Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause

August 22, 2022 updated by: Sheryl Green, St. Joseph's Healthcare Hamilton
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sheryl M Green, PhD, CPsych
  • Phone Number: 33672 905-522-1155
  • Email: sgreen@stjoes.ca

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8P 3R2
        • Recruiting
        • St. Joseph's Healthcare Hamilton
        • Sub-Investigator:
          • Benicio N Frey, MD, PhD
        • Contact:
          • Sheryl M Green, PhD, CPsych
          • Phone Number: 33672 905-522-1155
          • Email: sgreen@stjoes.ca
        • Principal Investigator:
          • Sheryl M Green, PhD, CPsych
        • Sub-Investigator:
          • Melissa Furtado, MSc
        • Sub-Investigator:
          • Randi E McCabe, PhD, CPsych
        • Sub-Investigator:
          • Alison Shea, MD, PhD
        • Sub-Investigator:
          • David L Streiner, PhD, CPsych
        • Sub-Investigator:
          • Eleanor Donegan, PhD, CPsych

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 40-60 years of age;
  2. peri-menopausal and have had a menstrual period within the previous twelve months as per the STRAW definition (Harlow et al., 2012);
  3. cut-off score of 26 or lower on the Female Sexual Functioning Index, indicating sexual dysfunction (Wiegel et al., 2005);
  4. medication stable (e.g., hormone therapy), with no changes in dosing for the previous three months (Green et al., 2019);
  5. no psychological treatment to address sexual dysfunction and/or sexual concerns within the previous six months; and
  6. speak, read, and write in English to comprehend testing procedures and written materials in treatment
  7. living within Canada

Exclusion Criteria:

  1. participants with psychotic disorders, or current substance and/or alcohol dependence; and
  2. participants who are severely depressed/suicidal at time of the intake assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBT
Individual 4-week CBT protocol
Other: Cognitive Behavioural Therapy
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Greene Climacteric Scale (GCS)
Time Frame: 6 weeks
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.
6 weeks
The Hot Flash Related Daily Interference Scale (HFRDIS)
Time Frame: 6 weeks
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.
6 weeks
The Beck Depression Inventory-II (BDI-II)
Time Frame: 6 weeks
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.
6 weeks
The Hamilton Anxiety Scale (HAM-A)
Time Frame: 6 weeks
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.
6 weeks
The Couples Satisfaction Index (CSI)
Time Frame: 6 weeks
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.
6 weeks
36-Item Short-Form Health Survey (SF-36)
Time Frame: 6 weeks
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.
6 weeks
Dresden Body Image Questionnaire (DBIQ)
Time Frame: 6 weeks
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.
6 weeks
Cognitive Flexibility Inventory (CFI)
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Joseph's Healthcare Hamilton

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sheryl M Green, PhD, CPsych, St. Joseph's Healthcare Hamilton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBT-SC-Peri

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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