Methods |
Design: three group parallel trial
Purpose: examine the effect of unguided self‐help for bulimia nervosa |
Participants |
Patients: patients with bulimia nervosa
Baseline comparability: yes (age, duration of bulimia nervosa) |
Interventions |
Placebo: cognitive behaviour self‐help therapy
Untreated: no self‐help therapy
Experimental: non‐specific self‐help therapy (manual on 'self‐assertion for women' and hearing a plausible rationale)
(Co‐intervention: NS) |
Outcomes |
Frequency of binge eating
Frequency of compensatory behaviours
Eating disorder inventory scores
Rosenberg self‐esteem score
Beck depression inventory score
Inventory of interpersonal problems score |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
'Random numbers table' |
Allocation concealment? |
Low risk |
'numbered opaque sealed envelopes' |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/self‐guide) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
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? |
Low risk |
N = 57 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |