Female Sexual Arousal DisorderNCT02958176
Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder
A study testing HRV Biofeedback and Autogenic Training in people with Female Sexual Arousal Disorder, run by University of Texas at Austin at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Female Sexual Arousal Disorder
- What is being tested?
- HRV Biofeedback and Autogenic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78751
About this study
Official title: Autonomic Imbalance and Female Sexual Arousal Disorder: The Identification of Heart Rate Variability Level as a Risk Factor and Treatment Target
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).
Read the 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
- Being tested
- HRV Biofeedback, Autogenic Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV BiofeedbackBehavioural
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
Autogenic TrainingBehavioural
Autogenic training recording provided on a CD
| Study group | Role | What they receive |
|---|---|---|
| HRV Biofeedback | Experimental | At home HRV biofeedback using mobile device Receives: Behavioral: HRV Biofeedback |
| HRV Biofeedback with Autogenic Training | Experimental | At home HRV biofeedback using mobile device plus autogenic training recording Receives: Behavioral: HRV Biofeedback; Behavioral: Autogenic Training |
| Wait List | No intervention | Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological sexual arousal assessed by vaginal photoplethysmography
Measured: One month
Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)
Measured: One month
Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)
Measured: Two months
Secondary outcomes (3)
Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)
Measured: Two months
Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)
Measured: Two months
Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual Arousal DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy M Meston, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958176
- Sponsor's protocol ID
- 2016-08-0074
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Imbalance and Female Sexual Arousal Disorder: The Identification of Heart Rate Variability Level as a Risk Factor and Treatment Target
- ClinicalTrials.gov ID
- NCT02958176
- Acronym / sponsor ID
- 2016-08-0074
- Conditions
- Female Sexual Arousal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HRV Biofeedback | Experimental | Behavioral: HRV BiofeedbackAt home HRV biofeedback using mobile device |
| HRV Biofeedback with Autogenic Training | Experimental | Behavioral: HRV Biofeedback, Behavioral: Autogenic TrainingAt home HRV biofeedback using mobile device plus autogenic training recording |
| Wait List | No intervention | –Wait list control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV BiofeedbackAt-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap | Behavioural | HRV Biofeedback, HRV Biofeedback with Autogenic Training |
| Autogenic TrainingAutogenic training recording provided on a CD | Behavioural | HRV Biofeedback with Autogenic Training |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy M Meston principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV Biofeedback and Autogenic Training in people with Female Sexual Arousal Disorder, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological sexual arousal assessed by vaginal photoplethysmography (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.