Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction

Study Overview
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Brief Summary
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Female sexual dysfunction (FSD) affects approximately one-third of women worldwide and is linked to negative physical, psychological, and interpersonal outcomes. Although both cognitive-behavioral therapy and mindfulness-based therapy are effective treatments for FSD, face-to-face treatments can be costly and are inaccessible to many people in remote areas. The goal of the current study is to pilot a randomized controlled trial to examine the effectiveness of and satisfaction with two online interventions for FSD. Women will be randomized to an online cognitive-behavioral program, an online mindfulness-based program, or a wait-list control group. Treatment will be administered entirely online and last 8-12 weeks. Women will meet weekly via Zoom with a navigator who will provide individualized support.

Detailed Description
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HYPOTHESES: Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the primary outcomes: (a) sexual distress and (b) sexual desire. Compared to women in the wait-list control arm, women in the CBT and MBT arms will have significant post-treatment and follow-up improvements in self-report measures of the secondary outcomes: (a) overall sexual function, (b) sexual satisfaction, (c) relational sexual concern, (d) satisfaction with life, and (e) relationship satisfaction. Improvements in depression, sexual avoidance, and sexual consequences will significantly mediate improvements in primary outcomes at all post-treatment assessment points. Higher levels of baseline relationship satisfaction, higher levels of partner involvement, more positive baseline expectations about treatment efficacy, higher levels of treatment compliance, and perceiving higher levels of empathy and effectiveness from navigators will predict greater improvements in primary outcomes at post-treatment and follow-up. Baseline personality will moderate intervention effects at post-treatment and follow-up. Women in both the CBT and MBT arms will report being satisfied with treatment.

Official Title
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Pilot RCT for Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction

Conditions
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Female Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Cognitive-Behavioural Therapy - Online (CBT-O)
* Behavioral: Mindfulness-Based Therapy - Online (MBT-O)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cis and trans women of any sexual orientation. Must be fluent in English (online materials delivered in English). Must have consistent access to the internet, basic competency in using online platforms (self-report). Must be in a committed, stable romantic relationship of at least 6 months (because aspects of the interventions require partner participation). Partners may be of any gender. Must meet telephone screening diagnostic criteria for sexual interest/arousal disorder. Must be sexually active with a partner over the preceding 4 weeks (due to the sexual function outcome measure), and willing to engage in sexual activity with their partner during the study. Must be able to participate in an 8-12-week online treatment. Exclusion Criteria: Have sexual dysfunction that is, in their estimation, fully attributable to another psychiatric diagnosis, the effect of a substance, a general medical condition (e.g., Multiple Sclerosis), or non-sexual conflict in the relationship, none of which are meant to be addressed by the proposed interventions. Poorly managed Anxiety or Mood Disorder (as per degree of life interference assessed at screening). Report visual impairments that would make it difficult to read online materials. Are regularly using prescription narcotics illegal recreational drug (not including cannabis). Plan to change their medications known to impact sexual function over the course of the study. On assessment report plans to end their romantic relationship in the next 6 months. Engage in any other treatment for their sexual difficulties during the study.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-O<br>Women randomized to this arm will receive access to the eight modules of Cognitive-Behavioural Therapy-Online (CBT-O). Participants will meet weekly via Zoom with treatment navigators during the 8-12 weeks that it takes to complete the program. | Behavioral: Cognitive-Behavioural Therapy - Online (CBT-O)<br>* Face-to-face CBT was adapted for web-based self-directed therapy. CBT-O was found to be feasible and usable (Stephenson et al., 2021; Zippan et al., 2020). Each of the eight modules has between-module activities to complete. The eight modules are: 1) Psychoeducation, introduction to CBT; 2) The cognitive model and thought records; 3) Unhelpful thinking patterns; 4) Cognitive restructuring; 5) Behavioral experiments; 6) Self-touch and sensate focus; 7) Sensate focus with your partner; and 8) Maintaining (and extending) your gains.<br>|
| Experimental: MBT-O<br>Women randomized to this arm will receive access to the eight modules of Mindfulness-Based Therapy-Online (MBT-O). Participants will meet weekly via Zoom with treatment navigators during the 8-12 weeks that it takes to complete the program. | Behavioral: Mindfulness-Based Therapy - Online (MBT-O)<br>* The content of MBT-O was adapted from an efficacious face-to-face mindfulness intervention for women with Sexual Interest/Arousal Disorder (Brotto et al., 2021; Paterson et al., 2017). MBT-O was found to be feasible and usable (Brotto et al., under review). Each of the eight modules has between-module activities to complete. The eight modules are: 1) Psychoeducation, introduction to mindfulness; 2) Increasing awareness of physical sensations in the body; 3) Exploring movement and body image; 4) Awareness of sexual thoughts and beliefs; 5) Working with aversion, self-touch; 6) Exploring sexual sensations, knowing limits; 7) Integrating the partner into mindful touching; and 8) Maintaining (and extending) your gains.<br>|
| No Intervention: Wait-List Control<br>Participants who are randomized to the wait-list group will complete two baseline online questionnaire/assessment batteries before being randomized to one of the active treatment groups. Participants will be randomized into one of the active treatment groups after a 10 week waiting period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual distress | Revised version of the Female Sexual Distress Scale-R (Derogatis et al., 2008). Scores on the scale range from 0-52, where higher scores represent higher levels of distress. | baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up | 
| Change in sexual desire | The Sexual Interest and Desire Inventory (SIDI; Clayton et al. 2006) total score will be used to measure sexual desire. Possible total scores range from 0-51, with higher scores indicating higher levels of sexual functioning. | baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual function | Female Sexual Function Index total score (FSFI; Rosen et al., 2000). Scores range from 2 - 36 where increase in sexual dysfunction is represented by lower scores. | baseline; mid-treatment (an average of 5 weeks after starting the 8-module program); post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up | 
| Change in sexual satisfaction | Quality of Sex Inventory (QSI; Shaw & Rogge, 2016). For all items, responses are given values on a 0 to 5 point scale with 0 = Not at all TRUE and 5 = Completely TRUE. The items of the sexual satisfaction subscale are summed to create a total where higher scores indicate higher levels of sexual satisfaction (0-60). The items of the sexual dissatisfaction subscale are summed separately to create a total where higher scores reflect higher levels of sexual dissatisfaction (0-60). | baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up | 
| Change in relational sexual concern | Relational concern subscale of the Sexual Satisfaction Scale-Women (SSS-W; Meston & Trapnell, 2005). Scores range from 6-30, with higher scores reflecting lower levels of sexual relational concern. | baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up | 
| Change in relationship satisfaction | Couples satisfaction index (CSI-16; Funk & Rogge, 2007). CSI-16 scores can range from 0 to 81. Higher scores indicate higher levels of relationship satisfaction. | baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up | 
| Treatment satisfaction for module 1 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 1. | An average of 1 week after starting the 8-module program | 
| Treatment satisfaction for module 2 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 2. | An average of 2 weeks after starting the 8-module program | 
| Treatment satisfaction for module 3 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 3. | An average of 3 weeks after starting the 8-module program | 
| Treatment satisfaction for module 4 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 4. | An average of 5 weeks after starting the 8-module program | 
| Treatment satisfaction for module 5 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 5. | An average of 6 weeks after starting the 8-module program | 
| Treatment satisfaction for module 6 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 6. | An average of 7 weeks after starting the 8-module program | 
| Treatment satisfaction for module 7 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 7. | An average of 9 weeks after starting the 8-module program | 
| Treatment satisfaction for module 8 | Face-valid single item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing module 8. | An average of 10 weeks after starting the 8-module program | 
| Quantitative program treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction | Adapted Erectile Dysfunction Inventory of Treatment Satisfaction (Althof et al., 1999; items 1-10). Scores range from 0-40, with higher scores reflecting higher treatment satisfaction. | post-treatment (within 2 weeks of completing the 8-module program) | 
| Qualitative program treatment satisfaction | Qualitative feedback about eSense and between-module activities collected by treatment navigators. | through completion of the 8-module program, an average of 10 weeks | 
| Change in satisfaction with life | Satisfaction with Life Scale (Diener et al., 1985). Scores range from 5-35, with higher scores reflecting higher levels of life satisfaction. | baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Desire, Mindfulness, Cognitive Behavioral Therapy, Cognitive Behavioural Therapy, Mindfulness Based Therapy, Digital Health, Sexual Interest/Arousal Disorder, Female Sexual Dysfunction