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OpenTrials
Completed

NCT Number: NCT01044563

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

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.

Completed

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Key information

Age range

45 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, Xinyi Dist., 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breathing training

Behavioral

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Stress Management

Behavioral

Cognitive reconstructive strategies for stress management

Primary outcomes

  1. Depressive symptoms

    Time frame: baseline

  2. Depressive symptoms

    Time frame: posttest (8 weeks from baseline)

  3. Depressive symptoms

    Time frame: follow-up (16 weeks from baseline)

Secondary outcomes

  1. Heart rate variability (Resting, reactivity to stress, and recovery from stress)

    Time frame: baseline

  2. Heart rate variability (Resting, reactivity to stress, and recovery from stress)

    Time frame: posttest (8 weeks from baseline)

  3. Heart rate variability (Resting, reactivity to stress, and recovery from stress)

    Time frame: follow-up (16 weeks from baseline)

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Jan 8, 2010
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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