Table 1 Overview of the planned analyses to address the objectives of the UNITI-RCT

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 combined^a

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 HA^a

(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)