Clinical trial NCT04792177: Internet-based Emotion Regulation Intervention for Sexual Health
Official title: SHER 2: Internet-delivered Emotion Regulation Skills Training for Sexual Health: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Sexual Dysfunctions, Psychological
Keywords: internet intervention
emotion regulation
sexual health
Lead sponsor: University of Luxembourg
Sponsor class: OTHER
Collaborators: name: Luxembourg National Research Fund (FNR)
name: Linkoeping University
name: University of Lausanne
First posted: 2021-03-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Female Sexual Function Index (FSFI) at 6 months
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
measure: Change in International Index of Erectile Function (IIEF)at 6 months
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
measure: Change in Sexual Quotient (QS) at 6 months
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Secondary outcomes:
measure: Sexual Modes Questionnaire (SMQ) - Automatic Thoughts subscale
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
measure: Sexual Self-Schema Scale (SSSS).
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
measure: General Anxiety Disorder - 7 (GAD-7)
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
measure: the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: baseline, 2 months after baseline (end of intervention), 8 months after baseline (follow-up)
Other outcomes:
Locations:
city: Esch-sur-Alzette
country: Luxembourg
facility: University of Luxembourg
Study officials:
affiliation: Head of Department Department of Behavioural and Cognitive Sciences
name: Claus Vögele, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: