Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

NCT ID: NCT02958176

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-01-31

Brief 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).

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.

Conditions

Female Sexual Arousal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HRV Biofeedback

At home HRV biofeedback using mobile device

Group Type: EXPERIMENTAL

HRV Biofeedback

Intervention Type: BEHAVIORAL

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

HRV Biofeedback with Autogenic Training

At home HRV biofeedback using mobile device plus autogenic training recording

Group Type: EXPERIMENTAL

HRV Biofeedback

Intervention Type: BEHAVIORAL

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

Autogenic Training

Intervention Type: BEHAVIORAL

Autogenic training recording provided on a CD

Wait List

Wait list control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HRV Biofeedback

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

Intervention Type: BEHAVIORAL

Autogenic Training

Autogenic training recording provided on a CD

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy M Meston

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Austin

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

2016-08-0074

Identifier Type: -

Identifier Source: org_study_id