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

Sponsor
Centro de Atenção ao Assoalho Pélvico (Other)
Overall Status
Unknown status
CT.gov ID
NCT02613546
Collaborator
(none)
34
1
2
14
2.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive behavioral therapy (CBT)
  • Behavioral: Control therapy
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Mar 1, 2016
Anticipated Study Completion Date :
Nov 1, 2016

Arms and Interventions

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: evaluation session; 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: evaluation session; 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.

Outcome Measures

Primary Outcome Measures

  1. Score Function Sexual [one week]

    After cognitive behavioral therapy will be held the FSFI questionnaire to assess whether there was change in the score and its domains.

Secondary Outcome Measures

  1. Quality of life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro de Atenção ao Assoalho Pelvico Salvador Ba Brazil 40.290-000

Sponsors and Collaborators

  • Centro de Atenção ao Assoalho Pélvico

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centro de Atenção ao Assoalho Pélvico
ClinicalTrials.gov Identifier:
NCT02613546
Other Study ID Numbers:
  • U1111-11754978
First Posted:
Nov 24, 2015
Last Update Posted:
Dec 3, 2015
Last Verified:
Nov 1, 2015
Keywords provided by Centro de Atenção ao Assoalho Pélvico

Study Results

No Results Posted as of Dec 3, 2015