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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pei-Shan Tsai, National Science Council, Taiwan
ClinicalTrials.gov Identifier:
NCT01044563
First received: December 31, 2009
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.

Condition Intervention
Postmenopause
Behavioral: Breathing training
Behavioral: Stress management

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

Further study details as provided by National Science Council, Taiwan:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: posttest (8 weeks from baseline) ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: follow-up (16 weeks from baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate variability (Resting, reactivity to stress, and recovery from stress) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Heart rate variability (Resting, reactivity to stress, and recovery from stress) [ Time Frame: posttest (8 weeks from baseline) ] [ Designated as safety issue: No ]
  • Heart rate variability (Resting, reactivity to stress, and recovery from stress) [ Time Frame: follow-up (16 weeks from baseline) ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044563

Locations
Taiwan
Taipei Medical University
Taipei, Xinyi Dist., Taiwan, 110
Sponsors and Collaborators
National Science Council, Taiwan
  More Information

No publications provided

Responsible Party: Pei-Shan Tsai, Professor, College of Nursing, Taipei Medical University, National Science Council, Taiwan
ClinicalTrials.gov Identifier: NCT01044563     History of Changes
Other Study ID Numbers: NSC98-2629-B-038-002-MY3-TMU
Study First Received: December 31, 2009
Last Updated: September 25, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Science Council, Taiwan:
Depression
Depressive Symptoms
postmenopause
RSA biofeedback

ClinicalTrials.gov processed this record on October 23, 2014