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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01045811

Enrollment

Registered

2010-01-11

Start date

2010-05-31

Completion date

Unknown

Last updated

2014-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopause

Keywords

Depression, Depressive Symptoms, postmenopause, RSA biofeedback

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.

Interventions

BEHAVIORALBreathing training

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

BEHAVIORALStress management

Cognitive reconstructive strategies for stress management

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Depressive symptoms	baseline

Secondary

Measure	Time frame
Heart rate variability (Resting, reactivity to stress, and recovery from stress)	baseline

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026