Clinical trial NCT01046149: Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-2
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postmenopause
Keywords: Depression
Depressive Symptoms
postmenopause
RSA biofeedback
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
First posted: 2010-01-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms,
3. 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
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: baseline
measure: Depressive symptoms
timeFrame: posttest (8 weeks from baseline)
measure: Depressive symptoms
timeFrame: follow-up (16 weeks from baseline)
Secondary outcomes:
measure: Heart rate variability (Resting, reactivity to stress, and recovery from stress)
timeFrame: baseline
measure: Heart rate variability (Resting, reactivity to stress, and recovery from stress)
timeFrame: posttest (8 weeks from baseline)
measure: Heart rate variability (Resting, reactivity to stress, and recovery from stress)
timeFrame: follow-up (16 weeks from baseline)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
state: Xinyi Dist.
Study officials:
References: