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Table 2 WHO trial registration dataset

From: A randomized controlled trial of an Internet-based emotion regulation intervention for sexual health: study protocol

Data category Information
1. Primary registry and trial identifying number ClinicalTrials.gov NCT04792177
2. Date of registration in primary registry 29 January 2021
3. Secondary identifying numbers
4. Source(s) of monetary or material support University of Luxembourg, Luxembourg National Research Fund
5. Primary sponsor University of Luxembourg
6. Secondary sponsor(s) FNR—Luxembourg National Research Fund
7. Contact for public queries Vinicius Jobim Fischer, MSc, University of Luxembourg, Esch-sur-Alzette, Luxembourg; email: vinicius.fischer@uni.lu
8. Contact for scientific queries Vinicius Jobim Fischer, MSc, University of Luxembourg, Esch-sur-Alzette, Luxembourg; email: vinicius.fischer@uni.lu
Gerhard Andersson, PhD, University of Linköping, Linköping, Sweden; email: gerhard.andersson@liu.se
Joël Billieux, PhD, University of Lausanne, Lausanne, Switzerland; email: joel.billieux@unil.ch
Claus Vögele, Dipl. Psych., PhD, University of Luxembourg, Esch-sur-Alzette, Luxembourg; email: claus.voegele@uni.lu
9. Public title Internet-based emotion regulation intervention for sexual health
10. Scientific title Internet-based emotion regulation intervention for sexual health (SHER 2)
11. Health condition(s) or problem(s) studied Sexual health, mental health, emotion regulation
12. Intervention(s) Emotion regulation skills training: The intervention will consist in 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 min to 1 h per week to complete each module.
13. Key inclusion and exclusion criteria Inclusion criteria for participants:
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).
4. In a stable relationship for at least the preceding 3 months.
Exclusion criteria for participants:
1. Medical conditions that can interfere with the outcomes of the intervention, e.g., diabetes, cancer, and cardiovascular problems.
2. Ongoing psychotherapy.
14. Study type Type: interventional
Study design:
- Allocation: randomized.
- Intervention model: parallel assignment.
- Masking: none (open label)
- Primary purpose: treatment
15. Date of first enrolment 10 March 2021
16. Sample size 102
17. Recruitment status Enrolling
18. Primary outcome(s) - Change in Female Sexual Function Index (FSFI) at 6 months (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up)).
- Change in International Index of Erectile Function (IIEF) at 6 months (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up)).
- Change in Sexual Quotient (QS) at 6 months (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up)).
19. Key secondary outcome(s) Change in Sexual Modes Questionnaire (SMQ)—Automatic Thoughts subscale (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up).
Change in Sexual Self-Schema Scale (SSSS) (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up)).
Change in Patient Health Questionnaire-9 (PHQ-9) (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up)).
Change in General Anxiety Disorder—7 (GAD-7) (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up)).
Change in the Difficulties in Emotion Regulation Scale (DERS) (time frame: baseline, 2 months after baseline (end of intervention), and 8 months after baseline (follow-up)).
20. Ethics review Ethical approval has been obtained from the Ethics Review Panel of the University of Luxembourg (ERP 20-029 SHER).
21. Completion date 30.04.2022 (anticipated)
22. Summary results n/a
23. IPD sharing statement Undecided