Sexual Interest/Arousal DisorderCBCT for SIADNCT06777277
Cognitive-Behavioural Couple Therapy for Sexual Interest/Arousal Disorder
A study testing Cognitive-behavioral therapy in people with Sexual Interest/Arousal Disorder, run by Dalhousie University at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sexual Interest/Arousal Disorder
- What is being tested?
- Cognitive-behavioral therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesCanada
- Study dates
- 7 Jan 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Dalhousie University
Halifax, Nova Scotia, B3H 4R2
Natalie O Rosen, Ph.D., (902) 494-4044, nrosen@dal.ca
- Not yet recruiting
Université de Montréal
Montreal, Quebec, H2V2S9
Sophie Bergeron, Ph.D., 514 343-6111 ext. 5353, sophie.bergeron.2@umontreal.ca
Mylène Desrosiers, M.A., mylene.desrosiers@umontreal.ca
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T1Z4
Katrina Bouchard, Ph.D., 6048754269, katrina.bouchard@ubc.ca
Kate Hunker, B.A., phase.HOLD@ubc.ca
About this study
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.
Read the detailed description
Background and Importance. Sexual health is a fundamental aspect of overall quality of life; a satisfying sexual relationship is associated with 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: persistent difficulties with sexual desire and/or arousal that are personally distressing-Sexual Interest/Arousal Disorder (SIAD9)-affects 7% to 23% of the general population. SIAD is linked to greater healthcare costs, depressive symptoms, and lower relationship satisfaction. Sexual desire-the key component in SIAD-is thought to be embedded in, and influenced by, interpersonal factors, more so for women than for men. Although theoretical and clinical models suggest a significant role for interpersonal processes in SIAD, there is a striking neglect of these factors in available treatments. Couple-based sex therapy is commonly used by clinicians, but no study to date has assessed its efficacy for SIAD. The current proposal builds on our ongoing CIHR-funded work examining interpersonal factors in SIAD, as well as the results of our pilot study.
Aims. The primary aim of this three-centre randomized clinical trial is to test the prediction that a novel cognitive-behavioural couple therapy (CBCT) delivered online will yield significantly greater improvements in primary outcomes of sexual desire and sexual distress for women and individuals with SIAD post-treatment and 6-months later, compared to a waitlist control group. Our secondary aim is to test the prediction that couples receiving CBCT will report greater improvements in sexuality, relationship, and psychological outcomes relative to the control group.
Methods/Approach/Expertise. The investigators will: (1) recruit an inclusive sample of 170 women diagnosed with SIAD via a clinical interview, and their partners; (2) randomize couples to either the 16-session CBCT or a waitlist control group; (3) have couples complete standardized, self-report measures at pre-treatment, post-treatment, and 6-month follow-up as well as approximately every 4 weeks during the treatment period; (4) test the efficacy of CBCT compared to the control group. Procedures will take place at Dalhousie University, Université de Montréal, and the University of British Columbia.
Expected Outcomes. This clinical trial addresses the urgent need for an empirically validated, accessible, couple-based treatment for the most prevalent sexual dysfunction-SIAD. Results will be used by clinicians to provide affected couples with a scientifically-based treatment option that will improve their sexual, relationship and psychological well-being.
- Conditions
- Sexual Interest/Arousal Disorder
- Being tested
- Cognitive-behavioral therapy
- Keywords
- cognitive-behavioral couple therapy, Emotion regulation, Sexual dysfunction, Female sexual interest/arousal disorder, DSM-5
- Medical subject headings
- Emotional Regulation, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CBCT for SIAD | Experimental | 16 sessions of cognitive-behavioural couple therapy. Receives: Other: Cognitive-behavioral therapy |
| Waitlist | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Secondary outcomes (5)
Sexual Satisfaction
The Global Measure of Sexual Satisfaction (GMSEX) assesses overall sexual satisfaction. This scale consists of five items assessing a subjective evaluation of the sexual relationship on five 7-point dimensions: good vs. bad, pleasant vs. unpleasant, positive vs. negative, satisfying vs. unsatisfying, and valuable vs. worthless. Ratings are summed such that possible scores range from 5 to 35, with higher scores indicating greater sexual satisfaction. For the in-treatment surveys, a one-item measure of sexual satisfaction will be used to minimize participant burden. Previously used by our team and showing adequate psychometric properties, the single-item measure asks participants to rate, on a scale of 1 (Very dissatisfied) to 5 (Very satisfied), their answer to the following question: "Since the last survey, how satisfied have you been with your relationship with your partner?".
Measured: 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
It will be assessed with the 16-item Couples Satisfaction Index. Participants will rate their relationship on a number of factors. For example, participants will indicate how happy they are with their relationship, how frequently they disagree with their partner, and how they feel their relationship compares to others. For the in-treatment surveys, participants will fill the four-item shorter version.
Measured: 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
Intimacy will be measured using 9 items on a 7-point scale (1 = not at all, 7 = a lot) where participants rate in general how much they perceived their partner to be responsive, self- and partner-disclosure of private thoughts and feelings and the level of overall intimacy they feel in their relationship.
Measured: 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
It will be measured using the Hospital Anxiety and Depression Scale. This 14-item measure includes two subscales: depression (seven items) and anxiety (seven items). Using a time reference of the last 7 days, participants score each item on a scale from 0 (e.g., Not at all) to 3 (e.g., Most of the time), with higher scores indicating greater severity of symptoms. This measure has been shown to have good reliability and validity.
Measured: 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
Post-treatment satisfaction will be measured using 3 items asking participants to (a) rate on a scale from 0 to 10 their global satisfaction towards the treatment received, (b) whether there is anything else they would like to share about their experience in this treatment, (c) their satisfaction with completing couple therapy via virtual care (on Zoom) on a scale from 0 to 10.
Global ratings of improvement will be measured using 3 items assessing on a scale of 0 (deterioration) to 5 (complete recovery) (a) if there has been an improvement in their sexual desire and/or arousal difficulties following the treatment, (b) if there has been an improvement in distress (negative emotions) about their sex life following the treatment, (c) if there has been an improvement in the overall quality of their sex life following the treatment.
Measured: A. At post-treatment (approximately 18 weeks after baseline) B. At 6-month follow-up (6M after post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start7 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual Interest/Arousal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized clinical trial will evaluate the efficacy of a novel 16-session online CBCT for an inclusive sample of women with SIAD compared to a waitlist control group. Couples in the waitlist control group will complete all questionnaires at the equivalent timepoints as the experimental group. At the end of the 6-month follow-up, waitlist couples will be offered CBCT free-of-charge.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, University of British Columbia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777277
- Sponsor's protocol ID
- 2024-7379
- Other IDs
- 496676
- Acronym
- CBCT for SIAD
- Status last verified
- Nov 2024
- First submitted
- 6 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41840706
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioural Couple Therapy for Sexual Interest/Arousal Disorder
- ClinicalTrials.gov ID
- NCT06777277
- Acronym / sponsor ID
- CBCT for SIAD / 2024-7379
- Conditions
- Sexual Interest/Arousal Disorder
- Keywords
- cognitive-behavioral couple therapy, Emotion regulation, Sexual dysfunction, Female sexual interest/arousal disorder, DSM-5
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Université de Montréal, University of British Columbia
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Importance. Sexual health is a fundamental aspect of overall quality of life; a satisfying sexual relationship is associated with 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: persistent difficulties with sexual desire and/or arousal that are personally distressing-Sexual Interest/Arousal Disorder (SIAD9)-affects 7% to 23% of the general population. SIAD is linked to greater healthcare costs, depressive symptoms, and lower relationship satisfaction. Sexual desire-the key component in SIAD-is thought to be embedded in, and influenced by, interpersonal factors, more so for women than for men. Although theoretical and clinical models suggest a significant role for interpersonal processes in SIAD, there is a striking neglect of these factors in available treatments. Couple-based sex therapy is commonly used by clinicians, but no study to date has assessed its efficacy for SIAD. The current proposal builds on our ongoing CIHR-funded work examining interpersonal factors in SIAD, as well as the results of our pilot study.
Aims. The primary aim of this three-centre randomized clinical trial is to test the prediction that a novel cognitive-behavioural couple therapy (CBCT) delivered online will yield significantly greater improvements in primary outcomes of sexual desire and sexual distress for women and individuals with SIAD post-treatment and 6-months later, compared to a waitlist control group. Our secondary aim is to test the prediction that couples receiving CBCT will report greater improvements in sexuality, relationship, and psychological outcomes relative to the control group.
Methods/Approach/Expertise. The investigators will: (1) recruit an inclusive sample of 170 women diagnosed with SIAD via a clinical interview, and their partners; (2) randomize couples to either the 16-session CBCT or a waitlist control group; (3) have couples complete standardized, self-report measures at pre-treatment, post-treatment, and 6-month follow-up as well as approximately every 4 weeks during the treatment period; (4) test the efficacy of CBCT compared to the control group. Procedures will take place at Dalhousie University, Université de Montréal, and the University of British Columbia.
Expected Outcomes. This clinical trial addresses the urgent need for an empirically validated, accessible, couple-based treatment for the most prevalent sexual dysfunction-SIAD. Results will be used by clinicians to provide affected couples with a scientifically-based treatment option that will improve their sexual, relationship and psychological well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The randomized clinical trial will evaluate the efficacy of a novel 16-session online CBCT for an inclusive sample of women with SIAD compared to a waitlist control group. Couples in the waitlist control group will complete all questionnaires at the equivalent timepoints as the experimental group. At the end of the 6-month follow-up, waitlist couples will be offered CBCT free-of-charge.
| Arm | Type | Receives |
|---|---|---|
| CBCT for SIAD | Experimental | Other: Cognitive-behavioral therapy16 sessions of cognitive-behavioural couple therapy. |
| Waitlist | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyThe 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. | Other | CBCT for SIAD |
Primary outcome
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)
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.
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)
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.
5 secondary outcomes
Sexual Satisfaction
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)
Relationship Satisfaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: A. At post-treatment (approximately 18 weeks after baseline) B. At 6-month follow-up (6M after post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 41840706Shimizu 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy in people with Sexual Interest/Arousal Disorder, run by Dalhousie University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie O Rosen, Ph.D. ((902) 494-4044, nrosen@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.