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

Postmenopause Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01046149
• Other study ID #: NSC98-2629-B-038-002-MY3-TMUH
• Status: Withdrawn
• Phase: N/A
• First received: January 7, 2010
• Last updated: September 25, 2014
• Start date: February 2010

Study information

• Verified date: September 2014
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

Behavioral:
• Breathing training
Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
• Stress management
Cognitive reconstructive strategies for stress management

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei	Xinyi Dist.

Sponsors (1)

Lead Sponsor	Collaborator
National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms		baseline	No
Primary	Depressive symptoms		posttest (8 weeks from baseline)	No
Primary	Depressive symptoms		follow-up (16 weeks from baseline)	No
Secondary	Heart rate variability (Resting, reactivity to stress, and recovery from stress)		baseline	No
Secondary	Heart rate variability (Resting, reactivity to stress, and recovery from stress)		posttest (8 weeks from baseline)	No
Secondary	Heart rate variability (Resting, reactivity to stress, and recovery from stress)		follow-up (16 weeks from baseline)	No