The Effect of Internet- and Mobile-based Group Treatment in Menopausal Women
- Conditions
- Menopausal Syndrome
- Interventions
- Behavioral: group behavioral cognitive therapy
- Registration Number
- NCT03948269
- Lead Sponsor
- Southeast University, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 140
- aged 40~60, in menopausal transition or post-menopause, according to the STRAW +10 definition
- have Internet access
- have mobile phone access
- have sufficient knowledge of the Chinese language
- have scored in the clinical range for menopause syndrome from the psychiatric interview
- have signed a consent form that will be provided to eligible participants.
- not completing informed consent
- presence of any of the following diseases: hyperthyroidism, coronary atherosclerotic heart disease, hypertension (BP≥140/90 mmHg), pheochromocytoma, neurasthenia, psychosis, or other diseases closely related to the main disease
- troublesome drinking
- drug use (hypnotics or hormone therapy) in the past 14 days, which might affect mood.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet- and mobile-based group treatment group behavioral cognitive therapy the therapy consists of 10 modules (15 hours in total) in groups of 8 participants each over a period of 10 weeks and one follow-up meeting (2 hours) 12 weeks after the 10th module (week 22). Each module is adapted from the previous literature on CBT rationale and will be conducted online on WeChat, a mobile social networking software with 1 billion users in 2018. First, we will establish a WeChat group containing the imGT group members and psychiatrists, in which everyone can talk instantly. The interactive treatments will be conducted every Friday evening for a duration of 1.5 hours via text, audio or video messaging. Face-to-face group treatment group behavioral cognitive therapy 10 modules will be conducted every weekend in the psychological counseling room of The Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University.
- Primary Outcome Measures
Name Time Method Greene Climacteric Scale week 22 Menopause symptoms of one follow-up meeting
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index week 22 Insomnia
Client Satisfaction Qestionnaire-8 (CSQ-8) week 10 Treatment satisfaction will be measured by the Client Satisfaction Qestionnaire-8 (CSQ-8), which evaluates the service utilization and psychotherapy outcome measures with high internal consistency (coefficient α = .91).
The Short Form 36 Health Survey Questionnaire week 22 Quality of life
The Hamilton Anxiety Rating Scale week 22 Anxiety
The Working Alliance Inventory-Short Revised week 10 Therapeutic alliance
Trial Locations
- Locations (1)
the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China