This project has three objectives:1. DevelopmentThe development objective is to prepare the implementation of this preventive intervention on the onehand by developing and accommodating protocols for sex counselling in the important fields of…
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Questionnaire for the Screening of Sexual Dysfunctions (QSSD), Female Sexual
Functional Index (FSFI), International Index of Erectile Function (IIEF),
Kostenvragenlijst, Credibility/Expectancy Questionnaire (CEQ), Medical Outcomes
Study 36-item Short Form Health Survey (SF-36), Brief Symptom Inventory-18
(BSI-18), Center for Epidemiologic Studies Depression scale (CES-D) en
Self-Esteem and Relationship Questionnaire (SEAR)
Secondary outcome
Demographic- and Biographic information
Background summary
After providing brief sex counselling sessions for two years now, it is time to
confirm its effectiveness with scientific research.
It is expected that this type of treatment can prevent more serious and chronic
problems in the future, as well as sexual aspects as other mental health
aspects. Furthermore it is thought that a part of the current patients with
sexual problems could be treated with a less expensive, low threshold
treatment, like brief sex counselling. The question is if there is a difference
in (cost-)effectiveness of brief sex counselling in comparison with an
intensive sexological treatment and a control group/waitinglist.
Study objective
This project has three objectives:
1. Development
The development objective is to prepare the implementation of this preventive
intervention on the one
hand by developing and accommodating protocols for sex counselling in the
important fields of sexual
health (sexual and relational problems, STI and reproductive health) and on the
other hand to develop a
plan for a training of nurses and public health workers to acquire additional
expertise in sex counselling.
2. Research into the effects on (sexual) health
The aim of the research is to establish the impact on somatic, mental and
sexual health of the new
preventive intervention, sex counselling.
3. Research into the cost-effectiveness
The aim of the economic evaluation is to examine if the new intervention is
preferable in terms of costs,
impact and utilities from a social perspective.
Study design
The kwantitative study phase is a Randomized Controlled Trial (RCT) with
repeated measures (pre- and post intervention), between-group and
within-subjects design. The study stretches over a period of 20 weeks with a
follow-up periode of 6 months. There is an open randomization procedure.
Intervention
Brief sex counselling: the counsellor reviews the participant*s sexual problem
in maximally three 45
minute sessions and aids the participant in managing or resolving the problem,
or refers to more
specialized help.
Intensive sexological treatment: a (NVVS-) certified sexologist who works in a
specialized mental health
care setting has a maximum of 10 contacts with the participant within a
designated time frame.
Waiting list: in this period no help is offered; upon termination of the
waiting period the participant can choose between brief sex counselling or
sexological treatment.
Study burden and risks
The participants have to fill in questionnaires (approximately 220 minutes).
There is a chance that the testperson will be allocated to the waitinglist
period. After this period (26 weeks) they can choose between the two treatment
interventions.
Universiteitssingel 40
6229 ER Maastricht
NL
Universiteitssingel 40
6229 ER Maastricht
NL
Listed location countries
Age
Inclusion criteria
Heterosexual men and women with sexual problems, with or without a partner, between the age of 18 and 25.
Exclusion criteria
Contra-indicators are primary psychiatric problems on ax 1 or 2 of the DSM-IV-RT, the cause of the dysfunction is found in a disease, use of medication or physical defect.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28205.068.09 |