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

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: Completed
• Conditions: Sexual Dysfunction; Sexual Dysfunctions, Psychological
• Intervention / Treatment: Behavioral: Emotion regulation skills training

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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	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	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

Outcome Measure	Measure Description	Time Frame
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.	baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
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).	baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Patient Health Questionnaire-9 (PHQ-9)	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)	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)	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

• Sponsor: University of Luxembourg
• Collaborators: Linkoeping University; University of Lausanne; Luxembourg National Research Fund (FNR)
• Investigators: Principal Investigator: Claus Vögele, Prof. Dr, Head of Department Department of Behavioural and Cognitive Sciences

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: sexual health; emotion regulation; internet intervention
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID 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