AzTrials
AzTrials

Sexual DysfunctionSHER2NCT04792177

Internet-based Emotion Regulation Intervention for Sexual Health

A study testing Emotion regulation skills training in people with Sexual Dysfunction and Sexual Dysfunctions, Psychological, run by University of Luxembourg at 1 site in Luxembourg.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Emotion regulation skills training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteLuxembourg
Study dates
5 May 2021to 30 Jul 2022
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Luxembourg1 site

  • University of Luxembourg

    Esch-sur-Alzette, L-4365

Other trials in Luxembourg

About this study

Official title: 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.

Being tested
Emotion regulation skills training
Keywords
internet intervention, emotion regulation, sexual health
Medical subject headings
Sexual Dysfunction, Physiological, Sexual Dysfunctions, Psychological, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotion regulation skills trainingBehavioural

    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.

Study groups in NCT04792177
Study groupRoleWhat they receive
Intervention groupExperimentalEmotion regulation skills training group
Receives: Behavioral: Emotion regulation skills training
waitlist control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Female Sexual Function Index (FSFI) at 6 months

    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.

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

  2. Change in International Index of Erectile Function (IIEF)at 6 months

    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.

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

  3. Change in Sexual Quotient (QS) at 6 months

    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.

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

Secondary outcomes (5)

  1. Sexual Modes Questionnaire (SMQ) - Automatic Thoughts subscale

    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.

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

  2. Sexual Self-Schema Scale (SSSS).

    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).

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

  3. Patient Health Questionnaire-9 (PHQ-9)

    A 9-item self-report measure used to assess symptoms of depression.

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

  4. General Anxiety Disorder - 7 (GAD-7)

    A 7-item self-report measure used to assess symptoms of anxiety.

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

  5. the Difficulties in Emotion Regulation Scale (DERS)

    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).

    Measured: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start5 May 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jul 2022

Resources

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
Model description
Participants are assigned to one of two groups for the duration of the study. 50% of participants will be assigned to the intervention group while the other 50% will be assign to a waitlist control condition. The waitlist group will have access to the intervention after 6 months.
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792177
Sponsor's protocol ID
SHER 20-029
Acronym
SHER2
Status last verified
Nov 2022
First submitted
29 Jan 2021
Last updated
14 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jobim Fischer V, Rossato Holz M, Billieux J, Andersson G, Vogele C. Web-Based Emotion Regulation Training for Sexual Health: Randomized Controlled Trial. JMIR Form Res. 2024 Apr 3;8:e50850. doi: 10.2196/50850.

    PubMed 38568720

Questions about this trial

What is this clinical trial studying?

A study testing Emotion regulation skills training in people with Sexual Dysfunction and Sexual Dysfunctions, Psychological, run by University of Luxembourg at 1 site in Luxembourg.

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 4 inclusion and 3 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 14 Nov 2022. 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 Luxembourg. 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?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792177, which also lists 1 linked publication.

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 14 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in