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Mindfulness is a promising intervention for female sexual dysfunction FSD ; however, of the mindfulness interventions studied, few treat the woman and her partner. We developed a brief online mindfulness, resilience, and psychoeducation intervention, Stress Management and Resiliency Training for Sexuality Sex SMARTfor women with sexual health concerns and their partners. The study included 60 women and their partners 30 couples in each group. Both participants and partners randomized to the intervention reported ificantly improved attitude and feelings, comfort as a sexual person, and subjective sexual functioning at 12 weeks.

The findings provide preliminary evidence for efficacy of an online intervention for couples with sexual health problems. Although this is the first online randomized controlled trial to evaluate a mindfulness-based therapy intervention, it was limited by its lack of population diversity and high attrition rate. ificant improvements in subjective sexual health and partner sexual function by the International Index of Erectile Function were reported only in the intervention group. Sex Med ; Mindfulness is commonly defined as intentional, present moment, nonjudgmental awareness.

They may monitor their sexual performance as a success or failure, known as spectatoring. Resilience is a multifaceted construct that comprises several personal resources, such as self-esteem, optimism, flexibility, coping strategies, and good social relations. It involves the relational capacity to adapt, grow, and recover from challenges.

However, there is minimal existing literature on mindfulness- and resilience-based interventions for female sexual dysfunction FSD. The consistent components of this therapy include mindfulness, sexual psychoeducation, and elements of cognitive therapy. In 3 wait-list controlled trials, Brotto and Basson 10 and Brotto et al 1112 showed that a mindfulness program ificantly improved women's sexual desire, arousal, satisfaction, vaginal lubrication, genital pain, and overall sexual functioning as indicated by a validated measure of sexual function.

Their findings related to improved sexual desire and sexual pain were subsequently supported by 2 randomized controlled trials RCTs on MBT for sexual dysfunction. Further, a comparison study of mindfulness-based cognitive therapy MBCT versus CBT for the treatment of provoked vulvodynia found that, for a subsample of sexually active women, MBCT was more effective than CBT in reducing self-reported sexual pain over time.

The concept of MBT has now been extended to online interventions. Brotto and colleagues 18 incorporated MBT into a week online psychoeducational intervention for sexual dysfunction in gynecologic cancer survivors and in male and female colorectal cancer survivors.

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Findings indicated ificant improvement for women with sexually related distress and sexual dysfunction at the completion of the program and at 6-month follow-up. Men reported a ificant improvement in intercourse satisfaction, which was not maintained at 6-month follow-up. Hucker and McCabe 19 incorporated mindfulness in a 6-module online CBT program for women with self-reported sexual difficulties desire, arousal, orgasm, and pain. Women reported ificant improvements in all domains of sexual function except pain, and benefits were maintained at 3-month follow-up. Male partners reported ificant improvements in erectile function EFsexual desire, and overall sexual satisfaction, which were mostly maintained at 3-month follow-up.

The expansion of mindfulness-based interventions to an online format is an important step toward removing geographical and emotional barriers to in-person treatments. In addition, MBT is particularly well suited as a couple's intervention. Mindfulness has repeatedly been shown to improve relationship satisfaction.

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Existing studies on MBT for sexual health concerns have some important limitations. Only one study to date 19 has included the woman's partner, yet the existing literature supports that couple's sexual health interventions are superior to individual interventions for FSD. The current study addresses these limitations. The study was deed as an online randomized controlled MBT, resilience enhancement, and psychoeducation intervention for women with sexual health concerns and their partners. The primary aim of the study was to assess the feasibility and potential efficacy of using Stress Management and Resiliency Training for Sexuality Sex SMART to improve sexual function in women who reported sexual health concerns and distress associated with these concerns and to include their partners in the treatment.

With this aim in mind, a randomized phase II trial was deed to assess the potential feasibility of delivering an online intervention to women with sexual health concerns and their partners and to test its efficacy, with the additional goal of providing preliminary data for a larger phase III trial in the future.

We hypothesized that it would be feasible to offer an online mindfulness, resilience, and psychoeducation program to couples with sexual health concerns. The present study was a randomized, wait-list controlled clinical trial. The institutional review board at our institution approved this study. Therefore, we sought to recruit a total of 60 couples, 30 per group. Potential participant couples were recruited from loco-regional and distant sites between February 24,and October 6,via print, radio, and newspaper advertisements.

This was a couple's study, and eligible participants had to be in a partnered relationship where the female participant reported sexual dysfunction. Hence, the study identified women with sexual dysfunction as participants and their respective male or female sexual companions as partners. Eligibility criteria were verified via a phone screening conducted by the study coordinator. They needed to endorse at least 3 symptoms for a minimum of 6 months and report ificant distress related to these symptoms, in order to be eligible for this study. Both participant and partner had to be over 18 years of age and willing to participate in an online intervention, have reliable internet access, and speak fluent English.

Couples were excluded if a participant reported dyspareunia not relieved by use of a personal lubricant, was taking flibanserin within the 3 months before enrolling, had an unstable psychiatric disorder in the 3 months before enrolling, or was taking a psychotropic or antidepressant medication and was not on a stable dose. Interested individuals called a central and underwent a minute telephone prescreen interview with the study coordinator S. Those who passed the prescreen interview were invited to attend a face-to-face consent visit.

During the consent visit, details of the study were discussed, and a written informed consent document was ed.

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The couples were told the difference between the 2 groups ie, the intervention group would receive the educational information and active intervention immediately, whereas the control group would receive educational information to review for 3 months before receiving the active intervention. Study flow diagram. From module 1, the participant and her partner learned stress management and resiliency training through 12 brief online videos approximately minutes in total and read corresponding book chapters before each online module from The Mayo Clinic Guide to Stress-Free Living a Stress Management and Resiliency Training [SMART] self-help book.

Finally, each session ended with a posttest. The daily practice in this program was not ritualized and required minimal time commitment because the practices were deed to be integrated into the individual's life. After the couples completed module 1 ideally within 2 weeksthey were instructed to practice incorporating the SMART practices into their daily routines for the next 2 weeks. Couples were then ed the link for module 2, the sexual health education module.

Module 2 provided couples with information for enhancing their sexual and overall relationship by utilizing SMART skills specifically for sexual health. Couples were to complete 7 sessions 30 minutes each consisting of brief videos and worksheet exercises ideally within 2 weeks.

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Couples randomized to the control group were sent 2 pamphlets and a link to a video on intimacy, which were attached to the introductory study. The pamphlet topics included information on stress management and sexual health to assist with improving their sexual relationships, which the couple was instructed to discuss.

After 3 months, the couples in the control group received online links for the Sex SMART intervention, as described above. Outcome measures were assessed for both study groups via online questionnaires at baseline and at 3 months, 6 months, and 12 months after completion of the intervention.

In addition, the control group was assessed 3 months after receiving the pamphlets and before beginning the active intervention. The FSFI is a validated questionnaire that measures self-reported sexual function over the past 4 weeks with a total score in addition to the following domains: sexual desire, vaginal lubrication, sexual arousal, orgasm, sexual pain, and sexual satisfaction. Scores for each domain range from 0 to 6, and total sexual function scores range from 2 to 36, with higher scores indicating better sexual function.

The secondary end points were self-reported change in sexual function, comfort with sexuality, satisfaction with sexual function, and satisfaction with partner participation, as assessed with subjective questions developed by the authors Figure 2. Questions included: 1 Have your attitudes or feelings improved since your participation in this program?

Subjective assessment of women and their partners. For each of the questionsthe possible response options were none, slight, moderate, very much, and extreme. The first bar for each question represents the percentage of participants reporting improvement, and the second bar represents the percentage of controls reporting improvement.

Arrows indicate questions with responses showing ificant differences between groups. Sexual desire was measured by the Sexual Desire Inventory-2 SDI-244 a item questionnaire that assesses self-reported levels of sexual desire and desired versus actual frequency of both solo and dyadic sexual behavior. Response items are based on 5- to 6-point Likert scales, with total scores ranging from 0 to Higher scores indicate greater relationship satisfaction, with a total score of less than 48 indicating relationship distress.

Only female participants received this questionnaire. Higher scores indicate more sexual distress. A score of 11 or greater indicates FSD. Only male participants received this questionnaire. Responses are Likert scales, with scores ranging from 5 to There are 5 subscales: EF scores range fromorgasmic function, sexual desire, intercourse satisfaction, and overall sexual satisfaction.

Higher scores indicate better sexual function. Scores less than 14 on the EF domain suggest that a sexual health intervention is warranted. The IIEF has been shown to have both high internal consistency 0. Scores of 5, 10, and 15 correspond with mild, moderate, and severe anxiety, respectively. A score of 10 or greater indicates the likely presence of GAD. Items are rated from 0 to 4, with the total score ranging from 0 to The psychometric properties of the PSS-4 have been tested and found to be acceptable.

The SHS has been found to have good convergent validity 0. Partner engagement was measured with the following question: Is your partner still engaging in this study with you? Study visits were divided into 3 phases: screening, intervention, and follow-up. Couples were in the study for either 12 months intervention group or 15 months control group.

The screening phase included the participants completing a prescreening phone interview and an in-person consent with a screening visit. After completing the screening procedures, participants were given a sealed envelope containing a letter explaining the study, a mail-in version of the consent document, and a contact form for their partners.

Once a partner agreed to participate, the partner ed the consent document and returned it by mail with contact information. Using this information, the partner received a link to complete the screening procedure and the online demographic survey. Once the participant and her partner completed the consent and screening procedures, the couple was ased a couple-identifier and randomized by the study coordinator S.

After this envelope was opened, the study coordinator S. All other co-investigators remained blinded to the treatment randomization. They were also instructed to participate in study procedures together, complete their own online surveys when received, and complete compliance phone visits throughout the study according to study de. If randomized to the intervention group, couples received links to the online SMART module 1 with a username and password. These couples continued the active intervention for approximately 6 weeks.

Couples randomized to the control group were ed the video link and the 2 usual care pamphlets pertaining to stress management and sexual health to begin the first 3 months of their participation in the study. Approximately 3 months into the study, or for the intervention group, once the couple completed the active intervention, the participant and her partner were each sent links to the online 3-month questionnaire set to complete.

They also completed a subjective questionnaire Figure 2 adapted from a qualitative study by Brotto et al 43 to assess the intervention impact and barriers to treatment. Once the couple completed the 3-month survey, they began the next part of study participation. The intervention group began the follow-up phase of the study, and the control group was sent the link to begin the crossover participation with the study intervention. Once the control group completed the active intervention approximately 6 months after beginning the studythey began the follow-up phase.

The follow-up phase included compliance phone calls, reminder calls as needed, and surveys. For the intervention group, this phase began once the couples had completed participation in the active intervention and the 3-month questionnaires, and it ended 12 months from the start of the study.

For the control group, the follow-up phase began once the couple completed the crossover intervention and ended 15 months from the start of the study. To keep participants engaged in study participation, co-intervention phone calls and a reminder protocol were incorporated into the study schedule.

Co-intervention phone calls with the participant were completed 2 to 4 weeks after completion of the intervention and addressed compliance and answered participant questions. Phone calls to participants also occurred approximately 2 weeks before each survey set would be sent, to prompt questionnaire completion. The reminder protocol was developed to be used as necessary to determine a participant's intent and interest in continued participation. If certain milestones ie, consent, online questionnaires, online modules were not completed, the participants received 2 weekly reminders and then a phone call after 3 weeks.

If the participant did not respond or requested to stop participation, the couple was withdrawn from the study. If at any time the participant requested an extension, it was at the investigator's discretion to keep the couple in the study. The phone contacts were to encourage continued study progression, to determine desire to continue with study participation, and to ascertain participant and partner engagement.

In all cases, intention-to-treat analyses were performed, with all participants included in the analysis according to the group to which they were randomized. Because of the high percentage of missing data for the 6- and month assessments, these time points were not included in any analyses. For the primary analysis, the baseline value was carried forward for participants and partners who had missing information at 12 weeks.

A supplemental analysis of the primary and secondary end points was also performed without using the carry-forward approach for those with missing data complete case analysis. For each outcome, the within-treatment group change from baseline to week 12 was assessed using the paired t test.

Because the primary outcome FSFI was only relevant for the female participants, separate analyses were performed for these participants and their partners. For these analyses, the change from baseline to week 12 was compared between groups using analysis of covariance ANCOVAwith the baseline value included as a covariate.

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