date31/07/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/01/2003
Date of final enrolment31/07/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Maudsley Hospital
London
SE5 8AZ
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Email g.dale@iop.kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2016 Yes No

Editorial Notes

09/08/2016: Publication reference added.