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

NCT01045811 | Withdrawn DMC

• 1 other identifier: NSC98-2629-B-038-002-MY3-WFH
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are:

1. 1.To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms,
2. 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. 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. 4.To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.

Conditions

Postmenopause

Keywords

Depression; Depressive Symptoms; postmenopause; RSA biofeedback

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

  baseline

• Depressive symptoms

  posttest (8 weeks from baseline)

• Depressive symptoms

  follow-up (16 weeks from baseline)

Secondary Outcomes (3)

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

  baseline

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

  posttest (8 weeks from baseline)

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

  follow-up (16 weeks from baseline)

Study Arms (2)

Breathing training

EXPERIMENTAL

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Behavioral: Breathing training

Stress management

ACTIVE COMPARATOR

Cognitive reconstructive strategies for stress management

Behavioral: Stress management

Interventions

Breathing training BEHAVIORAL

Respiratory sinus arrhythmia biofeedback-assisted deep breathing training

Breathing training

Stress management BEHAVIORAL

Cognitive reconstructive strategies for stress management

Stress management

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

Study Sites (1)

Taipei Medical University Wangfang Hospital

Taipei, Wenshan Dist., 116, Taiwan

Location

MeSH Terms

Conditions

Depression

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Nursing, Taipei Medical University

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 11, 2010
• Study Start: May 1, 2010
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

TW (1)