Menopausal Syndrome Clinical Trial
Official title:
Internet- and Mobile-based Group Treatment of Menopausal and Psychological Health of Chinese Women: a Study Protocol for a Randomized Non-inferiority Trial
Background: Menopause syndrome generally occurs with and is related to psychological
problems. However, Internet- and mobile-based group treatment (imGT) may improve women's
physiological and psychological conditions.
Objective: To investigate the efficacy of group treatment with or without Internet- and
mobile-based treatment of menopause, mood swings and quality of life status.
Methods: This protocol is for a randomized controlled clinical trial with a sample of 144
menopausal women divided into 2 groups: imGT and face-to-face group treatment (ffGT). The
primary outcome will be the menopausal symptom improvement of the two groups, as assessed by
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. imGT will be performed once a week
for 1.5 hours for 10 weeks with a daily Punched-in on the WeChat App; ffGT will be performed
once a week for 1.5 hours 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 equivalent to or superior to ffGT, it will
facilitate easier access to menopausal health services, which may be feasible to offer to
other medical institution.
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