Table 1.
Overview of the planned analyses to address the objectives of the UNITI-RCT
| Objective | Description of comparison | Contrasted groups | Primary outcome | Secondary outcome | |||||
|---|---|---|---|---|---|---|---|---|---|
| 1 | Single versus combined |
(CBT, ST, SC, HA) versus (CBT + HA, CBT + ST, CBT + SC, ST + HA, ST + SC, SC + HA) |
THI | CGI-I | TFI | Mini TQ | NRS | WHO-QoL Bref | PHQ-9 |
| 2 | All ten treatment arms |
CBT, ST, SC, HA, CBT + HA, CBT + ST, CBT + SC, ST + HA, ST + SC, SC + HA versus each other |
|||||||
| 3 | SC single versus combined | SC versus (SC + CBT, SC + ST, SC + HA) | |||||||
| ST single versus combined | ST versus (ST + SC, ST + CBT, ST + HA) | ||||||||
| HA single versus combineda | HA versus (HA + SC, HA + CBT, HA + ST) | ||||||||
| CBT single versus combined | CBT versus (CBT + SC, CBT + ST, CBT + HA) | ||||||||
| 4 | SC versus no SC |
(SC, CBT + SC, ST + SC, SC + HA) versus (CBT, ST, HA, CBT + HA, CBT + ST, ST + HA) |
|||||||
| ST versus no ST | (ST, CBT + ST, ST + HA, ST + SC) versus (CBT, SC, HA, CBT + HA, CBT + SC, SC + HA) | ||||||||
| HA versus no HAa |
(HA, CBT + HA, ST + HA, SC + HA) versus (CBT, ST, SC, CBT + ST, CBT + SC, ST + SC) |
||||||||
| CBT versus no CBT |
(CBT, CBT + HA, CBT + ST, CBT + SC) versus (ST, SC, HA, ST + HA, ST + SC, SC + HA) |
||||||||
| 5 | Combination of brain and ear targeting treatments versus ear or brain targeting treatments | (CBT + HA, CBT + ST, ST + SC, SC + HA) versus (CBT, SC, CBT + SC) versus (HA, ST, HA + ST) | |||||||
CBT cognitive behavior therapy, ST sound therapy, SC structured counseling, HA hearing aids
aOnly patients from the strata with HA indication are included in this analysis