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

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.

Study Overview

• Status: Withdrawn
• Conditions: Postmenopause
• Intervention / Treatment: Behavioral: Breathing training; Behavioral: Stress management

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Xinyi Dist.
    • Taipei, Xinyi Dist., Taiwan, 110
      • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breathing training; Respiratory sinus arrhythmia biofeedback-assisted deep breathing training	Behavioral: Breathing training; Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
Active Comparator: Stress management; Cognitive reconstructive strategies for stress management	Behavioral: Stress management; Cognitive reconstructive strategies for stress management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depressive symptoms	baseline
Depressive symptoms	posttest (8 weeks from baseline)
Depressive symptoms	follow-up (16 weeks from baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate variability (Resting, reactivity to stress, and recovery from stress)	baseline
Heart rate variability (Resting, reactivity to stress, and recovery from stress)	posttest (8 weeks from baseline)
Heart rate variability (Resting, reactivity to stress, and recovery from stress)	follow-up (16 weeks from baseline)

Collaborators and Investigators

• Sponsor: National Science Council, Taiwan

Study record dates

Study Major Dates

• Study Start: February 1, 2010

Study Registration Dates

• First Submitted: January 7, 2010
• First Submitted That Met QC Criteria: January 8, 2010
• First Posted (Estimate): January 11, 2010

Study Record Updates

• Last Update Posted (Estimate): September 26, 2014
• Last Update Submitted That Met QC Criteria: September 25, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Depression; postmenopause; Depressive Symptoms; RSA biofeedback
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NSC98-2629-B-038-002-MY3-TMUH