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

NCT03948269 | Unknown DMC

• 1 other identifier: Southeast Menopausal Protocol
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

menopause; group treatment; mood swing; quality of life

Outcome Measures

Primary Outcomes (3)

• Greene Climacteric Scale

  Greene Climacteric Scale is used for evaluating menopausal symptoms. It contains 21 questions covering 5 domains: anxiety, depression, somatic symptoms, vasomotor symptoms, and sexual function. Each question is answered on a 4-point Likert scale. The answers to all 21 questions are summed to give a total quality-of-life measure; a higher score indicates a worse quality of life. According to the hypothesis and PRO-specific domains of this trial, vasomotor symptoms, anxiety and depression will be analysed specifically. The Chinese version of this questionnaire has a high validation (0.90), and the Cronbach's alpha coefficient is 0.95, while its test-retest reliability is 0.94 (P \<0.01).

  week 0

• Greene Climacteric Scale

  Menopause symptoms after 10 sessions of group cognitive behavioral therapy

  week 10

• Greene Climacteric Scale

  Menopause symptoms of one follow-up meeting

  week 22

Secondary Outcomes (12)

• The Short Form 36 Health Survey Questionnaire

  week 0

• The Short Form 36 Health Survey Questionnaire

  week 10

• The Short Form 36 Health Survey Questionnaire

  week 22

• Pittsburgh Sleep Quality Index

  week 0

• Pittsburgh Sleep Quality Index

  week 10

Study Arms (2)

Internet- and mobile-based group treatment

EXPERIMENTAL

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.

Behavioral: group behavioral cognitive therapy

Face-to-face group treatment

ACTIVE COMPARATOR

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

Behavioral: group behavioral cognitive therapy

Interventions

group behavioral cognitive therapy 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; Internet- and mobile-based group treatment

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead
• The Affiliated Obstetrics and Gynecology Hospital of Nanjing Medical University: collaborator

Study Sites (1)

the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Study Officials

• Jing Ms Kong, Master

  the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Mixed-effects models (random intercept) with interaction effects of group and time will be conducted on primary and secondary repeating outcomes.

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: June 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: August 31, 2020
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

CN (1)