Internet-based Emotion Regulation Intervention for Sexual Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Sexual Dysfunction, Sexual Dysfunctions, Psychological

Intervention / Treatment
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* Behavioral: Emotion regulation skills training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Emotion regulation skills training group | Behavioral: Emotion regulation skills training<br>* 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.<br>|
| No Intervention: waitlist control group<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internet intervention, emotion regulation, sexual health