The Effect of Internet- and Mobile-based Group Treatment in Menopausal Women

NCT ID: NCT03948269

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-08-31

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.

Conditions

Menopausal Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet- and mobile-based group treatment

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.

Group Type: EXPERIMENTAL

group behavioral cognitive therapy

Intervention Type: BEHAVIORAL

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. Table 1 summarizes the module topics and provides detailed information on the treatment program. All modules will be saved for repeated viewing after completion. Second, we will establish another WeChat program named Punched-in which participants report on aspects of their everyday life such as diet, sports, readings or mood, according to the plan made by psychiatrists, via text, audio, photo or video message. This program will only be visible to and able to be commented on by participants and psychiatrists.

Face-to-face group treatment

10 modules will be conducted every weekend in the psychological counseling room of The Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University.

Group Type: ACTIVE_COMPARATOR

group behavioral cognitive therapy

Intervention Type: BEHAVIORAL

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. Table 1 summarizes the module topics and provides detailed information on the treatment program. All modules will be saved for repeated viewing after completion. Second, we will establish another WeChat program named Punched-in which participants report on aspects of their everyday life such as diet, sports, readings or mood, according to the plan made by psychiatrists, via text, audio, photo or video message. This program will only be visible to and able to be commented on by participants and psychiatrists.

Interventions

group behavioral cognitive therapy

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. Table 1 summarizes the module topics and provides detailed information on the treatment program. All modules will be saved for repeated viewing after completion. Second, we will establish another WeChat program named Punched-in which participants report on aspects of their everyday life such as diet, sports, readings or mood, according to the plan made by psychiatrists, via text, audio, photo or video message. This program will only be visible to and able to be commented on by participants and psychiatrists.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Obstetrics and Gynecology Hospital of Nanjing Medical University

UNKNOWN

Sponsor Role: collaborator

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Dan Li

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Ms Kong, Master

Role: PRINCIPAL_INVESTIGATOR

the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University

Locations

the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

Southeast Menopausal Protocol

Identifier Type: -

Identifier Source: org_study_id