Table 2 WHO trial registration dataset

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