PerimenopauseNCT04922385
Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause
A study testing Cognitive Behavioural Therapy in people with Perimenopause and Sexual Concerns, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Given the high rates and associated impairment of sexual concerns during the menopausal transition, and specifically during perimenopause, our team has developed a CBT protocol specifically designed to target these prevalent and distressing sexual concerns. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Perimenopause, Sexual Concerns
- What is being tested?
- Cognitive Behavioural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 40-60 years of age;
- peri-menopausal and have had a menstrual period within the previous twelve months as per the STRAW definition (Harlow et al., 2012);
- cut-off score of 26 or lower on the Female Sexual Functioning Index, indicating sexual dysfunction (Wiegel et al., 2005);
- medication stable (e.g., hormone therapy), with no changes in dosing for the previous three months (Green et al., 2019);
- no psychological treatment to address sexual dysfunction and/or sexual concerns within the previous six months; and
- speak, read, and write in English to comprehend testing procedures and written materials in treatment
- living within Canada
Who cannot join
- participants with psychotic disorders, or current substance and/or alcohol dependence; and
- participants who are severely depressed/suicidal at time of the intake assessment.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8P 3R2
Sheryl M Green, PhD, CPsych, 905-522-1155 ext. 33672, sgreen@stjoes.ca
Sheryl M Green, PhD, CPsych
About this study
Given the high rates and associated impairment of sexual concerns during the menopausal transition, and specifically during perimenopause, our team has developed a CBT protocol specifically designed to target these prevalent and distressing sexual concerns. The broad aim of the proposed study is to validate this new protocol in a clinic that provides empirically-supported assessment and intervention services for women with menopause-related symptoms. The primary objective of this study is to evaluate the efficacy of a four-week individual CBT protocol in improving sexual satisfaction and reducing distress during perimenopause. The secondary objective of this study is to evaluate the efficacy of this CBT protocol to improve sexual functioning (e.g., desire, arousal), relationship satisfaction, and body image. Exploratory analyses will examine the impact on this CBT protocol on vasomotor symptoms, depression, and anxiety.
- Conditions
- Perimenopause, Sexual Concerns
- Being tested
- Cognitive Behavioural Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyOther
This study is an open waitlist control study. Eligible participants will be assigned to a treating clinician and will complete 4 weeks of treatment, followed by a post-treatment assessment (2 weeks later). If a treating clinician is not immediately available, participants will be placed on their waitlist for 4 weeks. They will then be assessed after 4 weeks and undergo the 4 week treatment, followed by the post-treatment assessment (2 weeks later).
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Individual 4-week CBT protocol Receives: Other: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Desire Questionnaire (FSDQ)
The FSDQ (Goldhammer \& McCabe, 2011) is a 50-item self-report questionnaire assessing one's experience of and sexual desire for women across six domains: dyadic desire, solitary desire, resistance, positive relationship, sexual self-image, and concern. Total scores range from 50 to 300, with higher scores indicated increased sexual desire.
Measured: 6 weeks
Female Sexual Distress Scale-Revised (FSDS-R)
The FSDS-R (DeRogatis et al., 2008) is a 13-item self-report questionnaire assessing various aspects of sexual distress, with a clinical cut-off score of 11 indicated sexual distress. Scores on the FSDS-R range from 0 to 48, with higher scores indicating greater sexual distress.
Measured: 6 weeks
The Female Sexual Function Index (FSFI)
The FSFI (Rosen et al., 2000) is a six domain measure of female sexual functioning including sexual desire, subjective arousal, lubrication, orgasm, satisfaction, and pain. Scores on the FSFI range from 2-36, which higher scores indicating a greater level of sexual function.
Measured: 6 weeks
Secondary outcomes (8)
The Greene Climacteric Scale (GCS)
The GCS (Greene, 1998) is a self-report questionnaire measuring four menopause-related domains: vasomotor symptoms, depression and anxiety, physical complaints, and sexual concerns. Studies have shown women who score greater than 12 on the GCS are more likely to be menopausal.
Measured: 6 weeks
The Hot Flash Related Daily Interference Scale (HFRDIS)
The HFRDIS (Carpenter, 2001) assesses the degree to which vasomotor symptoms interfere with daily life. Higher scores on the HFRDIS indicate higher interference due to hot flashes and thus, greater impact on quality of life.
Measured: 6 weeks
The Beck Depression Inventory-II (BDI-II)
The BDI-II (Beck et al., 1996) is a self-report questionnaire and one of the most widely used tools for measuring depression. Total scores on the BDI-II range from 0-63, with higher scores indicating increased depressive symptom severity.
Measured: 6 weeks
The Hamilton Anxiety Scale (HAM-A)
The HAM-A (Hamilton, 1959) is a clinician administered questionnaire developed to quantify the severity of anxiety symptomatology and is considered a gold-standard. Total scores on the HAM-A range from 0-56, with greater scores indicating increased anxiety severity.
Measured: 6 weeks
The Couples Satisfaction Index (CSI)
The CSI (Funk \& Rogge, 2007) is a 32-item scale designed to measure one's satisfaction in a relationship. Total scores on the CSI range from 0-81, with higher scores indicating greater couples satisfaction.
Measured: 6 weeks
36-Item Short-Form Health Survey (SF-36)
The SF-36 (Ware \& Sherbourne, 1992) is a 36-item self-administered questionnaire assessing one's perception of overall health and well-being. Higher scores on each domain indicate a more favourable health state in that area.
Measured: 6 weeks
Dresden Body Image Questionnaire (DBIQ)
The DBIQ (Scheffers et al., 2017) is a 35-item self-report questionnaire assessing one's feelings of their physical appearance across five subscales: body acceptance, sexual fulfillment, physical contact, vitality, and self-aggrandizement. Higher score on the DBIQ indicate a more positive body image.
Measured: 6 weeks
Cognitive Flexibility Inventory (CFI)
The CFI (Dennis \& Vander Wal, 2010) is a 20-item self-report questionnaire that assesses three aspects of cognitive flexibility: tendency to perceive difficult situations as controllable, ability to perceive multiple alternative explanations for life occurrences and human behaviour, and ability to generate multiple alternative solutions to difficult situations. Higher scores are indicative of greater cognitive flexibility when encountering stressful situations.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jan 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PerimenopauseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
- Investigators
- Sheryl M Green, PhD, CPsych, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922385
- Sponsor's protocol ID
- CBT-SC-Peri
- Status last verified
- Aug 2022
- First submitted
- 6 Jun 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Green SM, Furtado M, Shea AK, Ballantyne EC, Streiner DL, Frey BN, McCabe RE. Cognitive behavioural therapy for sexual concerns during menopause: evaluation of a four session protocol. J Sex Med. 2025 Jun 29;22(7):1184-1195. doi: 10.1093/jsxmed/qdaf085.
PubMed 40384525Green SM, Furtado M. Cognitive Behavioral Therapy for Sexual Concerns During Perimenopause: A Four Session Study Protocol. Front Glob Womens Health. 2021 Oct 6;2:744748. doi: 10.3389/fgwh.2021.744748. eCollection 2021.
PubMed 34816248
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause
- ClinicalTrials.gov ID
- NCT04922385
- Acronym / sponsor ID
- CBT-SC-Peri
- Conditions
- Perimenopause, Sexual Concerns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 10 Jun 2021 (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.
Given the high rates and associated impairment of sexual concerns during the menopausal transition, and specifically during perimenopause, our team has developed a CBT protocol specifically designed to target these prevalent and distressing sexual concerns. The broad aim of the proposed study is to validate this new protocol in a clinic that provides empirically-supported assessment and intervention services for women with menopause-related symptoms. The primary objective of this study is to evaluate the efficacy of a four-week individual CBT protocol in improving sexual satisfaction and reducing distress during perimenopause. The secondary objective of this study is to evaluate the efficacy of this CBT protocol to improve sexual functioning (e.g., desire, arousal), relationship satisfaction, and body image. Exploratory analyses will examine the impact on this CBT protocol on vasomotor symptoms, depression, and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Other: Cognitive Behavioural TherapyIndividual 4-week CBT protocol |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 40-60 years of age;
- peri-menopausal and have had a menstrual period within the previous twelve months as per the STRAW definition (Harlow et al., 2012);
- cut-off score of 26 or lower on the Female Sexual Functioning Index, indicating sexual dysfunction (Wiegel et al., 2005);
- medication stable (e.g., hormone therapy), with no changes in dosing for the previous three months (Green et al., 2019);
- no psychological treatment to address sexual dysfunction and/or sexual concerns within the previous six months; and
Key exclusion criteria (2 listed)
- participants with psychotic disorders, or current substance and/or alcohol dependence; and
- participants who are severely depressed/suicidal at time of the intake assessment.
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 Behavioural TherapyThis study is an open waitlist control study. Eligible participants will be assigned to a treating clinician and will complete 4 weeks of treatment, followed by a post-treatment assessment (2 weeks later). If a treating clinician is not immediately available, participants will be placed on their waitlist for 4 weeks. They will then be assessed after 4 weeks and undergo the 4 week treatment, followed by the post-treatment assessment (2 weeks later). | Other | CBT |
Primary outcome
Female Sexual Desire Questionnaire (FSDQ)
Time frame: 6 weeks
The FSDQ (Goldhammer \& McCabe, 2011) is a 50-item self-report questionnaire assessing one's experience of and sexual desire for women across six domains: dyadic desire, solitary desire, resistance, positive relationship, sexual self-image, and concern. Total scores range from 50 to 300, with higher scores indicated increased sexual desire.
Female Sexual Distress Scale-Revised (FSDS-R)
Time frame: 6 weeks
The FSDS-R (DeRogatis et al., 2008) is a 13-item self-report questionnaire assessing various aspects of sexual distress, with a clinical cut-off score of 11 indicated sexual distress. Scores on the FSDS-R range from 0 to 48, with higher scores indicating greater sexual distress.
The Female Sexual Function Index (FSFI)
Time frame: 6 weeks
The FSFI (Rosen et al., 2000) is a six domain measure of female sexual functioning including sexual desire, subjective arousal, lubrication, orgasm, satisfaction, and pain. Scores on the FSFI range from 2-36, which higher scores indicating a greater level of sexual function.
8 secondary outcomes
The Greene Climacteric Scale (GCS)
Time frame: 6 weeks
The Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame: 6 weeks
The Beck Depression Inventory-II (BDI-II)
Time frame: 6 weeks
The Hamilton Anxiety Scale (HAM-A)
Time frame: 6 weeks
The Couples Satisfaction Index (CSI)
Time frame: 6 weeks
36-Item Short-Form Health Survey (SF-36)
Time frame: 6 weeks
Dresden Body Image Questionnaire (DBIQ)
Time frame: 6 weeks
Cognitive Flexibility Inventory (CFI)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Derived from this study: PubMed 40384525Green SM, Furtado M, Shea AK, Ballantyne EC, Streiner DL, Frey BN, McCabe RE. Cognitive behavioural therapy for sexual concerns during menopause: evaluation of a four session protocol. J Sex Med. 2025 Jun 29;22(7):1184-1195. doi: 10.1093/jsxmed/qdaf085.
- Derived from this study: PubMed 34816248Green SM, Furtado M. Cognitive Behavioral Therapy for Sexual Concerns During Perimenopause: A Four Session Study Protocol. Front Glob Womens Health. 2021 Oct 6;2:744748. doi: 10.3389/fgwh.2021.744748. eCollection 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sheryl M Green, PhD, CPsych principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy in people with Perimenopause and Sexual Concerns, run by St. Joseph's Healthcare Hamilton at 1 site 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheryl M Green, PhD, CPsych (905-522-1155 ext. 33672, sgreen@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Desire Questionnaire (FSDQ) (time frame: 6 weeks). The study lists 3 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 NCT04922385, which also lists 2 linked publications.
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 23 Aug 2022.