Cultural adaptation, expert validation, and mixed-methods pilot evaluation of a psychologically informed, audiologist-delivered, manualised intervention for tinnitus-related distress in Malaysia

Tinnitus disorder entails a significant psychological component, yet it is traditionally managed by audiologists. Due to a lack of specialist mental health providers capable of meeting tinnitus patients’ needs, interest is growing in audiologist-delivered, psychologically informed interventions, primarily in Western countries. While such approaches remain limited in low- and middle-income countries, this study aimed to culturally adapt a UK-developed intervention for Malaysian adults with tinnitus and evaluate its validity, preliminary outcomes, and acceptability. The study comprised three stages: (1) translation and cultural adaptation guided by established frameworks; (2) expert review by seven audiologists using face and content validity indices; and (3) a single-arm convergent mixed-methods pilot involving ten adults with chronic tinnitus. Participants received three individual sessions over approximately one month, delivered by a trained audiologist. Tinnitus Functional Index and Depression Anxiety Stress Scales-42 scores were assessed at baseline, post-intervention, and three-month follow-up. Missing outcomes were handled using baseline observation carried forward, with completer sensitivity analyses. Acceptability was explored among completers using semi-structured interviews guided by the Theoretical Framework of Acceptability. All face-validity items and 60 chapter-domain content-validity assessments achieved an index of 1.00. Six of ten participants completed the intervention and all follow-up assessments. In the all-enrolled analysis, mean Tinnitus Functional Index scores decreased from 59.50 at baseline to 40.20 post-intervention and 36.80 at follow-up, with a significant effect of time ( p = .011). Depression, anxiety, and stress scores did not change significantly. Among completers, acceptability ratings and qualitative feedback were generally favourable, although some participants described effort associated with practising intervention strategies. The four participants who discontinued provided no observed post-baseline outcome or acceptability data. The culturally adapted intervention demonstrated strong face and content validity, while the pilot showed preliminary favourable outcome patterns and acceptability among completers. However, the small single-arm sample, 40% discontinuation, and absence of acceptability data from participants who discontinued limit interpretation. These findings support further controlled feasibility evaluation of the adapted intervention in Malaysia.