Highlights
- •This article describes the protocol for a study of interventions to alleviate menopausal syndrome and its related mood swings.
- •The protocol sets out the rationale and methods for a trial of group cognitive behavioural therapy in menopausal women.
- •The aim is to evaluate the efficacy of group therapy delivered via the Internet or mobile phone and of face-to-face group treatment.
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.
Abbreviations:
imGT (group treatment delivered via the Internet and mobile phone), ffGT (face-to-face group treatment), GT (group treatment), CBT (cognitive behavioural therapy), QOL (quality of life)Keywords
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Article info
Publication history
Published online: August 13, 2019
Accepted:
August 12,
2019
Received in revised form:
June 5,
2019
Received:
May 5,
2019
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.