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Menopausal SyndromeIMGTMPNCT03948269

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

A study testing group behavioral cognitive therapy in people with Menopausal Syndrome, run by Southeast University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menopausal Syndrome
What is being tested?
group behavioral cognitive therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
1 Jun 2018to 31 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

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

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.

Read more

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.

Being tested
group behavioral cognitive therapy
Keywords
menopause, group treatment, mood swing, quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • group behavioral cognitive therapyBehavioural

    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.

Study groups in NCT03948269
Study groupRoleWhat they receive
Internet- and mobile-based group treatmentExperimentalthe 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.
Receives: Behavioral: group behavioral cognitive therapy
Face-to-face group treatmentActive comparator10 modules will be conducted every weekend in the psychological counseling room of The Affiliated Obstetrics and Gynaecology Hospital of Nanjing Medical University.
Receives: Behavioral: group behavioral cognitive therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: week 0

  2. Greene Climacteric Scale

    Menopause symptoms after 10 sessions of group cognitive behavioral therapy

    Measured: week 10

  3. Greene Climacteric Scale

    Menopause symptoms of one follow-up meeting

    Measured: week 22

Secondary outcomes (12)

  1. The Short Form 36 Health Survey Questionnaire

    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%.

    Measured: week 0

  2. The Short Form 36 Health Survey Questionnaire

    Quality of life

    Measured: week 10

  3. The Short Form 36 Health Survey Questionnaire

    Quality of life

    Measured: week 22

  4. Pittsburgh Sleep Quality Index

    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)

    Measured: week 0

  5. Pittsburgh Sleep Quality Index

    Insomnia

    Measured: week 10

  6. Pittsburgh Sleep Quality Index

    Insomnia

    Measured: week 22

  7. The Hamilton Anxiety Rating Scale

    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.

    Measured: week 0, 10, 22

  8. The Hamilton Anxiety Rating Scale

    Anxiety

    Measured: week 10

  9. The Hamilton Anxiety Rating Scale

    Anxiety

    Measured: week 22

  10. The Working Alliance Inventory-Short Revised

    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").

    Measured: week 0, 10

  11. The Working Alliance Inventory-Short Revised

    Therapeutic alliance

    Measured: week 10

  12. Client Satisfaction Qestionnaire-8 (CSQ-8)

    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).

    Measured: week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2019
  2. Study start1 Jun 2018
  3. Primary completion31 Mar 2020 (estimated)
  4. Study completion31 Aug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03948269
Sponsor's protocol ID
Southeast Menopausal Protocol
Acronym
IMGTMP
Status last verified
May 2019
First submitted
9 May 2019
Last updated
14 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing group behavioral cognitive therapy in people with Menopausal Syndrome, run by Southeast University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Greene Climacteric Scale (time frame: week 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03948269.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.

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