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Clinical Trials/ISRCTN49540320
ISRCTN49540320
Completed
未知

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

King's College London (UK)0 sites40 target enrollmentMay 8, 2006

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
King's College London (UK)
Enrollment
40
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 8, 2006
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
King's College London (UK)

Eligibility Criteria

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.

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

Outcomes

Primary Outcomes

Not specified

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