Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder
Primary Purpose
Female Sexual Arousal Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HRV Biofeedback
Autogenic Training
Sponsored by
About this trial
This is an interventional treatment trial for Female Sexual Arousal Disorder
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
Sites / Locations
- The University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
HRV Biofeedback
HRV Biofeedback with Autogenic Training
Wait List
Arm Description
At home HRV biofeedback using mobile device
At home HRV biofeedback using mobile device plus autogenic training recording
Wait list control
Outcomes
Primary Outcome Measures
Physiological sexual arousal assessed by vaginal photoplethysmography
Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)
Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)
Secondary Outcome Measures
Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)
Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)
Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)
Full Information
NCT ID
NCT02958176
First Posted
October 31, 2016
Last Updated
October 10, 2018
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT02958176
Brief Title
Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder
Official Title
Autonomic Imbalance and Female Sexual Arousal Disorder: The Identification of Heart Rate Variability Level as a Risk Factor and Treatment Target
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Arousal Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HRV Biofeedback
Arm Type
Experimental
Arm Description
At home HRV biofeedback using mobile device
Arm Title
HRV Biofeedback with Autogenic Training
Arm Type
Experimental
Arm Description
At home HRV biofeedback using mobile device plus autogenic training recording
Arm Title
Wait List
Arm Type
No Intervention
Arm Description
Wait list control
Intervention Type
Behavioral
Intervention Name(s)
HRV Biofeedback
Intervention Description
At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
Intervention Type
Behavioral
Intervention Name(s)
Autogenic Training
Intervention Description
Autogenic training recording provided on a CD
Primary Outcome Measure Information:
Title
Physiological sexual arousal assessed by vaginal photoplethysmography
Time Frame
One month
Title
Subjective sexual arousal assessed by Film Scale (Heiman & Rowland, 1983)
Time Frame
One month
Title
Sexual function assessed by Female Sexual Function Index (Rosen et al., 2000)
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Depression symptoms assessed by Beck Depression Inventory-II (Beck, Brown, & Steer, 1996)
Time Frame
Two months
Title
Anxiety symptoms assessed by Beck Anxiety Inventory (Beck et al., 1988)
Time Frame
Two months
Title
Interoceptive awareness assessed by the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012)
Time Frame
Two months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy M Meston
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Heart Rate Variability Biofeedback for Female Sexual Arousal Disorder
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