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WithdrawnNCT01045811Updated Sep 26, 2014

Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-3

An interventional study of Breathing training and Stress management in Postmenopause, sponsored by National Science Council, Taiwan. Withdrawn at 1 site in Taiwan. Open to female participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-26.

Sponsored by National Science Council, Taiwan · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No participants were recruited at this study site. Study has been conducted and monitored with ClinicalTrials.gov ID: NCT01044563.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
Female
01

Study summary

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.
Read the 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.

02

Conditions studied

  • Postmenopause

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Keywords

  • Depression
  • Depressive Symptoms
  • postmenopause
  • RSA biofeedback
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

Browse Depression studies →

Lead sponsor

National Science Council, Taiwan is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Breathing training

    Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

    Behavioral: Breathing training

  • Active comparator
    Stress management

    Cognitive reconstructive strategies for stress management

    Behavioral: Stress management

Interventions

  • BehavioralBreathing training

    Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

  • BehavioralStress management

    Cognitive reconstructive strategies for stress management

06

What researchers measure

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)

07

Study locations

1 site
  • Taipei Medical University Wangfang Hospital
    Taipei, Wenshan Dist. 116, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01045811
Lead sponsor
National Science Council, Taiwan
Responsible party
Pei-Shan Tsai (Professor, College of Nursing, Taipei Medical University, National Science Council, Taiwan) — Principal investigator
First posted
Jan 11, 2010
Start date
May 2010
Last update
Sep 26, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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