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Completed

NCT Number: NCT04792177

Internet-based Emotion Regulation Intervention for Sexual Health

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.

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Key information

Conditions

Sexual Dysfunction Behavior Emotional Regulation Genital Diseases Mental Disorders Self-Control Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Social Behavior Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Luxembourg

Esch-sur-Alzette, L-4365, Luxembourg

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

University of Luxembourg

Other

Collaborators

  • Linkoeping University
  • Luxembourg National Research Fund
  • University of Lausanne

Registry information

Official study title

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

Acronym: SHER2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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