Strengths and limitations of this study

  • To the best of our knowledge, this is the first evaluation of an internet-based emotion regulation intervention for sexual health.

  • The intervention protocol was developed encompassing both sex therapy and emotion regulation components already used for other mental disorders.

  • Immediate and long-term (6 months) assessment of intervention effects on sexual health, mental health, and self-schema.

Limitation

  • Participant assessments will be conducted via self-report questionnaires.

  • Self-selection of participants.

Introduction

Epidemiological studies suggest that 40–45% of adult women and 20–30% of adult men of the general population fulfill the criteria for at least one sexual dysfunction at one point in time during their lives [1]. Sexual dysfunctions (i.e., difficulties in the ability to respond sexually or to obtain sexual pleasure [2];) are multifactorial and involve physiological, affective, interpersonal, and psychological, context-related-factors [3]. They can only be understood by considering the constituent factors of sexual health, such as the experience and expression of thoughts, fantasies, desires, beliefs, attitudes, values, behaviors, and practices [4]. These factors may play a pivotal role in the development of sexual problems, and in maintaining sexual dysfunction in the long term [5].

One important factor is emotion regulation (ER), defined as the way in which emotions are generated, experienced, and used [6]. Such processes include emotional awareness (attention, differentiation, and labeling of emotions), expression (suppression versus expression of emotions), and experience (accessing and reflecting on one’s emotions and their consequences [6]). Emotion regulation difficulties have been associated with unhealthy co** strategies, mental disorders [7], and with difficulties in the sexual response cycle of both men and women (arousal, lubrication, orgasm, pain, erection and ejaculation [8, 9]).

A range of emotion regulation interventions have been shown as efficacious in the treatment of emotional and personality disorders, e.g., the Unified Protocol (UP [10]) and the Affect Regulation Training (ART [11]). In view of the high prevalence rates of emotion regulation deficits and comorbidity of sexual dysfunctions with other mental disorders [12], such interventions might also be helpful in treating sexual dysfunctions.

Recently, two studies tested an in vivo transdiagnostic approach to sexual problems. Parsons et al. [13] conducted a pilot study with 13 HIV-positive gay and bisexual men reporting high rates of sexual compulsivity. After up to ten intervention sessions, improvements were observed in all psychological outcomes, including sexual compulsivity, depression, and anxiety, as well as decreases in drug use and HIV risk behaviors. Nonetheless, the initial small sample size (n = 13) and the fact that only 4 participants completed all sessions limit the conclusions that can be drawn from these results. De Ornelas Maia et al. [14] conducted an intervention to enhance quality of life and sexual functioning in unipolar depressive disorder or anxiety disorder participants. Both intervention groups (UP group intervention + pharmacological treatment, and pharmacological treatment only group) showed significant improvements in quality of life, anxiety, and depression. Improvements in sexual functioning was also noticed; the effect size was larger for sexual dysfunction in the non-depressed group (d = 2.62) than in the depressed group (d = 1.04).

Although progress has been made in the psychological treatment of sexual problems, feelings of shame in meetings with physical face-to-face contact limit their dissemination. In contrast, internet-delivered interventions may offer a greater degree of perceived privacy and, therefore, appeal to those who otherwise would avoid seeking help. Additional advantages of internet-delivered interventions concern their cost-effectiveness and accessibility [15] and the possibility for patients to deal with their problem in their home environment [16].

Internet-delivered psychological interventions vary in the way they are delivered. They are usually composed of a package of comprehensive self-help material with which the patient receives information and exercises on a weekly basis [17]. The content is delivered in the form of text, video, or audio, which is presented on a platform together with homework assignments and interactions with a clinician and/or automated support functions (i.e., self-guided treatments). Overall, there is evidence that I-therapy is more effective than no intervention and, more importantly, similar in efficacy to face-to-face treatments [18].

Internet-delivered treatments have been applied in the area of sexual health care as well. Some studies have examined the effects of addressing sexual concerns using I-therapy. In a pilot study Van Diest et al. [19] tested an Internet-delivered protocol for different sexual dysfunctions and found improvements in sexual functioning in 67% of the participants (N = 39), with improvements maintained at 1-month follow-up. Van Lankveld et al. [20] found that treatment was superior compared to waitlist control in an Internet-delivered sex therapy for erectile dysfunction. Similarly, Andersson et al. [21] found that 7-week internet-delivered cognitive behavior therapy significantly improved erectile performance when compared to an online discussion control group.

Recently, two studies have been registered aiming at investigating the effects of I-therapy on sexual health, one comparing two Internet-based interventions (cognitive behavior therapy and mindfulness-based therapy) for the treatment of low sexual desire in women [22] and one analyzing the feasibility of a brief online psycho-educational intervention for sexual interest/arousal disorder [23]. However, there is a lack of studies examining the efficacy of Internet-delivered emotion regulation psychological interventions for sexual health.

Aim

The first aim of the SHER 2—TREpS study is to determine the efficacy of an emotion regulation intervention for improving sexual health and sexual satisfaction.

The second aim is to explore the effects of the intervention on factors potentially mediating its effects, i.e., (1) emotion regulation skills, (2) anxiety and depression symptomatology, and (3) sexual self-perception (sexual self-schema and automatic thoughts during sexual activity).

Research questions

In more detail, the following research questions will be addressed:

  1. 1.

    Does the TREpS intervention increase sexual health and sexual satisfaction?

  2. 2.

    Does the TREpS intervention increase emotion regulation skills?

  3. 3.

    Does the TREpS intervention decrease anxiety/depression symptomatology?

  4. 4.

    Does the TREpS intervention improve sexual self-schema and decrease negative thoughts during sexual activity?

Methods

Design

A randomized controlled trial will be conducted. Participants will be allocated to either group 1 (intervention) or group 2 (waitlist).

Randomization will be performed prior to the enrolment of study participants. Two separate block randomization lists will be created (one per sex) via sealed envelope and participants with baseline completed will be allocated either on the TREPS intervention group or to a waitlist control group. The allocation will be conducted by a clinical psychologist with no involvement in the project and the intervention provider will have no influence on participants allocation. Analyses will be conducted and presented following the Consolidated Standards of Reporting Trials (CONSORT) statement [24, 25].

Participants

Inclusion criteria

Individuals are eligible for participation if they meet the following criteria: (1) between 18 and 65 years of age, (2) fluent in Brazilian Portuguese, (3) 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), and (4) in a stable relationship for at least the preceding 3 months.

Exclusion criteria

Volunteers will be excluded if they report (1) medical conditions that can interfere with the outcomes of the intervention, e.g., diabetes, cancer, cardiovascular problems, or (2) ongoing psychotherapy.

Recruitment

Recruitment will be conducted via the internet only. Advertisements concerning the project and invitations to take part in the study will be implemented using social media, targeting the Brazilian Portuguese speaking population. Additionally, participants of a previous online survey (SHER 1- study) who volunteered to participate in future studies will also be contacted.

Participants’ information and consent

Written informed consent will be obtained electronically from all participants before any data collection ensues. The information and consent form will explain the objectives of the study, that there is no incentive for taking part, and that privacy and confidentiality is guaranteed as well as the right to withdraw from the study at any point in time without giving reasons or any negative consequences. There is no foreseeable risk associated with participation. Potential burdens from taking part in the study include the possible inconvenience from spending more time with one activity or feeling uncomfortable because of some questions or materials. In case participants would feel upset as a result of answering some of the questions or being involved in some of the intervention activities, they will have the opportunity to contact the research team, with or without disclosing their identity. In case of unexpected findings (for example concerning mental health), participants will be informed, supported, and guided by the research team.

If participants have any questions or wish to be informed of the results of the project and relevant publications, they are given with the opportunity to contact the principal investigator through the contact information provided in the online survey.

Sample size

Considering the number of variables of the study (with a power of .80 or greater and with a significance level set at α = .05), the minimum sample size needed to find meaningful differences in sexual health is 102 participants (51 in the intervention and 51 the control group [26]). Considering gender differences, we will aim to obtain twice this sample size (N = 204), i.e., 102 participants per gender.

Outcomes

Primary outcome

  1. 1)

    Improvements in self-reported sexual health from baseline to 6-month follow-up.

    Secondary outcomes

  2. 2)

    Emotion regulation improvement (from baseline to 6-month follow-up).

  3. 3)

    Reduction in automatic thoughts during sexual activity (from baseline to 6-month follow-up).

  4. 4)

    Reduction in anxiety scores (from baseline to 6-month follow-up).

  5. 5)

    Reduction in depression scores (from baseline to 6-month follow-up).

  6. 6)

    Improvement in sexual self-schema (from baseline to 6-month follow-up).

Measurements

Measurements will be undertaken at 3 time-points in each group: baseline, end of intervention, and 6-month follow up.

Sexual health

Sexual health will be assessed using four questionnaires, two of which concern self-perception as a sexual person, thoughts, and emotions during sexual activity and two questionnaires on sexual function.

Female participants will be asked to complete the Female Sexual Function Index (FSFI [27]) and the Sexual Quotient- female version (SQ-f [28]), while male participants will be asked to answer the International Index of Erectile Function (IIEF [29]) and the Sexual Quotient- male version (SQ-m [30]).

A) Female Sexual Function Index (FSFI) [27]: 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. Hentschel et al. [31] translated and validated the he FSFI into Portuguese, showing good internal consistency both for the evaluation of the total scale (α = .92) and for specific domains (desire = .67; excitation = .80; lubrication = .89; orgasm = .87; satisfaction = .85; pain = .86).

B) International Index of Erectile Function (IIEF) [29]. 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. Ferraz and Cicconelli [32] translated and adapted the scale to Brazilian Portuguese. Its psychometric properties were assessed by Gonzáles et al. [33], showing good internal consistency for both the full scale (α = .89) and the specific domains (erectile function = .86; orgasmic function = .63; sexual desire = .77; sexual satisfaction = .60; general satisfaction = .73).

C) Sexual Modes Questionnaire (SMQ) – Automatic Thoughts subscale [34]. 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. The psychometric properties of the Brazilian adapted version were evaluated by Lucena [35], with an internal consistency of α = .92 and retest reliability of r = .8 (p < .05) for the female version and α = .95 and r = .82 (p < .05) for internal consistency and reliability, respectively, for the male version.

D) Sexual Quotient (QS) [28, 30]. 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. The female version showed excellent internal consistency, both for the questionnaire as a whole (α = .98) and for each of its domains (all with α ≥ .9) [28]. The male version showed satisfactory internal consistency for the questionnaire as a whole (α = .6) and for the separate domains (all with α ≥ .6).

E) Sexual Self-Schema Scale (SSSS). Originally developed by Hill [36], the Brazilian version of the 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). It has good test-retest reliability (r = .6, p < .05) and internal consistency (scale total Cronbach's alpha of .8, ranging from .61 to .85 for the three factors [35]).

Mental health assessment

for the assessment of mental health problems participants will complete the Patient-Heath Questionnaire (PHQ-9) and the Generalized Anxiety Disorder 7 (GAD-7). Both instruments are frequently used self-report diagnostic tools for the assessment of mental disorders.

a) The Patient Health Questionnaire-9 (PHQ-9) is a nine-item screening instrument, which also provides an assessment of the severity of depression. The diagnostic validity of the tool has been established for its English language version [37] as well as for the Brazilian version [38]. The questionnaire has good psychometric properties (77.5% sensitivity and 86.7% specificity) [39].

b) The General Anxiety Disorder – 7 (GAD-7) is a brief self-report measure specifically developed to assess Generalized Anxiety Disorder [40]. It has good reliability, as well as criterion, construct, factorial, and procedural validity. The Brazilian version has good internal consistency and reliability with Cronbach’s alpha of α = .916 and a rho composite reliability coefficient of ρ = .909 [41].

Emotion regulation assessment

For the assessment of emotion regulation, the Difficulties in Emotion Regulation Scale (DERS) will be used. The DERS is an empirically grounded assessment instrument measuring emotional regulation using a multidimensional framework, developed by Gratz and Roemer [42], and validated in Brazil by Miguel et al. [43] with its psychometric properties confirmed (α = .94 for the overall scale, ranging from 0.79 to 0.88 on subscales [44]). 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 behavior under distress, (c) ability to control impulsive behaviors 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%) to 5 (almost always; 91 to 100%).

Intervention

The intervention will involve an online emotion-regulation skills training for individuals with sexual problems. The protocol was developed based on existing emotion-regulation therapies [7, 10, 11, 45, 46]. 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 min to 1 h per week to complete each module.

The intervention is structured as shown in Table 1.

Table 1 Summary of intervention modules
Full size table

Control

The control group will not receive any intervention during the trial but will be offered the same treatment at the end of the 6 months follow-up assessment (waitlist-control).

Data collection and management

All necessary precautions will be taken to maintain the confidentiality of study participants. Information collected will be pseudonymized so that individual identities cannot be revealed. For each study participant, a unique identifier will be generated and associated with his/her data records. The identifier key list containing personal identifiers (name, address, phone number, etc.) will only be accessible to the investigators of the study. The key list will be stored in locked cabinet in the premises of the researcher’s institution (University of Luxembourg) and will be destroyed after the trial has come to an end.

The servers are located in a locked computer room where only authorized personnel form the University’s IT department have access using cards and keys. Sensitive data (contact information, journals, conversations, answers to assignments) will be stored encrypted in the database, using algorithms such as AES256 with secret keys etc.; furthermore, it is not possible to establish a link between this stored data and individual users by access to the database.

All data communication between servers and users is encrypted (via TLS/https). Each participant will be assigned a random user code (four digits followed by four letters), which is used by the researcher carrying out the intervention to identify participants during the intervention. All communication related to the treatment takes place on the platform, after logging in, like in bank systems, so no confidential information is sent unencrypted by e-mail. The software on the servers is kept up to date. Backup of data is taken regularly and will be kept in a separate location from the live servers. Consent forms will contain participant’s signature and his/her unique identification number.

The controlled access to the intervention platform will guarantee the confidentiality of personal identity and the right to the protection of personal data and privacy of individuals involved in the data collection. The integrity of the study will be monitored by the Thesis Supervision Committee under which the study is being conducted.

Study results will be presented as aggregated data, with no personal information. No reference to individual participants will be made in a way that allows for identification.

Data analysis

Data will be analyzed based on three measurements: baseline, end of intervention, and follow-up 6 months later. Analyses will be conducted to ascertain the balance on the measured covariates between the treatment and the control group.

To avoid potential post-treatment complications, such as noncompliance behavior after treatment assignment, the standard intention-to-treat estimate will be performed. To assess mean differences in the different domains (sexual health, emotion regulation, mental health, and sexual self-perception) over time and between groups, repeated-measures analysis of variance will be performed, with time (assessment point) as the within-subject factor, and intervention (group) as the between-subject factor. In case of violation of normality, changes over time in groups will be assessed with related-samples Wilcoxon tests. Multiple-imputation-based methods will be used to address missing data at follow-ups.

Intervention adherence will be monitored by the number of participants accessing the weekly training modules.

Ethics and dissemination

Ethics approval

The trial will be conducted according to the guidelines laid down in the Declaration of Helsinki, the guidelines of the Ethics Review Panel (ERP) of the University of Luxembourg and the European Union General Data Protection Regulation (GDPR). The study design was approved by the ERP on 26 June 2020 (ERP 20-029 SHER). In case of protocol modifications, prior approval of the University’s Ethics Review Panel will be sought and communicated to all parties concerned (trial participants and trial registries).

The study is registered on ClinicalTrials.gov (NCT04792177); all necessary information according to the WHO recommendations is provided (Table 2).

Table 2 WHO trial registration dataset
Full size table

Dissemination plan

Study findings will be disseminated through peer-reviewed publications, conference presentations, posters, and social media channels. The research findings will provide important information concerning the efficacy of an Internet-based emotion-regulation intervention for sexual health. The outcomes of the study have the potential to establish the evidence-base for an Internet-based emotion-regulation intervention for sexual dysfunctions. The results will also contribute to the identification of the processes involved in the effects of improved emotion regulation skills on depressive and anxiety symptoms, and on sexual self-schema.

Comment

To our knowledge, this will be the first Internet-based emotion regulation intervention to promote sexual health.