A Mindfulness-based Intervention for Older Women With Low Sexual Desire
Phase: NA
Conditions: Hypoactive Sexual Desire Disorder, Sexual Dysfunction, Female Sexual Dysfunction
Sponsor: University of Pittsburgh

Study protocol 
NCT03232801 
Title: A Mindfulness-Based Intervention for Older Women with Low Sexual Desire 
Version date: August 1, 2022 
 
Study Rationale 
Sex is a fundamental component of overall well-being for many adults. Individuals who maintain a healthy sex 
life with aging live longer and gave high quality of life. However, sexual function problems are common, 
particularly among midlife women; 39% of this population struggles with low sexual desire. This can affect not 
only a women’s sex life, but also negatively impact on psychosocial functioning and relationships. 
Despite success in developing treatment for men, there has been a lack of treatment options for women. An 
increasingly accepted model of female sexual response emphasizes both physiologic and psychologic aspects 
of female sexual function. Pharmacologic treatments that only target physiologic response will only help a 
subset of women. In contrast, behavioral interventions have the potential to target both physiologic and 
psychological aspects of female sexual function. Using this rationale, this study will look at the use of a 
mindfulness study to improve sexual function in midlife women. Female sexual dysfunction is associated with 
sexually-related anxiety, autonomic nervous system imbalance, negative body image, discursive negative 
thoughts that distract during sex, and poor sleep.  
Using this rationale, this study will look at the use of a mindfulness study to improve sexual function in midlife 
women. Mindfulness, a concept that emphasizes in-the-moment focus and non-judgmental bodily awareness, 
can target all these aspects of sexual dysfunction simultaneously by decreasing anxiety, improving autonomic 
imbalance, enhancing body image, reducing distracting thoughts, and improving sleep. 
Treating sexual dysfunction will result in improvements in women’s sexuality and can have the opportunity to 
go beyond sex to improve relationships and overall quality of life in aging adults. At least 85% of women in the 
intervention group will indicate somewhat or very satisfied on a measure of the intervention satisfaction. 
 
A multi-component, mindfulness-based intervention, developed by Dr. Lori Brotto at the University of British 
Columbia, has shown preliminary efficacy in smaller studies for the treatment of desire, arousal, and sexual pain 
disorders (1-6). However, these studies lacked control groups or used wait-list controls. Additionally, this 
intervention was developed and tested primarily among women in their 30s and 40s. Whether and how this 
intervention works in older women is not known. Older women have unique physical and psychological sexual 
health needs that are not adequately addressed by the existing intervention. Older women are more likely to 
have medical conditions, such as hypertension (7,8) or diabetes (9), or to be using medications, such as 
antidepressants (10) or antihypertensives (11), that can affect sexual function. Women over 50 may also have 
musculoskeletal pain and orthopedic issues that can negatively impact sexual function. Additionally, older 
women are more likely to experience problems with vaginal dryness and dyspareunia than younger women, as 
these changes are most prevalent for women in their 50s, 60s and beyond (13-15, 18). Further, the sexual 
outcomes that are most important to older women differ from those of younger women; while younger women 
prioritize physical outcomes, older women may consider emotional outcomes more important (16-18). Cohort 
effects may influence the acceptability of the intervention between younger and older women, such as openness 
to mindfulness-based approaches (19). Finally, older women may have different social roles – such as caregiver 
– that may affect their relationship with their partners, sexual function, and overall wellbeing (20)(21). The 
adapted intervention should ensure that we address these unique sexual health needs of older women. 
 
Known Risks and Benefits 
 
Benefits 
• 
Increased awareness of sexual genital sensations, attributed to increased awareness of present moment 
in their own bodies and decreased distraction  
• 
May allow women to tap in to their physical arousal to enhance overall sexual arousal, desire, and 
satisfaction 
• 
Decreasing anxiety, depression, and negative affect 
• 
Improved body image 
• 
Enhanced sleep quality 
Risks 
• 
Loss of confidentiality  

• 
Injury during light yoga sessions 
• 
 
To minimize risk, participant information is kept on a password protected computer behind a firewall. Additionally, 
through Zoom, participants can participate and give as much information as they feel comfortable with. 
Additionally, all participants have the opportunity to change their name on Zoom and allow them to decide 
whether they would like to keep their camera on or not.  
To reduce the risk of injury during yoga sessions, everyone is encouraged to only complete what they feel 
comfortable doing. Additionally, the yoga practice is kept as simple as possible and feasible for people of all 
ages and abilities.  
 
Recruitment 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and lifestyle considerations/availability for the 
duration of the study  
3. Females; Age 45 and older 
4. Self-reported diagnosis of low sexual desire/decrease in sexual desire 
5. Willingness to adhere to the 6-week program regimen 
 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Does not have a sexual partner who they would like to be sexually active with 
2. Requires assistance with bathing, dressing, toileting, and/or eating 
3. Experiencing symptoms of depression 
4. User of recreational drugs (excluding marijuana) 
5. Consumes more than 7 alcoholic beverages in one week 
6. Started a new medication for anxiety, depression, or other mental health problem in the past 3 months 
7. Currently in a relationship with a romantic partner that has pushed or slapped them, or threatened them 
with violence 
8. Very dissatisfied with their current romantic partner 
9. Experienced high or very high levels of pain during or following vaginal penetration 
 
Screen Failures 
Screen failures are defined as participants who consent to participate in this study but are not subsequently 
assigned to the study intervention or entered in the study. Individuals who do not meet the criteria for 
participation in this trial (screen failure) because of meeting one or more exclusion criteria are thanked for their 
time and given the opportunity to ask any questions. Examples of exclusions are those that have severe pain 
with vaginal penetration, more than 7 drinks in a week, or those who do not have a partner with whom they 
would like to be sexually active.  
 
Strategies for Recruitment and Retention 
Each group (control and experimental) will have roughly 12-15 people in order to keep the group size 
comfortable. If participant number is fewer than 12 people per group, the sessions can still be held. As long as 
participants are willing to join and participate, the sessions can still go on. We are limiting our recruitment only 
women who are 45 years and older. Due to the nature of this study, participants must be proficient in English.  
 
Women will be recruited via: (a) flyers placed at local internal medicine, gynecology, and sex therapy clinics; 
(b) advertisements in University of Pittsburgh and UPMC staff e-mail newsletters, in newspapers, and on 
buses; (c) presentations to UPMC providers that care for midlife women; (d) social media advertisements such 
as Facebook; (e) the CTSI Research Participant Registry; and (f) Pitt + Me. The advertisement used for 
Facebook will only be posted on the personal pages of study staff, and we will not encourage others to "Share" 
the posting. 
 

We will obtain verbal consent to perform telephone screening procedures, which involve minimal risk to the 
potential participant using the screening survey on RedCap. After telephone screening procedures, women 
who are eligible can be mailed or emailed detailed information on the study, if they are interested. 
 
For participants, the study will initially be described over the phone. Participants will have the opportunity to 
ask questions about the study at this time. The Research Assistant will review the consent form and any risks 
associated with the study. Participants will be given the opportunity to verbally consent at that time or to read 
over more information that will be sent by email or snail mail. This will take about 20 minutes. 
 
If uncomfortable with the study requirements, the participant may choose not to enroll in the study at this time. 
If the person decides to participate, they will be asked to complete a verbal consent over the phone. All 
documents specifically state that participation in the study is voluntary and the decision NOT to participate in 
the study will not have negative consequences for the participant. 
 
In order to increase retention and keep participants interested, women will receive $25 for completing each of 
the three assessments. An extra $25 will be given for completing all three assessments, for a total of $100 per 
participant. If interested, participants can complete an optional interview about the study at the completion of 
the sessions for a bonus of $20. 
 
 
STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
Women will be randomized into two separate groups. The active control group will attend six, two-hour 
sessions over six weeks in groups of approximately 12-15 women. The content of these sessions will focus on 
general health and aging (e.g., cardiovascular health, osteoporosis) and will include only limited information on 
sexual health. The use of an active control allows the study to control for group support and attention. It will 
also allow the study to explore women’s willingness to be randomized. 
Intervention will be given in the form of in person mindfulness training, including self-observation, meditation 
techniques, gentle yoga, and attention to breath. Additional content will include general sex education, sensate 
focus, and couples therapy, such as information on potential etiologies of sexual function and sexual response, 
bodily exploration exercises, and communication training. 
Both women in the control group and the experimental group will be lead by the PI and a trained expert in 
mindfulness-based stress reduction. Women in both groups have the opportunity to complete an optional 
phone interview with a RA at the completion of the sessions on their experience.  
 
Administration 
Following the screening, participants will be sent a survey link to complete all the baseline activities. Once the 
intervention starts, participants will attend a weekly virtual session with other members of their group (control 
vs variable). These sessions will last for six weeks at approximately two hours each. In these sessions, they 
have the possibility of interacting with members of their group and with the leaders of each group. However, 
group participation is up to the participant; they are able to share as little or as much as they feel comfortable.  
Following the completion of the sessions, a survey will be sent to participant. These surveys will be identical to 
the baseline surveys, excluding the surveys on Demographics, Relationship Variables, Frequency of Sexual 
Activities, and Medical Variables. There will also be an Acceptability of Intervention survey sent out at the finish 
of the sessions. Participants will have one week to fill out and return the surveys, which will be tracked through 
RedCap. 
At the 12 week mark, a final set of surveys will be sent out, identical to the baseline surveys, excluding the 
surveys on Demographics, Relationship Variables, Frequency of Sexual Activities, and Medical Variables. 
Participants will have one week to fill out and return the surveys, which will be tracked through RedCap. 
 
Interventionist Training and Tracking 
To ensure the completion of all surveys, in the week the survey is disseminated, progress will be monitored 
using RedCap. All surveys need to be returned within the week they are sent out so if progress is not being 
made by a participant, the RA will reach out up to three different times to send reminders and check in. The 
three contact points can be made via different methods, including through email and phone call. 
 
Discontinuation/Withdrawal 

An investigator may discontinue a participant from the study for the following reasons: 
 
• 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study 
objectives  
• 
Lost-to-follow up 
• 
Any event or medical condition or situation occurs such that continued collection of follow-up study data 
would not be in the best interest of the participant or might require an additional treatment that would 
confound the interpretation of the study 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation 
 
Participants are allowed to withdraw at any time for any reason. Data up until the point a participant 
discontinued the study will be included in the study. Participants will not to continue with surveys when 
participation is discontinued.  
If a participant misses more than 2 meetings, they are withdrawn from the study. They are still eligible for 
payment if they completed the first survey. If there are further six-week sessions, a participant can move to a 
later session that may fit their schedule.  
 
Loss to Follow-Up 
The following actions must be taken if a participant fails to return their surveys in the correct amount of time: 
 
• 
The site will attempt to contact the participant, remind them of the studies they have left to complete, 
counsel the participant on the importance of maintaining the assigned visit schedule, and ascertain if 
the participant wishes to and/or should continue in the study 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the participant. The investigator or designee will make up to 3 different attempts at 
contact with the participant. These attempts will include reaching out via phone or email. 
• 
Should the participant continue to be unreachable, they will be considered to have withdrawn from the 
study with a primary reason of lost to follow-up. 
 
Weekly Meetings 
Meetings for each group will be held on separate days. Following recruitment, a survey will be sent out to the 
participants to each group. Any survey system can be used to generate the surveys to gauge interest in the 
best day and time for the group (Qualtrics was used). Make sure that each group has a separate survey (i.e. 
an availability survey for both the mindfulness (experimental) and educational (control) group).  
Give the groups around one week to answer, sending out 1-2 reminders. Once a day and time is decided on, 
meetings can begin. An email can be sent to participants with the upcoming dates and the Zoom link. To 
ensure participants remember the meeting, an email should be sent every week, 12-24 hours before the 
meeting with the zoom link.  
Meetings are held every week for six weeks total. Meeting length is variable, but participants should prepare 
for a two-hour meeting.  
At each meeting, a research assistant should take attendance and keep track of who is coming to the 
meetings. This is important to record to ensure participants are making it to at least 4 meetings.   
 
Payment 
Payment will be made through The University of Pittsburgh’s Research Study payment system, Vincent. 
Information for payment includes Name, Address, and Birthdate. Participants are eligible to give their Social 
Security Number if they feel comfortable. If they would rather not include that information, 24% of their total will 
be taken. To help participants make the decision on whether to include their SSN or not, explain that it is 
needed for tax purposes. If a participant makes over $600 in studies per year, it becomes taxable income.  
Following the completion of the Zoom sessions, an email will be sent out with information on payment and for 
the opportunity to schedule a quick phone call to go over all the information. As with loss to follow-up, three 
contact attempts will be made to participants. If they do not answer following the three attempts, they are not 
paid.  
All Vincent cards are requested on the Vincent website. Each card in your inventory can be assigned to a 
participant. Some participants may have an existing account and card. If that is the case, have the participant 

verify their account by asking for their birthdate or address. If they match, make sure to ask whether they would 
prefer to keep their old card or if they would like a new card. 
After the completion of the twelve-week survey, cards are sent out or money is added the existing card (in the 
case of a participant having a pre-existing account).  
 
References 
 
1. 
Brotto LA, Seal BN, Rellini A. Pilot study of a brief cognitive behavioral versus mindfulness-based 
intervention for women with sexual distress and a history of childhood sexual abuse. Journal of sex & marital 
therapy. 2012;38(1):1-27. Epub 2012/01/25. doi: 10.1080/0092623X.2011.569636. PubMed PMID: 22268979. 
2. 
Brotto LA, Heiman JR, Goff B, Greer B, Lentz GM, Swisher E, et al. A psychoeducational intervention for 
sexual dysfunction in women with gynecologic cancer. Archives of sexual behavior. 2008;37(2):317-29. Epub 
2007/08/08. doi: 10.1007/s10508-007-9196-x. PubMed PMID: 17680353. 
3. 
Brotto LA, Erskine Y, Carey M, Ehlen T, Finlayson S, Heywood M, et al. A brief mindfulness-based 
cognitive behavioral intervention improves sexual functioning versus wait-list control in women treated for 
gynecologic 
cancer. 
Gynecologic 
oncology. 
2012;125(2):320-5. 
Epub 
2012/02/02. 
doi: 
10.1016/j.ygyno.2012.01.035. PubMed PMID: 22293042; PubMed Central PMCID: PMC3438201. 
4. 
Brotto LA, Basson, R., Carlson, M. & Zhu, C. Impact of an integrated mindfulness and cognitive 
behavioural treatment for provoked vestibulodynia (IMPROVED): A qualitative study. Sexual and Relationship 
Therapy. 2013;28(1-2):3-19. 
5. 
Brotto LA, Basson R, Luria M. A mindfulness-based group psychoeducational intervention targeting 
sexual arousal disorder in women. The journal of sexual medicine. 2008;5(7):1646-59. Epub 2008/05/30. doi: 
10.1111/j.1743-6109.2008.00850.x. PubMed PMID: 18507718. 
6. 
Brotto LA, Basson R, Smith KB, Driscoll M, Sandownik L. Mindfulness-based group therapy for women 
with provoked vestibulodynia. Mindfulness. 2014:1-16. 
7. 
Manolis A, Doumas M. Sexual dysfunction: the 'prima ballerina' of hypertension-related quality-of-life 
complications. 
Journal 
of 
hypertension. 
2008;26(11):2074-84. 
Epub 
2008/10/16. 
doi: 
10.1097/HJH.0b013e32830dd0c6. PubMed PMID: 18854743. 
8. 
Doumas M, Tsiodras S, Tsakiris A, Douma S, Chounta A, Papadopoulos A, et al. Female sexual 
dysfunction in essential hypertension: a common problem being uncovered. Journal of hypertension. 
2006;24(12):2387-92. Epub 2006/11/04. doi: 10.1097/01.hjh.0000251898.40002.5b. PubMed PMID: 17082720. 
9. 
Erol B, Tefekli A, Ozbey I, Salman F, Dincag N, Kadioglu A, et al. Sexual dysfunction in type II diabetic 
females: a comparative study. Journal of sex & marital therapy. 2002;28 Suppl 1:55-62. Epub 2002/03/20. doi: 
10.1080/00926230252851195. PubMed PMID: 11898710. 
10. 
Serretti A, Chiesa A. Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis. 
Journal 
of 
clinical 
psychopharmacology. 
2009;29(3):259-66. 
Epub 
2009/05/15. 
doi: 
10.1097/JCP.0b013e3181a5233f. PubMed PMID: 19440080. 
11. 
Thomas HN, Evans GW, Berlowitz DR, Chertow GM, Conroy MB, Foy CG, et al. Antihypertensive 
medications and sexual function in women: baseline data from the SBP intervention trial (SPRINT). Journal of 
hypertension. 2016;34(6):1224-31. Epub 2016/04/01. doi: 10.1097/HJH.0000000000000911. PubMed PMID: 
27032074; PubMed Central PMCID: PMC4859426. 
12. 
Castelo-Branco C, Cancelo MJ, Villero J, Nohales F, Julia MD. Management of post-menopausal vaginal 
atrophy 
and 
atrophic 
vaginitis. 
Maturitas. 
2005;52 
Suppl 
1:S46-52. 
Epub 
2005/09/06. 
doi: 
10.1016/j.maturitas.2005.06.014. PubMed PMID: 16139449. 
13. 
Dennerstein L, Dudley EC, Hopper JL, Guthrie JR, Burger HG. A prospective population-based study of 
menopausal symptoms. Obstetrics and gynecology. 2000;96(3):351-8. Epub 2000/08/29. PubMed PMID: 
10960625. 

14. 
Woods NF, Mitchell ES. Symptoms during the perimenopause: prevalence, severity, trajectory, and 
significance in women's lives. The American journal of medicine. 2005;118 Suppl 12B:14-24. Epub 2006/01/18. 
doi: 10.1016/j.amjmed.2005.09.031. PubMed PMID: 16414323. 
15. 
Avis NE, Brockwell S, Randolph JF, Jr., Shen S, Cain VS, Ory M, et al. Longitudinal changes in sexual 
functioning as women transition through menopause: results from the Study of Women's Health Across the 
Nation. Menopause. 2009;16(3):442-52. Epub 2009/02/13. doi: 10.1097/gme.0b013e3181948dd0. PubMed 
PMID: 19212271; PubMed Central PMCID: PMC2908487. 
16. 
Winterich JA. Sex, menopause, and culture: Sexual orientation and the meaning of menopause for 
women's sex lives. Gender & Society. 2003;17(4):627-4. doi: 10.1177/0891243203253962. 
17. 
Thomas HN, Hamm M, Hess R, Borrero S, Thurston RC. Patient-Centered Sexual Function Outcomes 
among Midlife Women. Journal of Women's Health. 2016;25(4):A1-A35. Epub 3-31-2016. doi: 
10.1089/jwh.2016.20996.abstracts. 
18. 
Ginsberg TB, Pomerantz SC, Kramer-Feeley V. Sexuality in older adults: behaviours and preferences. 
Age and ageing. 2005;34(5):475-80. Epub 2005/07/27. doi: 10.1093/ageing/afi143. PubMed PMID: 16043445. 
19. 
Morone NE, Greco CM, Weiner DK. Mindfulness meditation for the treatment of chronic low back pain in 
older adults: a randomized controlled pilot study. Pain. 2008;134(3):310-9. Epub 2007/06/05. doi: 
10.1016/j.pain.2007.04.038. PubMed PMID: 17544212; PubMed Central PMCID: PMC2254507. 
20. 
Martire LM, Stephens MA, Townsend AL. Centrality of women's multiple roles: beneficial and detrimental 
consequences for psychological well-being. Psychology and aging. 2000;15(1):148-56. Epub 2001/02/07. 
PubMed PMID: 10755296. 
21. 
Martire LM, Stephens MA, Atienza AA. The interplay of work and caregiving: relationships between role 
satisfaction, role involvement, and caregivers' well-being. The journals of gerontology Series B, Psychological 
sciences and social sciences. 1997;52(5):S279-89. Epub 1997/10/06. PubMed PMID: 9310100.