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

NCT03948269 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-05-14

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • The Affiliated Obstetrics and Gynecology Hospital of Nanjing Medical University

    collaborator UNKNOWN

  • Southeast University, China

    lead OTHER

Principal Investigators

  • Jing Ms Kong, Master · the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2020-03-31
Completion
2020-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948269 on ClinicalTrials.gov