Trial document




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  DRKS00004837

Trial Description

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Title

Evaluation of an internet-based, therapist-assisted self-help approach to overcome vaginismus

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Trial Acronym

[---]*

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URL of the Trial

http://www.vaginismus-free.info

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Brief Summary in Lay Language

Vaginismus describes recurrent or persistent difficulties of the woman to allow vaginal entry of a penis, a finger, and or any other object, despite the woman's expressed wish to to so.

The online-based self-help training Vaginismus-Free aims to teach women with vaginismus strategies, which have proven to be effective in the treatment of vaginismus (i.e. vaginal and pelvic floor training, relaxation techniques).

Participants are randomized to one of two groups. One group (intervention group) immediately receives access to the online training. The other group (control group) receives access after 6 months.

The aim of the study is to evaluate, if an online-based, assisted self-help training can effectively support women in overcoming their vaginismus.

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Brief Summary in Scientific Language

Vaginismus describes recurrent or persistent involuntary spasms of muscles in the vagina, which render sexual intercourse painful or impossible. Previous studies suggest that a stepped care approach to the treatment of vaginismus should begin with self-help concepts, which have proven to be efficacious and cost-effective (van Lankveld, 2009).
This study aims to develop and evaluate an internet-based, therapist-assisted guided self-help approach for women suffering from vaginismus. The medium provides anonymity, lowers inhibitions to seek out treatment and allows for supportive contact with trained personnel.
In this prospective randomized-controlled trial (N=100) we compare the effects of our intervention with a waiting-list control group over a period of 10 weeks and a 3-months follow-up. Primary outcome is the ability to have sexual intercourse. Secondary outcomes include subjective non-coital aspects of sexual functioning, fear of penetration, avoidance behaviour and relationship quality.

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Organizational Data

  •   DRKS00004837
  •   2013/03/20
  •   [---]*
  •   yes
  •   Approved
  •   AZ 2012-47K, Marburg - Ethikkommission des Fachbereichs Psychologie
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Secondary IDs

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Health Condition or Problem studied

  •   F52.5 -  Nonorganic vaginismus
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Interventions/Observational Groups

  •   The intervention group (N = 50, after randomization) receives access to a 10-week internet-based self-help training (Vaginismus-Free; 10 sections and corresponding diary entries, time needed for section about 30 minutes) with assistance (guided self-help) and (optional) supportive SMS. The aim of the training is to overcome vaginismus.
  •   The control group (N = 50) receives no treatment. Following the last measurement date (after 6 months), the group gains access to the online training.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Single blind
  •   assessor, data analyst
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Ability for penetrative intercourse, measured by the Primary Endpoint Questionnaire (PEQ): pre, post (10 weeks), 3 and 12 months follow-Up

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Secondary Outcome

(1) Socio-demographic Data: Pre
(2) Sexual History: Pre
(3) Emotional skills (SEK-27): Pre
(4) Female Sexual Function (FSFI-D): Pre, Post, 3- and 12-months follow-up
(5) Fear of Sexuality (FSQ): Pre, Post, 3- and 12-months follow-up
(6) Dyadic Coping (DCI): Pre, Post, 3- and 12-months follow-up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2013/05/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

(a) fullfill criteria for nonorganic vaginismus in the last six months (b) had no sexual intercourse within the last six months because of the vaginismus (c) within a heterosexual relationship in the last 3 months (d) internet access (e) fluent in German

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Exclusion Criteria

(a) current substance/alcohol addiction (not nicotine-addiction) (b) acute psychotic symptoms (c) posttraumatic stress disorder due to a sexual or physical assault (d) currently in psychotherapy or was in psychotherapy in the last 6 months or is on a waiting-list

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Addresses

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    • Philipps-Universität Marburg Fachbereich Psychologie AG Klinische Psychologie und Psychotherapie
    • Mr.  Dr.  David Daniel  Ebert 
    • Gutenbergstraße 18
    • 35032  Marburg
    • Germany
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    • Philipps-Universität Marburg Fachbereich Psychologie AG Klinische Psychologie und Psychotherapie
    • Mr.  Christian  Rosenau 
    • Gutenbergstraße 18
    • 35032  Marburg
    • Germany
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    • Philipps-Universität Marburg Fachbereich Psychologie Klinische Psychologie und Psychotherapie
    • Mr.  Christian  Rosenau 
    • Gutenbergstraße 18
    • 35032  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Philipps-Universität Marburg Fachbereich Psychologie AG Klinische Psychologie und Psychotherapie
    • Gutenbergstraße 18
    • 35032   Marburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.