| Methods |
Design: five group parallel trial
Purpose: examine the effect of auditory masking and group cognitive therapy on tinnitus |
| Participants |
Patients: out‐patients suffering from tinnitus
Baseline comparability: yes (outcome variables) |
| Interventions |
Placebo: auditory masking with noise at hearing threshold
Untreated: no masking
Experimental:
‐auditory masking with variable noise level
‐group cognitive therapy
‐group cognitive therapy and auditory masking with variable noise level
(Co‐intervention: NS) |
| Outcomes |
Tinnitus Effects Questionnaire (insomnia, emotional distress, auditory perceptional difficulties)
Interference with daily activities
Crown Crisp Experimental Index |
| Notes |
Relevant outcome data not accessible: data lost (personal communication Jakes SC) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| 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? |
High risk |
Relevant outcome data not accessible: data lost (personal communication Jakes SC) |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 28 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
