Sexual Dysfunction Clinical Trial
— SHER2Official title:
SHER 2: Internet-delivered Emotion Regulation Skills Training for Sexual Health: a Randomized Controlled Trial
NCT number | NCT04792177 |
Other study ID # | SHER 20-029 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 5, 2021 |
Est. completion date | July 30, 2022 |
Verified date | November 2022 |
Source | University of Luxembourg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | July 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Luxembourg | University of Luxembourg | Esch-sur-Alzette |
Lead Sponsor | Collaborator |
---|---|
University of Luxembourg | Linkoeping University, Luxembourg National Research Fund (FNR), University of Lausanne |
Luxembourg,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039775 -
Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A | |
Not yet recruiting |
NCT05918770 -
Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
|
N/A | |
Completed |
NCT02096783 -
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
|
N/A | |
Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
Completed |
NCT02837796 -
Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence
|
N/A | |
Completed |
NCT01660152 -
Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
|
N/A | |
Completed |
NCT01434290 -
Radiation Therapy in Treating Patients With Prostate Cancer
|
Phase 2 | |
Active, not recruiting |
NCT00981305 -
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
|
Phase 3 | |
Completed |
NCT04964895 -
Sexual Quality of Patients After Bladder Cancer Cystectomy
|
N/A | |
Enrolling by invitation |
NCT05832268 -
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
|
||
Completed |
NCT04066218 -
Sexual Function Screening in Childhood Cancer Survivors
|
||
Not yet recruiting |
NCT05530681 -
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
|
N/A | |
Recruiting |
NCT05826691 -
Benign Prostate Surgery and QOL and Sexual Function
|
||
Completed |
NCT04560283 -
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period
|
Phase 4 | |
Completed |
NCT03232801 -
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
|
N/A | |
Suspended |
NCT04544735 -
Improving Women's Function After Pelvic Radiation
|
N/A | |
Completed |
NCT05732844 -
Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
|
N/A | |
Recruiting |
NCT05097469 -
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.
|
N/A | |
Withdrawn |
NCT01635543 -
Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas
|
N/A |