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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.
Age
40 - 60 years
Sex
FEMALE
Healthy Volunteers
Yes
the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Start Date
June 1, 2018
Primary Completion Date
March 31, 2020
Completion Date
August 31, 2020
Last Updated
May 14, 2019
140
ESTIMATED participants
group behavioral cognitive therapy
BEHAVIORAL
Lead Sponsor
Southeast University, China
Collaborators
NCT06837714
NCT00694733
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT00933725