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van CCT (UK)

van CCT (UK)

The (cost)effectiveness of brief, anonymous and costfree sex counselling on (mental) health.

- candidate number6311
- NTR NumberNTR1952
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2009
- Secondary IDs120620025 ZonMw
- Public TitleThe (cost)effectiveness of brief, anonymous and costfree sex counselling on (mental) health.
- Scientific TitleThe efficacy and cost-effectiveness of brief, anonymous and costfree sex counselling to improve (mental) health in youth.
- hypothesisBrief sex counselling will improve (mental) health and will be at least as effective as but less expensive than a longer and more intensive sexological treatment.
- Healt Condition(s) or Problem(s) studiedDepression, Sexual dysfunction
- Inclusion criteriaHeterosexual males and females with sexual problems between the age of 18 and 25.
- Exclusion criteria1. Prominent psychiatric problems (diagnosed on axis-I or II of DSM-IV-TR);
2. Sexual problems caused by organic malfunction;
3. Medication or drug use;
4. Physical disabilities.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-mrt-2012
- Target number of participants450
- Interventions1. Brief sex counselling;
2. Intensive sexological treatment;
3. Waitinglist.
- Primary outcome1. Sexual functioning;
2. Depression and other mental health problems;
3. Costs.
- Secondary outcome1. Self-esteem;
2. Relationship satisfaction.
- Timepoints1. Baseline, end and follouw-up:
A. Sexual functioning (Vragenlijst voor het ignaleren van Seksuele Disfuncties, Female Sexual Functional Index, International Index of Erectile Function);
B. Depression (Center for Epidemiologic Studies depression scale);
C. Mental health problems (Brief-Symptom Inventory, Medical Outcomes Study 36-item Short Form Health Survey);
D. Costs (cost questionnaire);
E. Self-esteem and relationship satisfaction (Self-Esteem and Relationship Questionnaire).
2. Intermediate:
A. Sexual functioning (Female Sexual Funtional Index/International Index of Erectile Funtion);
B. Costs (cost questionnaire).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Jacques Lankveld van
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe capacity to form romantic relationships and the sexual health of adolescents in the Netherlands are compromised by several factors, such as young age of first intercourse and adolescent depression. Several thresholds like costs and trust prevent adolescents to seek help for their sexual problems. To overcome these thresholds, brief sex counselling has been developed. It has been used successively since 2006 within the Rotterdam Public Health Service (GGD Rotterdam-Rijnmond), but there is lack of information about the effectiveness and cost-effectiveness of brief sex counselling. Therefore, in the current study we will evaluate the (cost-) effectiveness of brief sex counselling for sexual problems in adolescents between 18 and 25 years of age.
- Main changes (audit trail)
- RECORD12-aug-2009 - 11-okt-2009

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