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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49540320
Enrollment
40
Registered
2006-05-08
Start date
2003-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postconcussional syndrome Mental and Behavioural Disorders Postconcussional syndrome

Interventions

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

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026