Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder

NCT02958176 | Completed

• 1 other identifier: 2016-08-0074
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Female Sexual Arousal Disorder

Outcome Measures

Primary Outcomes (3)

• Physiological sexual arousal assessed by vaginal photoplethysmography

  One month

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

  One month

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

  Two months

Secondary Outcomes (3)

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

  Two months

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

  Two months

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

  Two months

Study Arms (3)

HRV Biofeedback

EXPERIMENTAL

At home HRV biofeedback using mobile device

Behavioral: HRV Biofeedback

HRV Biofeedback with Autogenic Training

EXPERIMENTAL

At home HRV biofeedback using mobile device plus autogenic training recording

Behavioral: HRV Biofeedback; Behavioral: Autogenic Training

Wait List

NO INTERVENTION

Wait list control

Interventions

HRV Biofeedback BEHAVIORAL

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

HRV Biofeedback; HRV Biofeedback with Autogenic Training

Autogenic Training BEHAVIORAL

Autogenic training recording provided on a CD

HRV Biofeedback with Autogenic Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78751, United States

Location

MeSH Terms

Interventions

Autogenic Training

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cindy M Meston

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 8, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

US (1)