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

Female Sexual Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05168371
• Other study ID #: H20-03914
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Female Sexual Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	UBC Sexual Health Research Lab; Gordon & Leslie Diamond Health Care Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in depression (mediator)	Patient Health Questionnaire (PHQ-9). Scores can range from 0-27, with higher scores indicating more depression symptoms.	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
Other	Change in sexual avoidance (mediator)	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.	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
Other	Change in sexual consequences (mediator)	Measure of Sexual Consequences (Stephenson et al., 2018). Scores can range from 11-55, with higher scores indicating more frequent negative sexual consequences.	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
Other	Participants' baseline expectations about treatment efficacy assessed by two face-valid items (moderator)	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?"	baseline
Other	Treatment compliance: Single-item measure of between-module activity completion (moderator)	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	through completion of the 8-module program, an average of 10 weeks
Other	Treatment compliance: Between-module activity completion assessed by Homework Rating Scale-II (moderator)	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.	through completion of the 8-module program, an average of 10 weeks
Other	Treatment compliance: Navigator adherence to study guidelines (moderator)	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.	through completion of the 8-module program, an average of 10 weeks
Other	Treatment compliance: Number of weeks in program (moderator)	Recording number of weeks participant took to complete the program.	post-treatment (within 2 weeks of completing the 8-module program)
Other	Treatment compliance: Number of treatment sections of program completed (moderator)	Recording number of treatment sections participants complete.	post-treatment (within 2 weeks of completing the 8-module program)
Other	Treatment compliance: Participant engagement with website as assessed by Google Analytics data (moderator)	eSense website engagement assessed by Google analytics data (e.g., total duration of time on website). This will provide a measure of participant engagement.	through completion of the 8-module program, an average of 10 weeks
Other	Perceived navigator empathy (moderator)	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.	post-treatment (within 2 weeks of completing the 8-module program)
Other	Perceived navigator alliance (moderator)	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.	post-treatment (within 2 weeks of completing the 8-module program)
Other	Partner Involvement (moderator)	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?"	post-treatment (within 2 weeks of completing the 8-module program)
Other	Big-Five personality traits (exploratory moderator)	Big Five Inventory-10 (BFI-10; Rammstedt & John, 2007)	baseline
Other	Change in PTSD symptoms (exploratory outcome)	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.	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
Primary	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
Primary	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	Change in sexual function	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.	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	Change in sexual satisfaction	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).	baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Secondary	Change in relational sexual concern	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.	baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Secondary	Change in relationship satisfaction	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.	baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up
Secondary	Treatment satisfaction for module 1	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.	An average of 1 week after starting the 8-module program
Secondary	Treatment satisfaction for module 2	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.	An average of 2 weeks after starting the 8-module program
Secondary	Treatment satisfaction for module 3	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.	An average of 3 weeks after starting the 8-module program
Secondary	Treatment satisfaction for module 4	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.	An average of 5 weeks after starting the 8-module program
Secondary	Treatment satisfaction for module 5	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.	An average of 6 weeks after starting the 8-module program
Secondary	Treatment satisfaction for module 6	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.	An average of 7 weeks after starting the 8-module program
Secondary	Treatment satisfaction for module 7	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.	An average of 9 weeks after starting the 8-module program
Secondary	Treatment satisfaction for module 8	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.	An average of 10 weeks after starting the 8-module program
Secondary	Quantitative program treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction	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.	post-treatment (within 2 weeks of completing the 8-module program)
Secondary	Qualitative program treatment satisfaction	Qualitative feedback about eSense and between-module activities collected by treatment navigators.	through completion of the 8-module program, an average of 10 weeks
Secondary	Change in satisfaction with life	Satisfaction with Life Scale (Diener et al., 1985). Scores range from 5-35, with higher scores reflecting higher levels of life satisfaction.	baseline; post-treatment (within 2 weeks of completing the 8-module program); and 6-month follow-up