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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02613546
Other study ID # U1111-11754978
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 10, 2015
Est. completion date December 2026

Study information

Verified date December 2023
Source Centro de Atenção ao Assoalho Pélvico
Contact Patricia V Lordelo, Phd
Phone +5571988592400
Email pvslordelo@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is a randomized clinical trial aims to evaluate the influence of cognitive-behavioral psychotherapy (CBT) on quality of life and sexual function of patients with sexual dysfunction. The notion of sexual health for the World Health Organization exceeds the concept of sickness absence, having a subjective well-being of significance in the spheres of self-concept, self-image, interpersonal relationships and sense of self worth. Furthermore, sexual satisfaction and relationship quality of life is also evidenced in many studies. CBT is a brief and focal psychotherapy with proven efficacy in several mental disorders, improving health and quality of life of the treated populations. However, they did not find clinical trials that showed the effectiveness of CBT in Sexual Dysfunctions. This study aims to then fill this gap by evaluating the relationship from the use of techniques of CBT.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date December 2026
Est. primary completion date August 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: - Women aged 18-59 years; - FSFI less than or equal to 26. Exclusion Criteria: - Scores of Beck Scales - moderate or severe; - Prescribing hormone therapy after starting the group.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive behavioral therapy (CBT)
The study group will undergo 10 sessions of guidelines and cognitive behavioral therapy (CBT) about an hour long, once a week. Of these: evaluation session; sessions of psychoeducation about the CBT model 5 sessions of cognitive restructuring 2 sessions of preventing relapse
Control therapy
The control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines.

Locations

Country Name City State
Brazil Centro de Atenção ao Assoalho Pelvico Salvador Ba

Sponsors (1)

Lead Sponsor Collaborator
Centro de Atenção ao Assoalho Pélvico

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score Function Sexual After cognitive behavioral therapy will be held the FSFI questionnaire to assess whether there was change in the score and its domains. one week
Secondary Quality of Life Scale Questionary After cognitive behavioral therapy will be held the SF-36 questionnaire in which assesses the overall quality of life of women. The higher the score the better the quality of life. one week
See also
  Status Clinical Trial Phase
Completed NCT06199219 - Ex-Plissit Model Based Counseling on Sexual Function and Sexual Satisfaction N/A
Active, not recruiting NCT03154801 - Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors (NEUROSEX) N/A
Completed NCT03176069 - Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus) N/A