THE INFLUENCE OF COGNITIVE BEHAVIORAL THERAPY IN SEXUAL DYSFUNCTION FEMALE: Randomized Clinical Trial

December 4, 2023 updated by: Centro de Atenção ao Assoalho Pélvico
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Ba
      • Salvador, Ba, Brazil, 40.290-000
        • Recruiting
        • Centro de Atenção ao assoalho pélvico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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:

  1. evaluation session;
  2. sessions of psychoeducation about the CBT model

5 sessions of cognitive restructuring 2 sessions of preventing relapse
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:

  1. evaluation session;
  2. sessions of psychoeducation about the CBT model

5 sessions of cognitive restructuring 2 sessions of preventing relapse
Other: Control
The control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines.
Behavioral: Control therapy
The control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score Function Sexual
Time Frame: one week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Scale Questionary
Time Frame: one week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Atenção ao Assoalho Pélvico

Investigators

  • Principal Investigator: Patricia V Lordelo, PhD, Centro de Atenção ao Assoalho Pélvico - BAHIANA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2015

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 22, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimated)

November 24, 2015

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • U1111-11754978

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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