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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

National Science Council, Taiwan

ClinicalTrials.gov Identifier:

NCT01046149

First received: January 7, 2010

Last updated: June 22, 2011

Last verified: November 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 7, 2010
Last Updated Date	June 22, 2011
Start Date ^ICMJE	February 2010
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: January 8, 2010)	Depressive symptoms [ Time Frame: baseline, posttest (8 weeks), follow-up (16 weeks) ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01046149 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 8, 2010)	Heart rate variability (Resting, reactivity to stress, and recovery from stress) [ Time Frame: baseline, posttest (8 weeks), follow-up (16 weeks) ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-2
Official Title ^ICMJE	Not Provided
Brief Summary	The specific aims of this study are: To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms, To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms, 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 To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Postmenopause
Intervention ^ICMJE	Behavioral: Breathing training Respiratory sinus arrhythmia biofeedback-assisted deep breathing training Behavioral: Stress management Cognitive reconstructive strategies for stress management
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	120
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	45 Years to 64 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT01046149
Other Study ID Numbers ^ICMJE	NSC98-2629-B-038-002-MY3-TMUH
Has Data Monitoring Committee	Yes
Responsible Party	Pei-Shan Tsai, Taipei Medical University
Study Sponsor ^ICMJE	National Science Council, Taiwan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Science Council, Taiwan
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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