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Completed

NCT Number: NCT02958176

Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

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).

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Key information

Conditions

Female Sexual Arousal Disorder

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Austin

Austin, Texas, 78751, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRV Biofeedback

Behavioral

At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap

Autogenic Training

Behavioral

Autogenic training recording provided on a CD

Primary outcomes

  1. Physiological sexual arousal assessed by vaginal photoplethysmography

    Time frame: One month

  2. Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)

    Time frame: One month

  3. Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)

    Time frame: Two months

Secondary outcomes

  1. Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)

    Time frame: Two months

  2. Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)

    Time frame: Two months

  3. Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)

    Time frame: Two months

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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