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Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause

S

St. Joseph's Healthcare Hamilton

Status

Enrolling

Conditions

Sexual Concerns
Perimenopause

Treatments

Other: Cognitive Behavioural Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04922385
CBT-SC-Peri

Details and patient eligibility

About

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.

Enrollment

62 estimated patients

Sex

Female

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

62 participants in 1 patient group

CBT
Experimental group
Description:
Individual 4-week CBT protocol
Treatment:
Other: Cognitive Behavioural Therapy

Trial contacts and locations

1

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Central trial contact

Sheryl M Green, PhD, CPsych

Data sourced from clinicaltrials.gov

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