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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948269
Recruitment Status : Enrolling by invitation
First Posted : May 13, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
The Affiliated Obstetrics and Gynecology Hospital of Nanjing Medical University
Information provided by (Responsible Party):
Dan Li, 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.


Condition or disease Intervention/treatment Phase
Menopausal Syndrome Behavioral: group behavioral cognitive therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mixed-effects models (random intercept) with interaction effects of group and time will be conducted on primary and secondary repeating outcomes.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Greene Climacteric Scale [ Time Frame: week 0 ]
    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).

  2. Greene Climacteric Scale [ Time Frame: week 10 ]
    Menopause symptoms after 10 sessions of group cognitive behavioral therapy

  3. Greene Climacteric Scale [ Time Frame: week 22 ]
    Menopause symptoms of one follow-up meeting


Secondary Outcome Measures :
  1. The Short Form 36 Health Survey Questionnaire [ Time Frame: week 0 ]
    The Short Form 36 Health Survey Questionnaire (SF36) is widely used for evaluating the potential benefits of healthcare interventions. It is comprised of eight dimensions (including physical functioning, social functioning, role limitations, mental health, energy/vitality, pain, general health perceptions), and the score ranges from 0 to 100, where better health achieves higher scores. This questionnaire was chosen because of the validation of the Chinese version with a sensitivity of 0.72~0.88 and specificity of 87.5%~100%.

  2. The Short Form 36 Health Survey Questionnaire [ Time Frame: week 10 ]
    Quality of life

  3. The Short Form 36 Health Survey Questionnaire [ Time Frame: week 22 ]
    Quality of life

  4. Pittsburgh Sleep Quality Index [ Time Frame: week 0 ]
    The Pittsburgh Sleep Quality Index (PSQI) is a self-rating inventory that evaluates sleep quality and disturbances within a 4-week time interval. It comprises 19 individual items with a global score ranging from 0 to 21. The correlation coefficient of PSQI for t-test reliability was 0.87. A Chinese PSQI score >7 yielded a sensitivity of 98.3% and specificity of 90.2% in distinguishing between good and poor sleepers (kappa= 0.89, p<0.01)

  5. Pittsburgh Sleep Quality Index [ Time Frame: week 10 ]
    Insomnia

  6. Pittsburgh Sleep Quality Index [ Time Frame: week 22 ]
    Insomnia

  7. The Hamilton Anxiety Rating Scale [ Time Frame: week 0, 10, 22 ]
    The Hamilton Anxiety Rating Scale (HAM-A) is a rating scale developed to measure the symptoms of anxiety neurosis. It is a semi-structured clinician-rated interview consisting of 14 items that measure both psychological anxiety and somatic anxiety. A 5-point scale ranging from 0 (not present) to 4 (severe) is used, where the total severity score is 0-56; <17 indicates mild anxiety and 25-30 is considered moderate-severe. The Chinese version of HAM-A will be used in this study.

  8. The Hamilton Anxiety Rating Scale [ Time Frame: week 10 ]
    Anxiety

  9. The Hamilton Anxiety Rating Scale [ Time Frame: week 22 ]
    Anxiety

  10. The Working Alliance Inventory-Short Revised [ Time Frame: week 0, 10 ]
    The Working Alliance Inventory-Short Revised (WAI-SR) provides an assessment of the therapeutic alliance and contains 12 items with three dimensions of working alliance: agreement on the tasks of therapy, agreement on the goals of therapy and development of an affective bond between client and therapist. Items are rated on a 5-point scale (range from 1= "never" to 5= "always").

  11. The Working Alliance Inventory-Short Revised [ Time Frame: week 10 ]
    Therapeutic alliance

  12. Client Satisfaction Qestionnaire-8 (CSQ-8) [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948269


Locations
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China, Jiangsu
the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Southeast University, China
The Affiliated Obstetrics and Gynecology Hospital of Nanjing Medical University
Investigators
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Principal Investigator: Jing Ms Kong, Master the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University
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Responsible Party: Dan Li, Principal investigator, Southeast University, China
ClinicalTrials.gov Identifier: NCT03948269    
Other Study ID Numbers: Southeast Menopausal Protocol
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Li, Southeast University, China:
menopause
group treatment
mood swing
quality of life