UBC Sexual Health Research Lab; Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
NCT Number: NCT05168371
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Vancouver, British Columbia, V5Z 1M9, Canada
HYPOTHESES:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
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).
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
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.
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
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.
Time frame: An average of 1 week after starting the 8-module program
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.
Time frame: An average of 2 weeks after starting the 8-module program
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.
Time frame: An average of 3 weeks after starting the 8-module program
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.
Time frame: An average of 5 weeks after starting the 8-module program
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.
Time frame: An average of 6 weeks after starting the 8-module program
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.
Time frame: An average of 7 weeks after starting the 8-module program
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.
Time frame: An average of 9 weeks after starting the 8-module program
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.
Time frame: An average of 10 weeks after starting the 8-module program
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.
Time frame: post-treatment (within 2 weeks of completing the 8-module program)
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.
Time frame: through completion of the 8-module program, an average of 10 weeks
Qualitative feedback about eSense and between-module activities collected by treatment navigators.
Time frame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Satisfaction with Life Scale (Diener et al., 1985). Scores range from 5-35, with higher scores reflecting higher levels of life satisfaction.
Time frame: 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
Patient Health Questionnaire (PHQ-9). Scores can range from 0-27, with higher scores indicating more depression symptoms.
Time frame: 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
The Golombok Rust Inventory of Sexual Satisfaction (GRISS) Questionnaire (female) - Sexual Avoidance Subscale. Scores can range from 0-16, with higher scores indicating higher levels of sexual avoidance.
Time frame: 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
Measure of Sexual Consequences (Stephenson et al., 2018). Scores can range from 11-55, with higher scores indicating more frequent negative sexual consequences.
Time frame: baseline
measured using two items: "To what extent to you think the treatment you will receive is logical in terms of alleviating your sexual desire concerns?" and "To what extent do you expect improvement in your sexual desire as a result of this treatment?"
Time frame: through completion of the 8-module program, an average of 10 weeks
navigators will ask participants to rate between-module activity completion on a 1-7 Likert scale ranging from "did not attempt" to "successfully completed all assignments" weekly
Time frame: through completion of the 8-module program, an average of 10 weeks
participants complete the Homework Rating Scale-II (HRS-II) after each module. Scores can range from 0-48, with higher scores reflecting high levels of between-module activity completion.
Time frame: through completion of the 8-module program, an average of 10 weeks
measuring navigator adherence to study guidelines by recording a random 50% of Zoom sessions (participants will be informed of these recordings) and coding navigator sessions for adherence using an adherence measure developed by investigators that access adherence to study guidelines, with higher scores reflecting higher levels of adherence to study guidelines.
Time frame: post-treatment (within 2 weeks of completing the 8-module program)
Recording number of weeks participant took to complete the program.
Time frame: post-treatment (within 2 weeks of completing the 8-module program)
Recording number of treatment sections participants complete.
Time frame: through completion of the 8-module program, an average of 10 weeks
eSense website engagement assessed by Google analytics data (e.g., total duration of time on website). This will provide a measure of participant engagement.
Time frame: post-treatment (within 2 weeks of completing the 8-module program)
Empathy subscale of the Barrett-Lennard Relationship Inventory (Barrett-Lennard, 2015). Scores range from -48 to 48, with higher scores reflecting that participants perceive higher levels of empathy in their navigator.
Time frame: post-treatment (within 2 weeks of completing the 8-module program)
Perceived navigator alliance with the Working Alliance Inventory, Short Form (Hatcher & Gillaspy, 2006). Scores range from 12-84, with higher levels reflecting that participants perceive higher levels of working alliance with their navigator.
Time frame: post-treatment (within 2 weeks of completing the 8-module program)
Two face-valid questions asking how much their partners were involved with and supportive of their treatment. The items are: "How involved has your partner been with your participation over the course of your involvement with eSense (e.g., talking to you about your participation, viewing modules themselves, participating in activities)?" and "How supportive has your partner been of your participation in the eSense program?"
Time frame: baseline
Big Five Inventory-10 (BFI-10; Rammstedt & John, 2007)
Time frame: 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
PTSD Checklist (PCL) - 5; 4-item version (Price et al., 2016). Scores can range from 0-16, with higher scores indicating more severe PTSD symptomatology.
University of British Columbia
Other
Pilot RCT for Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction
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