An interventional study of HRV Biofeedback and Autogenic Training in Female Sexual Arousal Disorder, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
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).
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.
115 studies on the registry are indexed under Sexual Dysfunction, Physiological; 46 are open to participants now.
This study's enrollment of 65 is close to the median of 60 across 80 interventional studies indexed under Sexual Dysfunction, Physiological.
Browse Sexual Dysfunction, Physiological studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At home HRV biofeedback using mobile device
Behavioral: HRV Biofeedback
At home HRV biofeedback using mobile device plus autogenic training recording
Behavioral: HRV Biofeedback · Behavioral: Autogenic Training
Wait list control
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
Autogenic training recording provided on a CD
Physiological sexual arousal assessed by vaginal photoplethysmography
Time frame: One month
Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)
Time frame: One month
Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)
Time frame: Two months
Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)
Time frame: Two months
Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)
Time frame: Two months
Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)
Time frame: Two months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sexual Dysfunction, Physiological→
University of Texas at Austin