Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause

NCT04922385 | Unknown

• 1 other identifier: CBT-SC-Peri
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 weeks

Secondary Outcomes (8)

• The Greene Climacteric Scale (GCS)

  6 weeks

• The Hot Flash Related Daily Interference Scale (HFRDIS)

  6 weeks

• The Beck Depression Inventory-II (BDI-II)

  6 weeks

• The Hamilton Anxiety Scale (HAM-A)

  6 weeks

• The Couples Satisfaction Index (CSI)

  6 weeks

Study Arms (1)

CBT

EXPERIMENTAL

Individual 4-week CBT protocol

Other: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural Therapy OTHER

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).

CBT

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8P 3R2, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 40384525 DERIVED

• Green 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.

  PMID: 34816248 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sheryl M Green, PhD, CPsych

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheryl M Green, PhD, CPsych

CONTACT

905-522-1155; sgreen@stjoes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, Principal Investigator

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 10, 2021
• Study Start: January 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)