Clinical trial NCT05168371: Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction
Official title: Pilot RCT for Cognitive-Behavioural & Mindfulness-Based Online Programs for Female Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 129
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in sexual distress
timeFrame: 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: Change in sexual desire
timeFrame: 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:
measure: Change in sexual function
timeFrame: 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: Change in sexual satisfaction
timeFrame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
measure: Change in relational sexual concern
timeFrame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
measure: Change in relationship satisfaction
timeFrame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
measure: Treatment satisfaction for module 1
timeFrame: An average of 1 week after starting the 8-module program
measure: Treatment satisfaction for module 2
timeFrame: An average of 2 weeks after starting the 8-module program
measure: Treatment satisfaction for module 3
timeFrame: An average of 3 weeks after starting the 8-module program
measure: Treatment satisfaction for module 4
timeFrame: An average of 5 weeks after starting the 8-module program
measure: Treatment satisfaction for module 5
timeFrame: An average of 6 weeks after starting the 8-module program
measure: Treatment satisfaction for module 6
timeFrame: An average of 7 weeks after starting the 8-module program
measure: Treatment satisfaction for module 7
timeFrame: An average of 9 weeks after starting the 8-module program
measure: Treatment satisfaction for module 8
timeFrame: An average of 10 weeks after starting the 8-module program
measure: Quantitative program treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction
timeFrame: post-treatment (within 2 weeks of completing the 8-module program)
measure: Qualitative program treatment satisfaction
timeFrame: through completion of the 8-module program, an average of 10 weeks
measure: Change in satisfaction with life
timeFrame: baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Other outcomes:
measure: Change in depression (mediator)
timeFrame: 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: Change in sexual avoidance (mediator)
timeFrame: 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: Change in sexual consequences (mediator)
timeFrame: 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: Participants' baseline expectations about treatment efficacy assessed by two face-valid items (moderator)
timeFrame: baseline
measure: Treatment compliance: Single-item measure of between-module activity completion (moderator)
timeFrame: through completion of the 8-module program, an average of 10 weeks
measure: Treatment compliance: Between-module activity completion assessed by Homework Rating Scale-II (moderator)
timeFrame: through completion of the 8-module program, an average of 10 weeks
measure: Treatment compliance: Navigator adherence to study guidelines (moderator)
timeFrame: through completion of the 8-module program, an average of 10 weeks
measure: Treatment compliance: Number of weeks in program (moderator)
timeFrame: post-treatment (within 2 weeks of completing the 8-module program)
measure: Treatment compliance: Number of treatment sections of program completed (moderator)
timeFrame: post-treatment (within 2 weeks of completing the 8-module program)
measure: Treatment compliance: Participant engagement with website as assessed by Google Analytics data (moderator)
timeFrame: through completion of the 8-module program, an average of 10 weeks
measure: Perceived navigator empathy (moderator)
timeFrame: post-treatment (within 2 weeks of completing the 8-module program)
measure: Perceived navigator alliance (moderator)
timeFrame: post-treatment (within 2 weeks of completing the 8-module program)
measure: Partner Involvement (moderator)
timeFrame: post-treatment (within 2 weeks of completing the 8-module program)
measure: Big-Five personality traits (exploratory moderator)
timeFrame: baseline
measure: Change in PTSD symptoms (exploratory outcome)
timeFrame: 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
Locations:
city: Vancouver
country: Canada
facility: UBC Sexual Health Research Lab; Gordon & Leslie Diamond Health Care Centre
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Lori Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xavier University of Louisiana.
name: Kyle Stephenson, PhD
role: PRINCIPAL_INVESTIGATOR
References: