Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pilot study of cognitive behavioural therapy for persistent post-concussional symptoms
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Postconcussional syndrome
Intervention
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
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
01/01/2003
Overall trial end date
31/07/2007
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
40
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
01/01/2003
Recruitment end date
31/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Maudsley Hospital
London
SE5 8AZ
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
-
g.dale@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
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
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
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27496149