NCT02613546

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2015Dec 2026

Study Start

First participant enrolled

September 10, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

10.9 years

First QC Date

November 22, 2015

Last Update Submit

December 4, 2023

Conditions

Keywords

cognitive-behavioral psychotherapySexual DysfunctionsWomen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of Life Scale Questionary

    one week

Study Arms (2)

Cognitive behavioral therapy (CBT)

EXPERIMENTAL

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)

Control

OTHER

The control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines.

Behavioral: Control therapy

Interventions

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

Cognitive behavioral therapy (CBT)
Control therapyBEHAVIORAL

The control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines.

Control

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-59 years;
  • FSFI less than or equal to 26.

You may not qualify if:

  • Scores of Beck Scales - moderate or severe;
  • Prescribing hormone therapy after starting the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Patricia V Lordelo, PhD

    Centro de Atenção ao Assoalho Pélvico - BAHIANA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia V Lordelo, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2015

First Posted

November 24, 2015

Study Start

September 10, 2015

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations