| Methods |
Design: three group parallel trial
Purpose: examine the effect of psycho‐social intervention on recurrence of genital herpes simplex |
| Participants |
Patients: media and healthcare‐referred persons with recurrent genital herpes simplex with 4 or more attacks a year
Baseline comparability: yes |
| Interventions |
Placebo:
‐sessions of social support consisting of discussions of interpersonal conflicts without any relaxation techniques or stress management.
Untreated: no sessions (waiting‐list)
Experimental: sessions of relaxation techniques and stress management + playing a relaxation tape during herpes attacks
(Co‐intervention: NS) |
| Outcomes |
Herpes attack: severity (index)
Herpes attack: frequency and duration
Zung Depression Scale
Profile of Mood States
UCLA Loneliness Scale
Multidimensional Health Locus of Control Scales |
| 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/psycho‐social intervention) |
| 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? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 19 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
