Clinical trial NCT04922385: Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause
Official title: Cognitive Behavioural Therapy for Sexual Concerns During Perimenopause
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perimenopause
Sexual Concerns
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Female Sexual Desire Questionnaire (FSDQ)
timeFrame: 6 weeks
measure: Female Sexual Distress Scale-Revised (FSDS-R)
timeFrame: 6 weeks
measure: The Female Sexual Function Index (FSFI)
timeFrame: 6 weeks
Secondary outcomes:
measure: The Greene Climacteric Scale (GCS)
timeFrame: 6 weeks
measure: The Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: 6 weeks
measure: The Beck Depression Inventory-II (BDI-II)
timeFrame: 6 weeks
measure: The Hamilton Anxiety Scale (HAM-A)
timeFrame: 6 weeks
measure: The Couples Satisfaction Index (CSI)
timeFrame: 6 weeks
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: 6 weeks
measure: Dresden Body Image Questionnaire (DBIQ)
timeFrame: 6 weeks
measure: Cognitive Flexibility Inventory (CFI)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Sheryl M Green, PhD, CPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.