Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

Female Sexual Arousal Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958176
• Other study ID #: 2016-08-0074
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2018
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Female Sexual Arousal Disorder
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

Intervention

Behavioral:
• HRV Biofeedback
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
• Autogenic Training
Autogenic training recording provided on a CD

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological sexual arousal assessed by vaginal photoplethysmography		One month
Primary	Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)		One month
Primary	Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)		Two months
Secondary	Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)		Two months
Secondary	Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)		Two months
Secondary	Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)		Two months