The Effectiveness of Online Interpersonal Relationships-Based Pyschoeducation in Increasing Sexual Interest and Arousal in Women With Sexual Interest and Arousal Disorder

May 31, 2024 updated by: Zeynep Dilşah Yılmaz, Marmara University
This study will be conducted to examine the effectiveness of interpersonal relationships-based online psychoeducation developed for women with sexual interest and arousal disorders.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Female sexual interest and arousal disorders are common among sexual dysfunctions. In addition to the physical and mental health of women with sexual interest and arousal disorder, interpersonal relationships are also negatively affected. Based on this relationship, it is predicted that interpersonal relationship-based psychoeducation will be effective in the treatment of sexual interest and arousal disorder.

Interpersonal Relationship Psychotherapy or counseling is a short-term, easy, accessible approach that focuses specifically on interpersonal problems and is based on attachment theory, aiming to reduce depressive symptoms and improve interpersonal functioning.

The number of internet users and the possibilities of access to the internet are increasing significantly all over the world, and online health services via the internet are becoming widespread. Online psychoeducation inevitably takes its place in internet-based applications with technological developments.

In this context, this study will be conducted to increase the sexual interest and arousal levels of women with sexual interest and arousal disorders through online psychoeducation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • A person of female biological sex,
  • Expressing difficulties in sexual interest and arousal (yes to at least three of the following criteria) (questions related to these criteria will be added to the interview form)
  • Decrease/absence in frequency or intensity of sexual activity,
  • Decrease/absence of sexual fantasies/erotic thoughts,
  • Inability to initiate sexual intercourse with their partner,
  • Lack of sexual excitement and pleasure in almost all sexual relationships (about 75%),
  • Decreased/absence of sexual interest/arousal to internal or external sexual erotic stimuli (e.g. written, oral, visual),
  • Decreased/absence of genital or nongenital sensations in almost all sexual relationships (approximately 75%).
  • Low mean scores on the Female Sexual Function Index and Sexual Interest and Desire Inventory-Female scales (mean score on the Female Sexual Function Index below 26.55, mean score on the Sexual Interest and Desire Inventory-Female below 33)
  • Have sufficient knowledge about the use of the Internet,
  • Women who have had a sexual partner for at least 1 year are among the inclusion criteria for this study.

Exclusion Criteria:

  • Becoming pregnant or planning pregnancy during the psychoeducation period,
  • Receive treatment for any sexual dysfunction,
  • Withdrew from the study at any stage of the study,
  • Women who do not attend more than one session of the psychoeducation will not be included in the study (Women who miss the weekly program of the psychoeducation will be allowed a maximum of 2 make-up sessions).

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Women in the experimental group will receive an 8-week online intervention program based on interpersonal relationships. An internet-based intervention application will be developed for this intervention. All interventions will be implemented from this intervention.
Behavioral: Interpersonal relationship-based intervention program
An interpersonal relations-based intervention program will be implemented with an online intervention platform.
Other: Waiting group
After the interventions in the experimental group are completed, the intervention program will be applied to the women in the waiting group.
Behavioral: Interpersonal relationship-based intervention program
An interpersonal relations-based intervention program will be implemented with an online intervention platform.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sexual Interest and Desire Inventory-Female (SIDI-F)
Time Frame: 12 weeks
The inventory is a 13-item inventory developed to measure the level of sexual interest and arousal of women specifically in the last 4 weeks. A total score between 0 and 51 is obtained from the SIDI-F. The cut-off score of the inventory is 33 and 94.7% of the women below this score have a sexual interest and desire disorder.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Female Sexual Distress Scale-Revised
Time Frame: 12 weeks
The 13-item scale, which was developed to evaluate the distress experienced by women with sexual dysfunction, has a 5-point Likert structure. The increase in the scale score indicates an increase in the level of sexual distress in women. The cut-off score of the scale is 11.
12 weeks
Female Sexual Function Index (FSFI)
Time Frame: 12 weeks
The scale was developed to evaluate the sexual problems and sexual functions of individuals in general in the last 4 weeks and consists of 19 questions and 6 subcategories (sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain). The first 2 questions of the scale are related to "sexual desire", questions 3-6 to "sexual arousal", questions 7-10 to "lubrication", questions 11-13 to "orgasm", questions 14-16 to "satisfaction" and questions 17-19 to "pain" subcategories. Questions 1, 2, 15 and 16 are scored between 1 and 5, while the remaining items are scored between 0 and 5. The highest score that can be obtained from the scale is 36 and the lowest score is 2.
12 weeks
Interpersonal Relationship Dimensions Scale
Time Frame: 12 weeks
the dimensions of interpersonal relationships. It has four sub-dimensions: dependency, empathy, trust in others and emotional awareness. The higher the score, the higher the related sub-dimension
12 weeks
System Usability Scale (SUS-TR)
Time Frame: 12 weeks
hardware, mobile devices, online web pages. It is a five-point Likert-type scale with 10 items. Items with odd numbers are scored from one to five, while items with even numbers are scored from five to one. In the scale score calculation, the score obtained from each participant is multiplied by 2.5 and a score between 0-100 is obtained. A high score on the scale indicates that the usability of the system is high.
12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Istanbul University-Cerrahpaşa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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