PostmenopauseNCT01046149
Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-2
A study testing Breathing training and Stress management in people with Postmenopause, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial summary
The specific aims of this study are: 1. To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms, 2. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- Breathing training and Stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2010to not given
- 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 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent termination of menstruation of natural cause.
- Cessation of menstrual cycles for more than 12 consecutive months.
- A score of the Chinese version of Beck Depression Inventory-II of greater than 10.
- Able to speak Mandarin or Taiwanese.
- Age from 45 to 64 years.
Who cannot join
- Subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency.
- Subjects who received hormone replacement therapy prescribed by gynecological physicians.
- Subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions
Trial locations and contacts
1 site in 1 country.
About this study
The specific aims of this study are:
- To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms,
- To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms,
- To examine the intermediate-term effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms, and
- To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.
Read the detailed description
Postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. They are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. We expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.
- Conditions
- Postmenopause
- Being tested
- Breathing training, Stress management
- Keywords
- Depression, Depressive Symptoms, postmenopause, RSA biofeedback
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing trainingBehavioural
Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
Stress managementBehavioural
Cognitive reconstructive strategies for stress management
| Study group | Role | What they receive |
|---|---|---|
| Breathing training | Experimental | Respiratory sinus arrhythmia biofeedback-assisted deep breathing training Receives: Behavioral: Breathing training |
| Stress management | Active comparator | Cognitive reconstructive strategies for stress management Receives: Behavioral: Stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured: baseline
Depressive symptoms
Measured: posttest (8 weeks from baseline)
Depressive symptoms
Measured: follow-up (16 weeks from baseline)
Secondary outcomes (3)
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Measured: baseline
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Measured: posttest (8 weeks from baseline)
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Measured: follow-up (16 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startFeb 2010
Why it stopped: No participants were recruited at this study site. Study has been conducted and monitored at ClinicalTrials.gov ID: NCT01044563.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pei-Shan Tsai, National Science and Technology Council, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046149
- Sponsor's protocol ID
- NSC98-2629-B-038-002-MY3-TMUH
- Status last verified
- Sep 2014
- First submitted
- 7 Jan 2010
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-2
- ClinicalTrials.gov ID
- NCT01046149
- Acronym / sponsor ID
- NSC98-2629-B-038-002-MY3-TMUH
- Conditions
- Postmenopause
- Keywords
- Depression, Depressive Symptoms, postmenopause, RSA biofeedback
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were recruited at this study site. Study has been conducted and monitored at ClinicalTrials.gov ID: NCT01044563.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- Feb 2010
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims of this study are:
- To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms,
- To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms,
- To examine the intermediate-term effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms, and
- To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.
Detailed description
Postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. They are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. We expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing training | Experimental | Behavioral: Breathing trainingRespiratory sinus arrhythmia biofeedback-assisted deep breathing training |
| Stress management | Active comparator | Behavioral: Stress managementCognitive reconstructive strategies for stress management |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Permanent termination of menstruation of natural cause.
- Cessation of menstrual cycles for more than 12 consecutive months.
- A score of the Chinese version of Beck Depression Inventory-II of greater than 10.
- Able to speak Mandarin or Taiwanese.
- Age from 45 to 64 years.
Key exclusion criteria (3 listed)
- Subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency.
- Subjects who received hormone replacement therapy prescribed by gynecological physicians.
- Subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing trainingRespiratory sinus arrhythmia biofeedback-assisted deep breathing training | Behavioural | Breathing training |
| Stress managementCognitive reconstructive strategies for stress management | Behavioural | Stress management |
Primary outcome
Depressive symptoms
Time frame: baseline
Depressive symptoms
Time frame: posttest (8 weeks from baseline)
Depressive symptoms
Time frame: follow-up (16 weeks from baseline)
3 secondary outcomes
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time frame: baseline
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time frame: posttest (8 weeks from baseline)
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time frame: follow-up (16 weeks from baseline)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing training and Stress management in people with Postmenopause, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Sep 2014. 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 Taiwan. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Depressive symptoms (time frame: baseline). 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?
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 26 Sep 2014.