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CBCT for SIAD
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Canadian Institutes of Health Research
interventional
170
1 country
3
Study Start
January 7, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Sexual health is a fundamental aspect of quality of life; a satisfying sexual relationship is linked to better physical, psychological, and relationship health and well-being. In fact, people who maintain a satisfying, active sex life over time live longer than those who report lower sexual frequency and satisfaction. Yet problems with sexual function are extremely common, especially for women: chronic difficulties with sexual desire and/or arousal that are personally upsetting-Sexual Interest/Arousal Disorder (SIAD)-affects 7% to 23% of the general population. SIAD is linked to more healthcare costs, depressive symptoms and anxiety, and lower relationship satisfaction. Experts suggest that relationship factors play a critical role in SIAD and couple-based sex therapy is a common approach used by clinicians. However, there are no treatment options available for couples that have been tested in research to confirm that they work. The goal of this three-centre randomized clinical trial is to evaluate the efficacy of a novel 16-session cognitive-behavioural couple therapy (CBCT), offered online to increase accessibility, for an inclusive sample of women with SIAD compared to a waitlist control group. The investigators expect that, compared to a waitlist control group, CBCT will lead to greater improvements in SIAD symptoms (e.g., higher sexual desire/arousal, lower sexual distress) and better sexual, relational, and psychological adjustment for both partners at post-treatment and 6-months later. Given that less than a third of those affected by SIAD access treatment, this study addresses the urgent need for an accessible couple-based treatment for the most common sexual dysfunction. Results will be used by clinicians to provide couples with a scientifically based, accessible treatment option, that will improve their sexual, relationship, and psychological health.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 6, 2025
Actual (reported)January 7, 2025
Actual (reported)January 15, 2025
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Sexual Desire
As a core symptom of SIAD, partner-focused dyadic sexual desire will be assessed using the 7-item subscale of the Sexual Desire Inventory. This subscale measures interest in sexual activity, including one's thoughts on approaching or being responsive to sexual stimuli with a partner, in a Likert-type response format (e.g., 1 = not at all, 7 = a lot). Higher scores indicate greater partner-focused dyadic sexual desire. For the in-treatment surveys, a shorter version of the Sexual Desire Inventory-2, including two items, will be used to minimize participant burden. This version has been used in prior studies and showed adequate psychometric properties.
A. At baseline (after enrolment in the study) B. During treatment (approximately 4, 8, 12 and 16 weeks after baseline) C. At post-treatment (approximately 18 weeks after baseline) D. At 6-month follow-up (6M after post-treatment)
Sexual Distress
As a core symptom of SIAD, sexual distress will be measured with the 5-item Sexual Distress Scale-SF (SDS-SF). Using a 5-point Likert scale, participants rate how frequently (e.g., 1 = never, to 5 = always) they experience an emotion or sexuality related problem. These items showed greatest function at the item level, greatest contribution to the scale's reliability, and good capacity to discriminate between participants with distressing sexual problems and those without distressing sexual problems. This measure is valid regardless of whether participants are sexually active. For the in-treatment surveys, the three-item version of the SDS-SF will be used to minimize participant burden. It has been used in previous studies and showed adequate psychometric properties.
A. At baseline (after enrolment in the study) B. During treatment (approximately 4, 8, 12 and 16 weeks after baseline) C. At post-treatment (approximately 18 weeks after baseline) D. At 6-month follow-up (6M after post-treatment)
Sexual Satisfaction
A. At baseline (after enrolment in the study) B. During treatment (approximately 4, 8, 12 and 16 weeks after baseline) C. At post-treatment (approximately 18 weeks after baseline) D. At 6-month follow-up (6M after post-treatment)
Relationship Satisfaction
A. At baseline (after enrolment in the study) B. At post-treatment (approximately 18 weeks after baseline) C. At 6-month follow-up (6M after post-treatment)
Relationship intimacy
A. At baseline (after enrolment in the study) B. At post-treatment (approximately 18 weeks after baseline) C. At 6-month follow-up (6M after post-treatment)
Psychological adjustment
A. At baseline (after enrolment in the study) B. At post-treatment (approximately 18 weeks after baseline) C. At 6-month follow-up (6M after post-treatment)
Post-treatment satisfaction and participant global ratings of improvement
A. At post-treatment (approximately 18 weeks after baseline) B. At 6-month follow-up (6M after post-treatment)
16 sessions of cognitive-behavioural couple therapy.
Description: The investigators selected a waitlist control comparison as the first step to establishing efficacy of the CBCT because there are no existing empirically validated couple-based treatments available for SIAD.
The intervention will be delivered in 16, 60-minute sessions (1st session 90 mins). The treatment manual was informed by a 12-session (75 min each) CBCT developed by our team for genito-pelvic pain. The SIAD manual focuses on empirically supported interpersonal factors relevant to SIAD, informed by the Interpersonal Emotion Regulation Model of women's sexual dysfunction. The goals of the CBCT are to: (1) re-conceptualize low sexual desire/arousal as multidimensional in which both partners affect and are affected by the SIAD symptoms (2) modify and/or accept those factors that are associated with low sexual desire/arousal to increase adaptive coping, facilitate sexual desire/arousal, and reduce sexual distress, (3) as per our theoretical model, improve couple interactions related to sexuality (e.g., communication, intimacy) via enhanced emotion regulation, and (4) consolidate skills.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of British Columbia
Vancouver, British Columbia, V6T1Z4, Canada
Dalhousie University
Halifax, Nova Scotia, B3H 4R2, Canada
Shimizu JPK, Bouchard KN, Bergeron S, Girouard A, Popova N, Rosen NO. Helping with Outcomes for Low Desire (HOLD): Study protocol for a randomized clinical trial assessing a cognitive-behavioral couple therapy for sexual interest/arousal disorder. Trials. 2026 Mar 16;27(1):315. doi: 10.1186/s13063-026-09619-1.
First Submitted
January 6, 2025
Contact the study team to confirm eligibility.
Université de Montréal
Montreal, Quebec, H2V2S9, Canada
First Posted
January 15, 2025
Study Start
January 7, 2025
Actual (reported)Primary Completion
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 12, 2025
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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