|- candidate number||6041|
|- NTR Number||NTR1889|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jun-2009|
|- Secondary IDs||24345 ABR-nummer|
|- Public Title||The effectiveness of internetbased therapy on female sexual dysfunctioning.|
|- Scientific Title||The effect of cognitive behavioral therapy on female sexual dysfunction:
A research that compares internet-based with face-to-face therapy.|
|- ACRONYM||The effectiveness of internetbased therapy on female sexual dysfunctioning|
|- hypothesis||1. The effect of cognitive behavioral therapy in internettherapy and face-to-face therapy is larger then without therapy on women with a sexual dysfuntion;|
2. The impact of Internet therapy is just as large as the impact of treatment-as-usual (face-to-face Cognitive Behavioral Therapy).
|- Healt Condition(s) or Problem(s) studied||Internet based sextherapy|
|- Inclusion criteria||Heterosexual women with sexual problems, with or without partner, calling for sextherapy on the internet or with a medical referral for sextherapy. The women are at least three months complaining about the sexual dysfunction. It is possible that they already had help for sexual dysfunctioning. Subjects can use a contraceptive pill. |
|- Exclusion criteria||Contra-indicators are primary psychiatric problems on ax 1 or 2 of the DSM-IV-RT, the cause of the dysfuntion is found in a desease, use of medication, fysical defect, pregnancy or severe relationship problems (score > 30 on the relationdyssatisfactionscale of the MMQ). |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2009|
|- planned closingdate||1-jan-2011|
|- Target number of participants||150|
|- Interventions||The test persons become random ate assigned to several groups. The therapy lasts maximum 20 weeks. During the internet- and the face-to-face-treatment, the test person gets a personal coach and de upportunity to talk to this intaker or personal coach by telephone. There exists the possibility extra of calling in aid of a doctor/seksuoloog and fysiotherapist, during the treatment. |
Internet therapy (GROUP 1):
The ppn. to get a cognitive behaviour therapy for sexual problems in the form of onlinetreatment with personal accompaniment.
The instructions and exercises are structured in a protocol. The personal speculator or coach (psychologist/seksuoloog) becomes supervised and has a weekly intervision. A psychiatrist, relation- and psychotherapist, doctor/seksuoloog and fysiotherapeut are involved in the treatment if necessary. The coach give feedback on the exercises and accompany the pp. by means of internet one time in a week and monthly a telephone evaluation. On average the pp has two exercises in a week and one report of approximately a half hour.
The coach and the pp. to remain involved motivation mails. Both get reported, if the treatment passes through not well. At insufficiently pass through the pp become approached telephonically.
The Internet therapy offers the ppn. their own Internet portal, My Anna, in which they have a library with information on sexuality, sexual problems and relation. They receive housework tasks, which are part of behaviour therapy, for example the cognitive behavioral reports and sensate focus tasks. After the report of the exercise by the ppn., the coach gets the possibility of giving feedback. Feedback reads the pp. in My Anna to continue with a new exercise. The treatment has been built from modules. A module consists of three interventions and a telephone evaluation.
After three modules, respectively aimed at the conscience of the complaint, body perception and relation, the pp goes by to a more intensive form of treatment, in which the emphasis is laid on skills.
Face-to-facetherapie (GROUP 2):
The ppn. to get standard face-to-face state-of-the-art cognitive behaviour therapy (Hengeveld & Brewaeys, 2002, Brewaeys, 2003). The treatment exists from maximum ten conversations with the same contents, as the Internet therapy.
Waiting list (GROUP 3):
The waiting list period lasts 12 weeks. After each treatment the participants themselves choose for the Internet therapy or face-to-face-therapie.
|- Primary outcome||Female sexual functioning (FSFI) and sexually related personal distress (FSDS) in women. Is there a better sexual function and less distress after treatment of the female subjects? |
|- Secondary outcome||Coping, psychological complaints and (sexual) relationship satisfaction.|
Is the way of dealing with difficult life events changing during treatment (UCL), are there less psychological problems (BSI) and is there more satisfaction about the partner relationship after treatment (MMQ).
|- Timepoints||1. Baseline (0 weeks);|
2. Process (10 weeks);
3. End (20 weeks);
4. Follow-up (40 weeks).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Eva Broomans|
|- CONTACT for SCIENTIFIC QUERIES|| Eva Broomans|
|- Sponsor/Initiator ||www.annazorg.nl|
(Source(s) of Monetary or Material Support)
|- Brief summary||After two year practizing internet-based, sexual, cognitive behavioral therapy it is time to lay the theoretical foundations for an effective internettherapy. There are good results of internetbased therapy, but there is no research done on internettherapy for sexual dysfuntioning.
When we put internet sextherapy into practice we see a demant for working at problems via internet. The question is: "Do the effects of treatment last after a follow-up period of six months? |
The advances of internettherapy is that the client chooses their own save environment and moments of doing exercises and reports. They have more control over their own proces in this way in comparison with a regular face-to-face therapy.
Second is that in internettherapy the main means of communication is writing instead of talking.
The main question of this study is:
Is there a difference in effectiveness between internettherapy, regular face-to-face treatment and a control-/waiting listgroup without treatment.
|- Main changes (audit trail)|
|- RECORD||30-jun-2009 - 3-jul-2010|