NCT05168371

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

HYPOTHESES: 1. 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. 2. 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. 3. Improvements in depression, sexual avoidance, and sexual consequences will significantly mediate improvements in primary outcomes at all post-treatment assessment points. 4. 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. 5. Baseline personality will moderate intervention effects at post-treatment and follow-up. 6. Women in both the CBT and MBT arms will report being satisfied with treatment.

Conditions

• Female Sexual Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-Behavioural Therapy - Online (CBT-O)	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.
BEHAVIORAL	Mindfulness-Based Therapy - Online (MBT-O)	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.

Timeline

• Start date: 2021-11-12
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2021-12-23
• Last updated: 2025-03-26

Locations

1 site across 1 country: Canada