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

Primary Purpose

Postmenopause

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Breathing training
Stress management
Sponsored by
National Science Council, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopause focused on measuring Depression, Depressive Symptoms, postmenopause, RSA biofeedback

Eligibility Criteria

45 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breathing training

Stress management

Arm Description

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Cognitive reconstructive strategies for stress management

Outcomes

Primary Outcome Measures

Depressive symptoms
Depressive symptoms
Depressive symptoms

Secondary Outcome Measures

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

Full Information

First Posted
December 31, 2009
Last Updated
September 25, 2014
Sponsor
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01044563
Brief Title
Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopause
Keywords
Depression, Depressive Symptoms, postmenopause, RSA biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing training
Arm Type
Experimental
Arm Description
Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
Arm Title
Stress management
Arm Type
Active Comparator
Arm Description
Cognitive reconstructive strategies for stress management
Intervention Type
Behavioral
Intervention Name(s)
Breathing training
Intervention Description
Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
Intervention Type
Behavioral
Intervention Name(s)
Stress management
Intervention Description
Cognitive reconstructive strategies for stress management
Primary Outcome Measure Information:
Title
Depressive symptoms
Time Frame
baseline
Title
Depressive symptoms
Time Frame
posttest (8 weeks from baseline)
Title
Depressive symptoms
Time Frame
follow-up (16 weeks from baseline)
Secondary Outcome Measure Information:
Title
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time Frame
baseline
Title
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time Frame
posttest (8 weeks from baseline)
Title
Heart rate variability (Resting, reactivity to stress, and recovery from stress)
Time Frame
follow-up (16 weeks from baseline)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
State/Province
Xinyi Dist.
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

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

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