Methods |
Design: three group parallel trial
Purpose: examine the effect of aversive stimulation (self‐administered electric shocks) on hallucinatious schizophrenic patients |
Participants |
Patients: schizophrenic in‐patients (men) with auditory hallucinations
Baseline comparability: yes |
Interventions |
Placebo: patients equipped with a device that did not produce an electric shock and instructed to activate it when hallucinating (told that some people could not feel the shock)
Untreated: not equipped with a device to induce electric shock
Experimental: equipped with a device that did produce an electric shock and instructed to activate it when hallucinating
(Co‐intervention:
‐medication (type and dose NS, four patients changed)
‐other experimental intervention (type NS, interference deemed implausible by authors)
‐group and milieu therapy (type, frequency NS)) |
Outcomes |
Brief Psychiatric Rating Scale: hallucination scale
Patient Data Sheet
Symptom checklist
Ward personnel comments |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/electric shock) |
Incomplete outcome data addressed?
All outcomes |
High risk |
|
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 (not naturally positive continuous outcomes e.g. change) |
Trial size > 49? |
High risk |
N = 30 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |