Internet-based Emotion Regulation Intervention for Sexual Health

NCT04792177 | Completed

• 1 other identifier: SHER 20-029
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction; Sexual Dysfunctions, Psychological

Keywords

internet intervention; emotion regulation; sexual health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Sexual Modes Questionnaire (SMQ) - Automatic Thoughts subscale

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

• Sexual Self-Schema Scale (SSSS).

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

• Patient Health Questionnaire-9 (PHQ-9)

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

• General Anxiety Disorder - 7 (GAD-7)

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

• the Difficulties in Emotion Regulation Scale (DERS)

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

Study Arms (2)

Intervention group

EXPERIMENTAL

Emotion regulation skills training group

Behavioral: Emotion regulation skills training

waitlist control group

NO INTERVENTION

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.

Interventions

Emotion regulation skills training BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Luxembourg: lead
• Luxembourg National Research Fund (FNR): collaborator
• Linkoeping University: collaborator
• University of Lausanne: collaborator

Study Sites (1)

University of Luxembourg

Esch-sur-Alzette, L-4365, Luxembourg

Location

Related Publications (1)

• 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.

  PMID: 38568720 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Emotional Regulation

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Claus Vögele, Prof. Dr

  Head of Department Department of Behavioural and Cognitive Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: March 10, 2021
• Study Start: May 5, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)