Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-3

Study Overview
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Brief Summary
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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
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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
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Postmenopause

Intervention / Treatment
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* Behavioral: Breathing training
* Behavioral: Stress management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing training<br>Respiratory sinus arrhythmia biofeedback-assisted deep breathing training | Behavioral: Breathing training<br>* Respiratory sinus arrhythmia biofeedback-assisted deep breathing training<br>|
| Active Comparator: Stress management<br>Cognitive reconstructive strategies for stress management | Behavioral: Stress management<br>* Cognitive reconstructive strategies for stress management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms |  | baseline | 
| Depressive symptoms |  | posttest (8 weeks from baseline) | 
| Depressive symptoms |  | follow-up (16 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (Resting, reactivity to stress, and recovery from stress) |  | baseline | 
| Heart rate variability (Resting, reactivity to stress, and recovery from stress) |  | posttest (8 weeks from baseline) | 
| Heart rate variability (Resting, reactivity to stress, and recovery from stress) |  | follow-up (16 weeks from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Depressive Symptoms, postmenopause, RSA biofeedback