Group cognitive behavioural therapy of physical and psychological menopausal symptoms of Chinese women, delivered via Internet and mobile phone versus face to face: a protocol for a randomized non-inferiority trial

Abstract Background Menopause syndrome generally includes psychological problems. Group treatment delivered via the Internet and mobile phone (imGT) may improve women’s physiological and psychological conditions. Objective To investigate the efficacy of group cognitive behavioural therapy of menopause-related mood swings and quality of life, delivered face to face or via the Internet and mobile phone. Methods This protocol is for a randomized controlled clinical trial with a sample of 140 menopausal women divided into 2 groups: imGT and face-to-face group treatment (ffGT). The primary outcome will be the improvement in the menopausal symptoms of the two groups, as assessed by the Greene Climacteric Scale. The secondary outcomes will be: quality of life, assessed by the Short Form 36 Health Survey Questionnaire; insomnia, assessed by the Pittsburgh Sleep Quality Inventory; anxiety, assessed by the Hamilton Anxiety Rating Scale; and therapeutic alliance, assessed by the Working Alliance Inventory-Short Revised and Client Sat­is­fac­tion Qes­tion­naire-8. imGT will be performed once a week for 1.5 h for 10 weeks with a daily ‘Punched-in’ on the WeChat app; ffGT will be performed once a week for 1.5 h for 10 weeks. All outcomes will be assessed at baseline, at a post-intervention evaluation (week 10), and at a follow-up evaluation (week 22). Discussion This study will be the first clinical trial to examine the effects of imGT on menopausal women in China. If imGT is found to be non-inferior to ffGT, it will facilitate access to menopausal health services.