Sexual Risk BehaviorNCT06763016
Distant Group Counseling and Sexual Myths and Attitudes in Young Adults
A study testing Cognitive Behavioural Theory-based group consultation in people with Sexual Risk Behavior and Sexuality, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the impact of distant group counseling through an online platform on sexual myths and sexual attitudes among young adults. The research design and methodology were carefully planned following the Checklist for Reporting Results of Internet E-Surveys online research guide, ensuring that the… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Risk Behavior, Sexuality
- What is being tested?
- Cognitive Behavioural Theory-based group consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2022to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In order to be eligible for participation, individuals had to meet the following criteria: be between 18-29 years of age (This period is defined as 'emerging adulthood' (Arnett, 2000), volunteer for the study, possess the necessary technological resources, and not having received any previous training on sexual health education during data collection.
Who cannot join
- Have a physical or sensory impairment that would affect the ability to use online technology (e.g., history of temporal brain damage, limb loss, hearing loss, etc.), Have a psychiatric diagnosis that would affect decision-making and orientation assessment abilities, Be receiving any professional support that could potentially influence their sexual myths and attitudes when data collection process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Distant Group Counseling on Sexual Myths' and Attitudes in Young Adults: A Randomized Controlled Trial
This study investigates the impact of distant group counseling through an online platform on sexual myths and sexual attitudes among young adults. The research design and methodology were carefully planned following the Checklist for Reporting Results of Internet E-Surveys online research guide, ensuring that the study adhered to robust research protocols. The CONSORT model was applied, including its flowchart, to enhance the transparency of the study and ensure the reproducibility of the research.
The hypotheses formulated for this randomized controlled trial are as follows:
- There is a significant difference in the Sexual Myths Scale (SMS) pretest-posttest-follow-up scores in the intervention group.
- There is a significant difference in the Hendrick Sexual Attitudes Scale (HSAS) pretest-posttest-follow-up scores in the intervention group.
- There is a significant difference in the SMS pretest-posttest-follow-up scores, favoring the intervention group.
- There is a significant difference in the HSAS pretest-posttest-follow-up scores, favoring the intervention group.
Read the detailed description
Data were gathered through pretest, posttest, and follow-up assessments using established scales, including information form, the Sexual Myths Scale (SMS) and the Hendrick Sexual Attitudes Scale (HSAS).
The study followed a randomized controlled trial design, and participants were randomly assigned to either the intervention or control group. The randomization process was conducted using an online randomization tool to eliminate selection bias. Participants were randomized into the control and intervention groups based on balanced distributions of gender, pretest scores from the SMS, and the HSAS. This simple single-blind randomization process was conducted using an online randomization tool to ensure unbiased group allocation. These tools were selected for their relevance to the study's objectives and were adapted for use in an online survey format. Ethical considerations were adhered to throughout the data collection process, and participants provided informed consent before participating in the study.
The intervention consisted of a six-week online group sexual counseling program. Each week, participants in the intervention group attended one 20-minute cognitive-behavioral-based tele-group session through Microsoft Teams, which was supplemented with educational content shared via Instagram.
The intervention sessions focused on various topics, such as sexuality, sexual health, gender roles, and sexual violence. Participants were encouraged to engage in group discussions and complete weekly tasks, which allowed them to interact and reflect on the material presented. The intervention aimed to address and challenge prevalent sexual myths, encourage open discussions about sexuality, and foster healthier sexual attitudes through evidence-based counseling.
To ensure clarity and usability of the surveys, a pilot test was conducted with 10 students to gather feedback on question comprehension and the overall usability of the online platform.
Outcomes:
- Significant reduction in sexual myths in the intervention group, especially in the sexual orientation, masturbation, and sexual satisfaction subdimensions.
- Improvement in sexual attitudes in the intervention group, particularly in sexual orientation and sexual satisfaction, with the control group showing no significant changes.
- Effect size analysis demonstrated a large effect of the intervention, with 38% of the total variance explained by the combined impact of the intervention and time variables.
- Conditions
- Sexual Risk Behavior, Sexuality
- Being tested
- Cognitive Behavioural Theory-based group consultation
- Keywords
- sexual myth, sexual attitude, sexual health, counseling, telemedicine, group therapy
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Theory-based group consultationBehavioural
Also called distant consultation, group consultation, cognitive-behavioral therapy
The sessions focused on various topics, such as sexuality, sexual health, gender roles, and sexual violence. Participants were encouraged to engage in group discussions and complete weekly tasks, which allowed them to interact and reflect on the material presented. The intervention aimed to address and challenge prevalent sexual myths, encourage open discussions about sexuality, and foster healthier sexual attitudes through evidence-based counseling.
The content of the digital interventions was structured on the basis of a semi-structured interactive group counseling. It was supported by sharing content on Instagram, one of the most widely used social media tools of the generation representing.
For three days a week over six weeks, informative posts were shared, asynchronous testing and self-discovery activities were carried out, and a synchronous consultation session was held once a week. The participants were connected to the live broadcast of the research team.
| Study group | Role | What they receive |
|---|---|---|
| Distant group therapy | Experimental | Distant group therapy: The intervention consisted of a six-week online group sexual counseling program. Each week, participants in the intervention group attended one 60-minute cognitive-behavioral-based tele-group session through Microsoft Teams, which was supplemented with educational content shared via Instagram. Receives: Behavioral: Cognitive Behavioural Theory-based group consultation |
| Control | No intervention | Any intervention applied. Following the completion of the research, the need for psychosocial support among the control group participants was assessed, and it was found that none of them in the control group required such support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Myths Scale (first evaluation with posttest)
The scale developed by Gölbaşı et al. (2016) consists of 28 items and has 8 sub-dimensions: sexual orientation (items 1-5), gender (items 6-11), age and gender (items 12-15), sexual behavior (items 16-18), masturbation (items 19-20), sexual violence (items 21-24), sexual intercourse (items 25-26) and sexual satisfaction (items 27-28). Participants mark each item on a five-point Likert-type scale. Scale score is obtained by summing the scores given to each item in the scale. The highest score that can be obtained from the scale is 140 and the lowest score is 28. The items belonging to the sub-dimensions are summed and the score for each sub-dimension is determined. The scale does not have a cut-off point, and a high score indicates that the sexual myths are also high.
Measured: Through intervention completion, an average of 2 month
Sexual Myths Scale (second evaluation with follow up)
The scale developed by Gölbaşı et al. (2016) consists of 28 items and has 8 sub-dimensions: sexual orientation (items 1-5), gender (items 6-11), age and gender (items 12-15), sexual behavior (items 16-18), masturbation (items 19-20), sexual violence (items 21-24), sexual intercourse (items 25-26) and sexual satisfaction (items 27-28). Participants mark each item on a five-point Likert-type scale. Scale score is obtained by summing the scores given to each item in the scale. The highest score that can be obtained from the scale is 140 and the lowest score is 28. The items belonging to the sub-dimensions are summed and the score for each sub-dimension is determined. The scale does not have a cut-off point, and a high score indicates that the sexual myths are also high.
Measured: Through intervention completion, an average of 5 month
Hendrick Sexual Attitudes Scale (first evaluation with posttest)
The Turkish validity and reliability study of this scale, which was developed by Hendrick et al. (2006) to determine sexual attitudes, was conducted by Karaçam et al. The scale consists of four sub-dimensions and includes a total of 23 items. Each item is evaluated between 1-5 points. The questions in the birth control and sharing sub-dimension of the scale are reverse scored and the total score of the scale is not considered appropriate for evaluation. The sub-dimensions of the scale are named as affirmation (items 1-10), birth control (items 11-13), sharing (items 14-18) and instrument (items 19-23). Among these, affirmation refers to indiscriminate sexuality; birth control refers to responsible and tolerant sexuality; sharing refers to idealistic sexuality; and means refers to biological and utilitarian sexuality. High scores obtained from the affirmative and instrumental sub-dimensions of the scale indicate that the individual has an ideal, healthy and balanced sexual attitude.
Measured: Through intervention completion, an average of 2 months
Hendrick Sexual Attitudes Scale (second evaluation with follow up)
The Turkish validity and reliability study of this scale, which was developed by Hendrick et al. (2006) to determine sexual attitudes, was conducted by Karaçam et al. The scale consists of four sub-dimensions and includes a total of 23 items. Each item is evaluated between 1-5 points. The questions in the birth control and sharing sub-dimension of the scale are reverse scored and the total score of the scale is not considered appropriate for evaluation. The sub-dimensions of the scale are named as affirmation (items 1-10), birth control (items 11-13), sharing (items 14-18) and instrument (items 19-23). Among these, affirmation refers to indiscriminate sexuality; birth control refers to responsible and tolerant sexuality; sharing refers to idealistic sexuality; and means refers to biological and utilitarian sexuality. High scores obtained from the affirmative and instrumental sub-dimensions of the scale indicate that the individual has an ideal, healthy and balanced sexual attitude.
Measured: Through intervention completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start10 Jun 2022
- Primary completion10 Nov 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Risk BehaviorStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a single-blind, randomized, factorial experimental type follow-up clinical trial with a control group. The research design and methodology were carefully planned following the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) online research guide, ensuring that the study adhered to robust research protocols. The CONSORT model was applied, including its flowchart, to enhance the transparency of the study and ensure the reproducibility of the research. The study followed a randomized controlled trial (RCT) design, and participants were randomly assigned to either the intervention or control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Beycan Ekitli, PhD., Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763016
- Sponsor's protocol ID
- EgeTrial5
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distant Group Counseling on Sexual Myths' and Attitudes in Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06763016
- Acronym / sponsor ID
- EgeTrial5
- Conditions
- Sexual Risk Behavior, Sexuality
- Keywords
- sexual myth, sexual attitude, sexual health, counseling, telemedicine, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 8 Jan 2025 (actual)
- 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 study investigates the impact of distant group counseling through an online platform on sexual myths and sexual attitudes among young adults. The research design and methodology were carefully planned following the Checklist for Reporting Results of Internet E-Surveys online research guide, ensuring that the study adhered to robust research protocols. The CONSORT model was applied, including its flowchart, to enhance the transparency of the study and ensure the reproducibility of the research.
The hypotheses formulated for this randomized controlled trial are as follows:
- There is a significant difference in the Sexual Myths Scale (SMS) pretest-posttest-follow-up scores in the intervention group.
- There is a significant difference in the Hendrick Sexual Attitudes Scale (HSAS) pretest-posttest-follow-up scores in the intervention group.
- There is a significant difference in the SMS pretest-posttest-follow-up scores, favoring the intervention group.
- There is a significant difference in the HSAS pretest-posttest-follow-up scores, favoring the intervention group.
Detailed description
Data were gathered through pretest, posttest, and follow-up assessments using established scales, including information form, the Sexual Myths Scale (SMS) and the Hendrick Sexual Attitudes Scale (HSAS).
The study followed a randomized controlled trial design, and participants were randomly assigned to either the intervention or control group. The randomization process was conducted using an online randomization tool to eliminate selection bias. Participants were randomized into the control and intervention groups based on balanced distributions of gender, pretest scores from the SMS, and the HSAS. This simple single-blind randomization process was conducted using an online randomization tool to ensure unbiased group allocation. These tools were selected for their relevance to the study's objectives and were adapted for use in an online survey format. Ethical considerations were adhered to throughout the data collection process, and participants provided informed consent before participating in the study.
The intervention consisted of a six-week online group sexual counseling program. Each week, participants in the intervention group attended one 20-minute cognitive-behavioral-based tele-group session through Microsoft Teams, which was supplemented with educational content shared via Instagram.
The intervention sessions focused on various topics, such as sexuality, sexual health, gender roles, and sexual violence. Participants were encouraged to engage in group discussions and complete weekly tasks, which allowed them to interact and reflect on the material presented. The intervention aimed to address and challenge prevalent sexual myths, encourage open discussions about sexuality, and foster healthier sexual attitudes through evidence-based counseling.
To ensure clarity and usability of the surveys, a pilot test was conducted with 10 students to gather feedback on question comprehension and the overall usability of the online platform.
Outcomes:
- Significant reduction in sexual myths in the intervention group, especially in the sexual orientation, masturbation, and sexual satisfaction subdimensions.
- Improvement in sexual attitudes in the intervention group, particularly in sexual orientation and sexual satisfaction, with the control group showing no significant changes.
- Effect size analysis demonstrated a large effect of the intervention, with 38% of the total variance explained by the combined impact of the intervention and time variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a single-blind, randomized, factorial experimental type follow-up clinical trial with a control group. The research design and methodology were carefully planned following the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) online research guide, ensuring that the study adhered to robust research protocols. The CONSORT model was applied, including its flowchart, to enhance the transparency of the study and ensure the reproducibility of the research. The study followed a randomized controlled trial (RCT) design, and participants were randomly assigned to either the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Distant group therapy | Experimental | Behavioral: Cognitive Behavioural Theory-based group consultationDistant group therapy: The intervention consisted of a six-week online group sexual counseling program. Each week, participants in the intervention group attended one 60-minute cognitive-behavioral-based tele-group session through Microsoft Teams, which was supplemented with educational content shared via Instagram. |
| Control | No intervention | –Any intervention applied. Following the completion of the research, the need for psychosocial support among the control group participants was assessed, and it was found that none of them in the control group required such support. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In order to be eligible for participation, individuals had to meet the following criteria: be between 18-29 years of age (This period is defined as 'emerging adulthood' (Arnett, 2000), volunteer for the study, possess the necessary technological resources, and not having received any previous training on sexual health education during data collection.
Key exclusion criteria (1 listed)
- Have a physical or sensory impairment that would affect the ability to use online technology (e.g., history of temporal brain damage, limb loss, hearing loss, etc.), Have a psychiatric diagnosis that would affect decision-making and orientation assessment abilities, Be receiving any professional support that could potentially influence their sexual myths and attitudes when data collection process.
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 Behavioural Theory-based group consultationAlso: distant consultation, group consultation, cognitive-behavioral therapyThe sessions focused on various topics, such as sexuality, sexual health, gender roles, and sexual violence. Participants were encouraged to engage in group discussions and complete weekly tasks, which allowed them to interact and reflect on the material presented. The intervention aimed to address and challenge prevalent sexual myths, encourage open discussions about sexuality, and foster healthier sexual attitudes through evidence-based counseling. The content of the digital interventions was structured on the basis of a semi-structured interactive group counseling. It was supported by sharing content on Instagram, one of the most widely used social media tools of the generation representing. For three days a week over six weeks, informative posts were shared, asynchronous testing and self-discovery activities were carried out, and a synchronous consultation session was held once a week. The participants were connected to the live broadcast of the research team. | Behavioural | Distant group therapy |
Primary outcome
Sexual Myths Scale (first evaluation with posttest)
Time frame: Through intervention completion, an average of 2 month
The scale developed by Gölbaşı et al. (2016) consists of 28 items and has 8 sub-dimensions: sexual orientation (items 1-5), gender (items 6-11), age and gender (items 12-15), sexual behavior (items 16-18), masturbation (items 19-20), sexual violence (items 21-24), sexual intercourse (items 25-26) and sexual satisfaction (items 27-28). Participants mark each item on a five-point Likert-type scale. Scale score is obtained by summing the scores given to each item in the scale. The highest score that can be obtained from the scale is 140 and the lowest score is 28. The items belonging to the sub-dimensions are summed and the score for each sub-dimension is determined. The scale does not have a cut-off point, and a high score indicates that the sexual myths are also high.
Sexual Myths Scale (second evaluation with follow up)
Time frame: Through intervention completion, an average of 5 month
The scale developed by Gölbaşı et al. (2016) consists of 28 items and has 8 sub-dimensions: sexual orientation (items 1-5), gender (items 6-11), age and gender (items 12-15), sexual behavior (items 16-18), masturbation (items 19-20), sexual violence (items 21-24), sexual intercourse (items 25-26) and sexual satisfaction (items 27-28). Participants mark each item on a five-point Likert-type scale. Scale score is obtained by summing the scores given to each item in the scale. The highest score that can be obtained from the scale is 140 and the lowest score is 28. The items belonging to the sub-dimensions are summed and the score for each sub-dimension is determined. The scale does not have a cut-off point, and a high score indicates that the sexual myths are also high.
Hendrick Sexual Attitudes Scale (first evaluation with posttest)
Time frame: Through intervention completion, an average of 2 months
The Turkish validity and reliability study of this scale, which was developed by Hendrick et al. (2006) to determine sexual attitudes, was conducted by Karaçam et al. The scale consists of four sub-dimensions and includes a total of 23 items. Each item is evaluated between 1-5 points. The questions in the birth control and sharing sub-dimension of the scale are reverse scored and the total score of the scale is not considered appropriate for evaluation. The sub-dimensions of the scale are named as affirmation (items 1-10), birth control (items 11-13), sharing (items 14-18) and instrument (items 19-23). Among these, affirmation refers to indiscriminate sexuality; birth control refers to responsible and tolerant sexuality; sharing refers to idealistic sexuality; and means refers to biological and utilitarian sexuality. High scores obtained from the affirmative and instrumental sub-dimensions of the scale indicate that the individual has an ideal, healthy and balanced sexual attitude.
Hendrick Sexual Attitudes Scale (second evaluation with follow up)
Time frame: Through intervention completion, an average of 5 months
The Turkish validity and reliability study of this scale, which was developed by Hendrick et al. (2006) to determine sexual attitudes, was conducted by Karaçam et al. The scale consists of four sub-dimensions and includes a total of 23 items. Each item is evaluated between 1-5 points. The questions in the birth control and sharing sub-dimension of the scale are reverse scored and the total score of the scale is not considered appropriate for evaluation. The sub-dimensions of the scale are named as affirmation (items 1-10), birth control (items 11-13), sharing (items 14-18) and instrument (items 19-23). Among these, affirmation refers to indiscriminate sexuality; birth control refers to responsible and tolerant sexuality; sharing refers to idealistic sexuality; and means refers to biological and utilitarian sexuality. High scores obtained from the affirmative and instrumental sub-dimensions of the scale indicate that the individual has an ideal, healthy and balanced sexual attitude.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Behavioural Theory-based group consultation in people with Sexual Risk Behavior and Sexuality, run by Ege University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Myths Scale (first evaluation with posttest) (time frame: Through intervention completion, an average of 2 month). The study lists 4 primary outcomes in all. 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 23 Jan 2025.