Internet-based Emotion Regulation Intervention for Sexual Health (SHER2)

November 11, 2022 updated by: University of Luxembourg

SHER 2: Internet-delivered Emotion Regulation Skills Training for Sexual Health: a Randomized Controlled Trial

Introduction: Emotion regulation difficulties have been associated with mental disorders and sexual dysfunctions. Traditional face-to-face transdiagnostic emotion regulation interventions have shown positive results for emotional and personality disorders. Only recently have the effects of these interventions on sexual health started to be investigated. Internet-delivered psychological interventions have several advantages over face-to-face interventions, such as cost-effectiveness, accessibility and suitability for people who experience shame because of their stigmatized problematic behaviors and those who avoid seeking help. The aims of the SHER 2 study are: a) determine the efficacy of an Internet-based emotion regulation intervention for sexual health and sexual satisfaction, and; b) explore the effects of the intervention on (1) emotion regulation skills; (2) mental health; (3) sexual self-perception.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
62

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Luxembourg
      • Esch-sur-Alzette, Luxembourg, L-4365
        • University of Luxembourg

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 18 and 65 years of age,
  • fluent in Brazilian Portuguese,
  • self-reported sexual problems, assessed in men by a score of < 21 on the International Index Erectile Function (IIEF) and in women by a score of < 26 on the Female Sexual Function Index (FSFI),
  • in a stable relationship for at least the preceding 3 months.

Exclusion Criteria:

  • medical conditions that can interfere with the outcomes of the intervention, e.g., diabetes, cancer, cardiovascular problems,
  • ongoing psychotherapy.
  • no sexual activity in the previous 4 weeks.

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: None (Open Label)

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: Intervention group
Emotion regulation skills training group
Behavioral: Emotion regulation skills training
The intervention will involve an online emotion-regulation skills training for individuals with sexual problems. It will last for 8 weeks, encompassing psycho-educational and emotion-regulation skills components. Every week participants will gain access to a different intervention module of the training, containing videos, presentation slides, written support material and a recommendation of activities to be completed until the following week of training. Participants are expected to dedicate 30 minutes to one hour per week to complete each module.
No Intervention: waitlist control group
The control group will not receive any intervention during the trial but will be offered the same treatment at the end of the six-months follow-up assessment.

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
Change in Female Sexual Function Index (FSFI) at 6 months
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
this is a 19-item questionnaire for the assessment of sexual functioning in women in domains of sexual functioning (e.g., sexual arousal, orgasm, satisfaction, pain). Answers are provided using a 5-point Likert scale.
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Change in International Index of Erectile Function (IIEF)at 6 months
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
The IIEF is 15-item, self-administered questionnaire for assessing sexual functioning in men. Answers are given on a 6-point Likert scale. The IIEF encompasses five different domains of sexual functioning: erectile function, orgasm function, sexual desire, intercourse satisfaction and overall satisfaction.
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Change in Sexual Quotient (QS) at 6 months
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
The QS is a brief and comprehensive tool composed of 10-questions, which are answered on a scale from 0 (never) to 5 (always). It addresses general sexual function, and stages of the sexual response cycle (desire, arousal, orgasm) and sexual satisfaction.
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

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
Sexual Modes Questionnaire (SMQ) - Automatic Thoughts subscale
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
This self-report scale consists of 30 items in the male version, and 33 items in the female version. Respondents are asked to rate the frequency (from 1 [never] to 5 [always]) with which they have experienced specific automatic thoughts during sexual activity.
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Sexual Self-Schema Scale (SSSS).
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
consists of 30 items assessing respondents' perception of themselves as a sexual person compared to others of the same gender and age. Answers are provided using a 5- point Likert scale ranging from 1 (not at all descriptive of me) to 5 (very much descriptive of me).
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
A 9-item self-report measure used to assess symptoms of depression.
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
General Anxiety Disorder - 7 (GAD-7)
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
A 7-item self-report measure used to assess symptoms of anxiety.
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
the Difficulties in Emotion Regulation Scale (DERS)
Time Frame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
The DERS assesses several facets of emotion regulation, including difficulties relevant to an individual's (a) acceptance of emotional responses, (b) ability to engage in goal-directed behaviour under distress, (c) ability to control impulsive behaviours when distressed, (d) access to emotion regulation strategies, and (e) emotional clarity. Participants rate their degree of agreement with each statement on a scale from 1 (almost never; 0 to 10 percent) to 5 (almost always; 91 to 100 percent).
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

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.
University of Luxembourg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
University of Lausanne
Luxembourg National Research Fund (FNR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claus Vögele, Prof. Dr, Head of Department Department of Behavioural and Cognitive Sciences

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 (Actual)

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.
May 5, 2021

Primary Completion (Actual)

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.
June 30, 2022

Study Completion (Actual)

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.
July 30, 2022

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).
January 29, 2021

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.
March 8, 2021

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.
March 10, 2021

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.
November 14, 2022

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.
November 11, 2022

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.
November 1, 2022

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.
  • SHER 20-029

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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