| Methods |
Design: three group parallel trial
Purpose: examine the effect of cognitive‐behaviour therapy on psycho‐social problems and seizure control in epileptic patients |
| Participants |
Patients: epileptic out‐patients with psycho‐social problems (anxiety, depression) and inadequate seizure control
Baseline comparability: yes |
| Interventions |
Placebo: sessions of supportive group counselling or discussion with no specific cognitive‐behaviour therapy
Untreated: no sessions
Experimental: sessions of behavioural‐cognitive therapy
(Co‐intervention:
‐'professional counselling or psychiatric treatment' to all but 6 patients
‐anticonvulsant medication. The difference in serum‐level between the groups was not significant.) |
| Outcomes |
Number of patients with improvement in seizure frequency (frequency diary)
Seizure rating by blinded observer
Global rating of psycho‐social adjustment |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/behavioural cognitive training) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 19 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trials size < 49 |
