Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

October 10, 2018 updated by: University of Texas at Austin

Autonomic Imbalance and Female Sexual Arousal Disorder: The Identification of Heart Rate Variability Level as a Risk Factor and Treatment Target

Low resting heart rate variability (HRV) has been associated with sexual arousal problems and overall sexual dysfunction in women. Research has indicated that HRV biofeedback leads to increases in HRV as well as improvements in symptoms associated with several psychological disorders, some of which are comorbid with sexual arousal problems in women. Autogenic training also facilitates increases in HRV and was recently associated with acute increases in sexual arousal among sexually healthy women. The primary aim of the current study is to examine the efficacy of HRV biofeedback, with and without autogenic training, for the treatment of female sexual arousal disorder (FSAD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women who meet ICD-10-CM diagnostic criteria for FSAD will be recruited and randomized into one of three conditions, HRV biofeedback (n = 25), HRV biofeedback plus autogenic training (n = 25), or wait-list control (n = 15). All participants will complete a baseline assessment, during which their resting state HRV and vaginal pulse amplitude (VPA) will be measured. The participants in the two biofeedback conditions will receive training in HRV biofeedback from the experimenter, and they will be provided with the materials necessary to guide self-practice in HRV biofeedback at home. Participants in these two conditions will be instructed to engage in at-home HRV biofeedback (with or without autogenic training) at least 5 times over a period of two weeks, during which they will report levels of arousal in a sexual activity diary. Participants in the wait-list control condition will report levels of arousal in a sexual activity diary. After two weeks, participants in all three conditions will return to the laboratory, where their physiological and psychological sexual arousal will be measured. Over the next two weeks, participants in the two biofeedback conditions will be asked to complete 5 more self-guided biofeedback sessions along with the sexual activity diary. Participants in all three conditions will return to the lab for a final assessment to measure post-treatment HRV and VPA levels as well as psychological sexual arousal. To our knowledge, this study will be the first randomized controlled trial of HRV biofeedback in women with sexual arousal problems. If the intervention increases arousal in this population, this study may offer a promising cost-effective psychosocial treatment for women with sexual arousal problems.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78751
        • The University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal (18-40 years)
  • Fluent in English
  • Heterosexual or bisexual
  • Score of 26.55 or less on the Female Sexual Function Index (FSFI)
  • Current sexual arousal dysfunction
  • Ownership of an Elite HRV compatible device (recent iPhone, iPad, or Android)

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of or current sexually transmitted infections
  • History of major pelvic surgery
  • History of childhood sexual abuse
  • Currently taking androgens, estrogens, or other medical treatments to enhance sexual arousal
  • Current psychosis
  • If on antidepressants or antihypertensives, must be stabilized for at least 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HRV Biofeedback
At home HRV biofeedback using mobile device
Behavioral: HRV Biofeedback
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
EXPERIMENTAL: HRV Biofeedback with Autogenic Training
At home HRV biofeedback using mobile device plus autogenic training recording
Behavioral: HRV Biofeedback
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
Behavioral: Autogenic Training
Autogenic training recording provided on a CD
NO_INTERVENTION: Wait List
Wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physiological sexual arousal assessed by vaginal photoplethysmography
Time Frame: One month
One month
Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)
Time Frame: One month
One month
Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)
Time Frame: Two months
Two months

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)
Time Frame: Two months
Two months
Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)
Time Frame: Two months
Two months
Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)
Time Frame: Two months
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Cindy M Meston, The University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (ESTIMATE)

November 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-08-0074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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