Clinical trial NCT03948269: The Effect of Internet- and Mobile-based Group Treatment in Menopausal Women
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopausal Syndrome
Keywords: menopause
group treatment
mood swing
quality of life
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: The Affiliated Obstetrics and Gynecology Hospital of Nanjing Medical University
First posted: 2019-05-13
Enrollment: 140
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed-effects models (random intercept) with interaction effects of group and time will be conducted on primary and secondary repeating outcomes.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Greene Climacteric Scale
timeFrame: week 0
measure: Greene Climacteric Scale
timeFrame: week 10
measure: Greene Climacteric Scale
timeFrame: week 22
Secondary outcomes:
measure: The Short Form 36 Health Survey Questionnaire
timeFrame: week 0
measure: The Short Form 36 Health Survey Questionnaire
timeFrame: week 10
measure: The Short Form 36 Health Survey Questionnaire
timeFrame: week 22
measure: Pittsburgh Sleep Quality Index
timeFrame: week 0
measure: Pittsburgh Sleep Quality Index
timeFrame: week 10
measure: Pittsburgh Sleep Quality Index
timeFrame: week 22
measure: The Hamilton Anxiety Rating Scale
timeFrame: week 0, 10, 22
measure: The Hamilton Anxiety Rating Scale
timeFrame: week 10
measure: The Hamilton Anxiety Rating Scale
timeFrame: week 22
measure: The Working Alliance Inventory-Short Revised
timeFrame: week 0, 10
measure: The Working Alliance Inventory-Short Revised
timeFrame: week 10
measure: Client Satisfaction Qestionnaire-8 (CSQ-8)
timeFrame: week 10
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University
name: Jing Ms Kong, Master
role: PRINCIPAL_INVESTIGATOR
References: