Recruiting

CBT

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT04922385

Conditions

Perimenopause

Sexual Concerns

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioural Therapy

Study Details

Brief 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. 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

Study ID

NCT04922385

Start date

Jan 1, 2021

Status verified date

Aug, 2022

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Mar 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT

Individual 4-week CBT protocol

Interventions

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).

Primary outcome measure

  • Female Sexual Desire Questionnaire (FSDQ) [ Time Frame: 6 weeks ]
  • Female Sexual Distress Scale-Revised (FSDS-R) [ Time Frame: 6 weeks ]
  • The Female Sexual Function Index (FSFI) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Sheryl M Green, PhD, CPsych

905-522-1155sgreen@stjoes.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8P 3R2

Contacts

Sheryl M Green, PhD, CPsych

905-522-1155sgreen@stjoes.ca

Principal Investigator:

Sheryl M Green, PhD, CPsych

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Aug 23, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2022-08-23.