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

NCT ID: NCT05168371

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-12
• Study Completion Date: 2023-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-O

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.

Group Type: EXPERIMENTAL

Cognitive-Behavioural Therapy - Online (CBT-O)

Intervention Type: 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.

MBT-O

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Therapy - Online (MBT-O)

Intervention Type: 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.

Wait-List Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Lori Brotto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori Brotto, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Kyle Stephenson, PhD

Role: PRINCIPAL_INVESTIGATOR

Xavier University of Louisiana.

Locations

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

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40132194 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H20-03914

Identifier Type: -

Identifier Source: org_study_id