Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-2

Not Applicable

Withdrawn

• Conditions: Postmenopause
• Interventions: Behavioral: Stress management; Behavioral: Breathing training

• Registration Number: NCT01046149
• Lead Sponsor: National Science Council, Taiwan

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.

Study Timeline

• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Study Start: 2010-02
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-25
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress management	Stress management	Cognitive reconstructive strategies for stress management
Breathing training	Breathing training	Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	follow-up (16 weeks from baseline)

Secondary Outcome Measures

Name	Time	Method
Heart rate variability (Resting, reactivity to stress, and recovery from stress)	follow-up (16 weeks from baseline)

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Xinyi Dist., Taiwan