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

N

National Science Council, Taiwan

Status

Withdrawn

Conditions

Postmenopause

Treatments

Behavioral: Breathing training
Behavioral: Stress management

Study type

Interventional

Funder types

Other

Identifiers

NCT01045811
NSC98-2629-B-038-002-MY3-WFH

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

45 to 64 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups

Breathing training
Experimental group
Description:
Respiratory sinus arrhythmia biofeedback-assisted deep breathing training
Treatment:
Behavioral: Breathing training
Stress management
Active Comparator group
Description:
Cognitive reconstructive strategies for stress management
Treatment:
Behavioral: Stress management

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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