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

NCT ID: NCT01046149

Last Updated: 2014-09-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28

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.

Conditions

Postmenopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Breathing training

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Group Type: EXPERIMENTAL

Breathing training

Intervention Type: BEHAVIORAL

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Stress management

Cognitive reconstructive strategies for stress management

Group Type: ACTIVE_COMPARATOR

Stress management

Intervention Type: BEHAVIORAL

Cognitive reconstructive strategies for stress management

Interventions

Breathing training

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Intervention Type: BEHAVIORAL

Stress management

Cognitive reconstructive strategies for stress management

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Pei-Shan Tsai

Professor, College of Nursing, Taipei Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Medical University Hospital

Taipei, Xinyi Dist., Taiwan

Countries

Taiwan

Other Identifiers

NSC98-2629-B-038-002-MY3-TMUH

Identifier Type: -

Identifier Source: org_study_id