A pilot study of cognitive behavioural therapy for persistent post-concussional symptoms
- Conditions
- Postconcussional syndromeMental and Behavioural Disorders
- Registration Number
- ISRCTN49540320
- Lead Sponsor
- King's College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Post-concussional symptoms, as assessed using the Rivermead Post Concussion Symptoms Questionnaire (RPQ; King, Crawford, Wenden et al., 1995)<br>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
Name Time Method 1. Symptoms of anxiety and depression (The Hospital Anxiety and Depression Scales [HADS]; Zigmond and Snaith, 1983)<br>2. Symptoms associated with PTSD (The Impact of Events Scale - Revised [IES-R]; Weiss and Marmar, 1997)<br>3. Fatigue (Checklist of Individual Strength [CIS20R]; Vercoulen, Swaninck, Fennis, Galama, Van Der Meer and Bleyenberg, 1994)<br>4. Pain (McGill Pain Questionnaire: Melzack, 1975)<br>5. Anger (State-Trait Anger Expression Inventory 2 [STAXI 2]; Spielberger, 1999)<br>6. An additional Quality of Life measure (Visual analogue scale from EQ-5D: Rabin and de Charro, 2001)