Specialised CBT-based stepped care vs usual care (largest CBT trial)

Record details

Authors: Cima RFF, Maes IH, Joore MA, et al.
Journal / source: The Lancet (2012)
Design: RCT, assessor-masked; stepped multidisciplinary CBT-based care vs usual care; NCT00733044
Sample: 492 randomized (245 specialised / 247 usual care)
Primary endpoint: Three co-primaries over 12 months: HUI (quality of life), TQ (severity), THI (impairment)
Randomized: Yes · Sham/placebo-controlled: No · Independent of the manufacturer: Yes

What this research found

All three primary outcomes favored specialised care over 12 months: HUI +0.059 [0.025, 0.094] (d=0.24, p=0.0009); TQ −8.06 [−10.83, −5.30] (d=0.43, p<0.0001); THI −7.51 [−10.66, −4.35] (d=0.45, p<0.0001). Effective across severity strata; no adverse events.

The foundational trial behind guideline recommendations for CBT-based tinnitus care. Distress/QoL outcomes — no loudness endpoint. Funded by ZonMW (Netherlands).

Limitations and conflicts of interest

Usual-care comparator (not attention-matched); single country.

Funding / conflicts: Independent (public funding).

Primary sources

Used as evidence for

Cognitive Behavioral Therapy (CBT)

This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.