Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2022

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: CBT
    • Individual 4-week CBT protocol

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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 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.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Joseph’s Healthcare Hamilton
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sheryl Green, Clinical Psychologist, Principal Investigator – St. Joseph’s Healthcare Hamilton
  • Overall Official(s)
    • Sheryl M Green, PhD, CPsych, Principal Investigator, St. Joseph’s Healthcare Hamilton
  • Overall Contact(s)
    • Sheryl M Green, PhD, CPsych, 905-522-1155, sgreen@stjoes.ca

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