Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 31, 2009
September 25, 2014
May 2010
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
Depressive symptoms [ Time Frame: baseline, posttest, follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01044563 on ClinicalTrials.gov Archive Site
  • 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 ]
Heart rate variability (Resting, reactivity to stress, and recovery from stress) [ Time Frame: baseline, posttest, follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postmenopause
  • Behavioral: Breathing training
    Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
  • Behavioral: Stress management
    Cognitive reconstructive strategies for stress management
  • Experimental: Breathing training
    Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
    Intervention: Behavioral: Breathing training
  • Active Comparator: Stress management
    Cognitive reconstructive strategies for stress management
    Intervention: Behavioral: Stress management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
May 2012
August 2010   (final data collection date for primary outcome measure)

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
Female
45 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01044563
NSC98-2629-B-038-002-MY3-TMU
Yes
Pei-Shan Tsai, National Science Council, Taiwan
National Science Council, Taiwan
Not Provided
Not Provided
National Science Council, Taiwan
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP