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

NCT05168371 | Completed

• 1 other identifier: H20-03914
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female Sexual Dysfunction

Keywords

Sexual Desire; Mindfulness; Cognitive Behavioral Therapy; Cognitive Behavioural Therapy; Mindfulness Based Therapy; Digital Health; Sexual Interest/Arousal Disorder; Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Change in sexual function

  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

  baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up

• Change in relational sexual concern

  baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up

• Change in relationship satisfaction

  baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up

• Treatment satisfaction for module 1

  An average of 1 week after starting the 8-module program

Other Outcomes (15)

• Change in depression (mediator)

  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 avoidance (mediator)

  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 consequences (mediator)

  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

Study Arms (3)

CBT-O

EXPERIMENTAL

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)

MBT-O

EXPERIMENTAL

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)

Wait-List Control

NO INTERVENTION

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.

Interventions

Cognitive-Behavioural Therapy - Online (CBT-O) BEHAVIORAL

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.

CBT-O

Mindfulness-Based Therapy - Online (MBT-O) BEHAVIORAL

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.

MBT-O

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Sexual Health Research Lab; Gordon & Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

• Brotto LA, Stephenson KR, Marshall N, Balvan M, Okara Y, Mahar EA. Evaluating a Digital Health Tool Designed to Improve Low Sexual Desire in Women: Mixed-Methods Implementation Science Study. J Med Internet Res. 2025 Mar 25;27:e69828. doi: 10.2196/69828.

  PMID: 40132194 DERIVED

Study Officials

• Lori Brotto, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

• Kyle Stephenson, PhD

  Xavier University of Louisiana.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 23, 2021
• Study Start: November 12, 2021
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

CA (1)