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

Primary Purpose

Sexual Dysfunction, Sexual Dysfunctions, Psychological

Status
Completed
Phase
Not Applicable
Locations
Luxembourg
Study Type
Interventional
Intervention
Emotion regulation skills training
Sponsored by
University of Luxembourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction focused on measuring internet intervention, emotion regulation, sexual health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Luxembourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

waitlist control group

Arm Description

Emotion regulation skills training 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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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).
Patient Health Questionnaire-9 (PHQ-9)
A 9-item self-report measure used to assess symptoms of depression.
General Anxiety Disorder - 7 (GAD-7)
A 7-item self-report measure used to assess symptoms of anxiety.
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).

Full Information

First Posted
January 29, 2021
Last Updated
November 11, 2022
Sponsor
University of Luxembourg
Collaborators
Luxembourg National Research Fund (FNR), Linkoeping University, University of Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT04792177
Brief Title
Internet-based Emotion Regulation Intervention for Sexual Health
Acronym
SHER2
Official Title
SHER 2: Internet-delivered Emotion Regulation Skills Training for Sexual Health: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Luxembourg
Collaborators
Luxembourg National Research Fund (FNR), Linkoeping University, University of Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Sexual Dysfunctions, Psychological
Keywords
internet intervention, emotion regulation, sexual health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Emotion regulation skills training group
Arm Title
waitlist control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotion regulation skills training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Female Sexual Function Index (FSFI) at 6 months
Description
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.
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Title
Change in International Index of Erectile Function (IIEF)at 6 months
Description
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.
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Title
Change in Sexual Quotient (QS) at 6 months
Description
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.
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Secondary Outcome Measure Information:
Title
Sexual Modes Questionnaire (SMQ) - Automatic Thoughts subscale
Description
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.
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Title
Sexual Self-Schema Scale (SSSS).
Description
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).
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
A 9-item self-report measure used to assess symptoms of depression.
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Title
General Anxiety Disorder - 7 (GAD-7)
Description
A 7-item self-report measure used to assess symptoms of anxiety.
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Title
the Difficulties in Emotion Regulation Scale (DERS)
Description
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).
Time Frame
baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Vögele, Prof. Dr
Organizational Affiliation
Head of Department Department of Behavioural and Cognitive Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Luxembourg
City
Esch-sur-Alzette
ZIP/Postal Code
L-4365
Country
Luxembourg

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://treps.iterapi.se
Description
Related Info

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