Recruiting

Cognitive-Behavioural Therapy

Sponsor:

Dalhousie University

Code:

NCT06777277

Conditions

Sexual Interest/Arousal Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-behavioral therapy

Study Details

Brief summary:

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.

Conditions

Sexual Interest/Arousal Disorder

Study ID

NCT06777277

Start date

Jan 7, 2025

Status verified date

Nov, 2024

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • One member of the couple must identify as a cisgender woman, a trans woman, or a gender diverse person assigned female at birth;
  • One member of the couple must meet diagnostic criteria for SIAD;
  • Both partners must be fluent in English or French;
  • Both partners must be in a committed, cohabiting relationship for at least one year (with a partner of any gender/sex).

Exclusion Criteria:

  • Pregnancy, breastfeeding or one year postpartum;
  • No prior sexual experience;
  • Severe relational distress or conflict as determined by baseline measures and interview;
  • Are currently undergoing treatment for SIAD, or are in couple or sex therapy.

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBCT for SIAD

16 sessions of cognitive-behavioural couple therapy.

no intervention: Waitlist

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.

Interventions

Cognitive-behavioral therapy

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.

Primary outcome measure

  • Sexual Desire [ Time Frame: 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 [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Natalie O Rosen, Ph.D.

(902) 494-4044nrosen@dal.ca

Gillian K Hyslop, B.Sc.

902-494-4223rosenlab@dal.ca

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T1Z4

Contacts

Katrina Bouchard, Ph.D.

6048754269katrina.bouchard@ubc.ca

Kate Hunker, B.A.

phase.HOLD@ubc.ca

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada, B3H 4R2

Contacts

Natalie O Rosen, Ph.D.

(902) 494-4044nrosen@dal.ca

More Information

Sponsor

Dalhousie University

Last update posted

Feb 12, 2025

Last verified

Nov, 2024

Keywords

  • cognitive-behavioral couple therapy
  • Emotion regulation
  • Sexual dysfunction
  • Female sexual interest/arousal disorder
  • DSM-5

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dalhousie University on 2025-02-12.