Sexual DysfunctionsNCT02613546
THE INFLUENCE OF COGNITIVE BEHAVIORAL THERAPY IN SEXUAL DYSFUNCTION FEMALE: Randomized Clinical Trial
A study testing Cognitive behavioral therapy (CBT) in people with Sexual Dysfunctions, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunctions
- What is being tested?
- Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Sep 2015to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-59 years;
- FSFI less than or equal to 26.
Who cannot join
- Scores of Beck Scales - moderate or severe;
- Prescribing hormone therapy after starting the group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, 40.290-000
Patricia V Lordelo, Phd, +5571988592400, pvslordelo@hotmail.com
About this study
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.
- Conditions
- Sexual Dysfunctions
- Being tested
- Cognitive behavioral therapy (CBT), Control therapy
- Keywords
- cognitive-behavioral psychotherapy, Sexual Dysfunctions, Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
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 therapyBehavioural
The control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Control therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Secondary outcomes (1)
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start10 Sep 2015
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia V Lordelo, PhD, Principal investigator, Centro de Atenção ao Assoalho Pélvico - BAHIANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613546
- Sponsor's protocol ID
- U1111-11754978
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2015
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE INFLUENCE OF COGNITIVE BEHAVIORAL THERAPY IN SEXUAL DYSFUNCTION FEMALE: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02613546
- Acronym / sponsor ID
- U1111-11754978
- Conditions
- Sexual Dysfunctions
- Keywords
- cognitive-behavioral psychotherapy, Sexual Dysfunctions, Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT) | Experimental | 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 |
| Control | Other | Behavioral: Control therapyThe control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18-59 years;
- FSFI less than or equal to 26.
Key exclusion criteria (2 listed)
- Scores of Beck Scales - moderate or severe;
- Prescribing hormone therapy after starting the group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Cognitive behavioral therapy (CBT) |
| Control therapyThe control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines. | Behavioural | Control |
Primary outcome
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.
1 secondary outcome
Quality of Life Scale Questionary
Time frame: one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia V Lordelo, PhD principal investigator
Centro de Atenção ao Assoalho Pélvico - BAHIANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) in people with Sexual Dysfunctions, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia V Lordelo, Phd (+5571988592400, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score Function Sexual (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.