Trial document




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  DRKS00010228

Trial Description

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Title

Internet-Based Guided Self-Help for Genito-Pelvic Pain/Penetration Disorder - Randomized Controlled Proof-of-Concept Trial

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Trial Acronym

Paivina-Care Online Health Training

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URL of the Trial

http://www.paivina-care.info/

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Brief Summary in Lay Language

Genito-Pelvic Pain Penetrations Disorder (GPPPD) is a sexual function disorder in women which is characterized by pain and anxiety symptoms associated with vaginal penetration. Difficulties or the impossibility to have vaginal penetration can be a huge impairment of women´s wish to have sexual intercourse and can cause personal and relational burden. It is associated with a wide range of consequences such as low overall sexual functioning, reduced sexual behaviours, and low sexual satisfaction. The „Paivina-Care“ Online-training is designed to meet the needs of women suffering from GPPPD. The program includes modules for psychoeducation, relaxation exercises, cognitive restructuring, body exposition, sensate focus exercises, pain management, gradual exposure via insertion exercises with fingers and dilators and preparation exercises for intercourse with partner. The present study aims to assess the acceptability and effectiveness of a newly developed Internet-based, guided self-help intervention for GPPPD. Participants will be randomly allocated to the intervention or the 6-month waiting control group. Web-based self-report assessments for both groups will be scheduled at baseline, 10 weeks, and 6 months.

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Brief Summary in Scientific Language

Women with Genito-Pelvic Pain/Penetration Disorder suffer from persistent or recurrent difficulties with vaginal penetration or pain during intercourse or intercourse attempts. Marked fear of pain in anticipation of, during, or as a result of vaginal penetration or tensing of the pelvic floor muscles during attempted vaginal penetration characterize the disorder. Difficulties or the impossibility to have vaginal penetration can be a huge impairment of women´s wish to have sexual intercourse and can cause personal and relational burden. Treatment opportunities for GPPPD, however, are scarce.
Using the Internet for delivering guided self-help treatment might be a promising strategy because (1) they are easily accessible at any time and place, (2) anonymity is assured, (3) participants can work at their own pace and review materials as often as they want, and (4) such interventions may reach individuals who otherwise may avoid seeking help.

The present study aims to assess the acceptability and effectiveness of a newly developed Internet-based, guided self-help intervention for GPPPD. In a randomized controlled trial, N=200 women with GPPPD will be randomized to either the 6-month waiting-control or the intervention group.

The program includes modules for psychoeducation, relaxation exercises, cognitive restructuring, body exposition, sensate focus exercises, pain management, gradual exposure via insertion exercises with fingers and dilators and preparation exercises for intercourse with partner. The intervention consists of eight lessons and one booster session four weeks after completion of the training and is based on the online-based guided self-help program “Vaginismus-Free” that has been evaluated in a previous study with N=77 women with vaginismus. Web-based self-report assessments for both groups are scheduled at baseline, 10 weeks and 6 months after randomization. Mediators of treatment efficacy will be assessed after the fifth lesson (about five weeks after randomization). The primary outcome is sexual intercourse.

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Organizational Data

  •   DRKS00010228
  •   2016/05/23
  •   [---]*
  •   yes
  •   Approved
  •   324_15 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F52.5 -  Nonorganic vaginismus
  •   F52.6 -  Nonorganic dyspareunia
  •   DSM-V: Genito-Pelvic Pain/Penetration Disorder
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Interventions/Observational Groups

  •   Intervention group: Online-training consisting of 8 lessons and one booster session four weeks after completing the training. Each session could be completed in approximately 30 to 45 minutes. The program includes modules for psychoeducation, relaxation exercises, cognitive restructuring, body exposition, sensate focus exercises, pain management, gradual exposure via insertion exercises with fingers and dilators and preparation exercises for intercourse with partner. Questionnaires are filled out prior to randomization, during the training (after lesson 5) and after training completion (10 weeks after randomization and 6 month after randomization for follow-up).
  •   Waiting control group: Six months after randomization, participants of the control group will get access to the same training as the intervention group. Questionnaires are filled out prior to randomization and after training completion (10 weeks after randomization and 6 month after randomization for follow-up).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The ability to engage in vaginal penetration (Primary Endpoint Questionnaire, German adaptation, van Lankveld et al., 2006), prior to randomization/start of the training (baseline), during the training (after completion of lesson 5, about 5 weeks after randomization), after training completion (10 weeks and 6 months after randomization).

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Secondary Outcome

• Sociodemographic Questionnaire (pretest)
• Vaginismus Questionnaire (descriptive survey) (pretest)
• Demographic Questionnaire for partner (pretest)
• Female Sexual Function Index, German adaptation (Berner, Kriston, Zahradnik, Härter, & Rohde, 2004) (pretest, peritest, posttest, 6-M-FU)
• Fear of Sexuality Questionnaire, German adaptation (ter Kuile et al., 2007) (pretest, peritest, posttest, 6-M-FU)
• Relationship Questionnaire, short version (Kliam, Job, Kröger, Bodenmann, Richter, Hahlweg, & Brähler, 2012) (pretest, posttest, 6-M-FU)
• Generalized Anxiety Disorder 7-item (GAD-7) scale (GAD-7; Spitzer, Koenke, Williams, & Löwe, 2006) (pretest, posttest, 6-M-FU)
• State Trait Anxiety Inventory (STAI-T; Laux, Glanzmann, Schaffner, & Spielberger, 1981) (pretest, posttest, 6-M-FU)
• Self Esteem Scale (Rosenberg, 1965) (pretest, posttest, 6-M-FU)
• Dyadic Coping Inventory (Bodenmann, 2008, 2010) (pretest, posttest, 6-M-FU)
• Vaginal Penetration Cognition Questionnaire (VPCQ; Klaassen & ter Kuile, 2009) (pretest, peri, posttest, 6-M-FU)
• Well-Being Index (WHO-5; Bech, 2004), psychological well-being/resilience (pretest, posttest, 6-M-FU)
• HAPA Questionnaire (based on Schwarzer et al., 2003): Assessment of motivational and volitional variables referring to the Health Action Process Aprroach (pretest, peritest)
• International Index of Erectile Function for Men (IIEF; Rosen et al., 1997) (pretest)
• Utilization of Additional Help Questionnaire (self development) (posttest, 6-M-FU)
• Client satisfaction in Web-based Interventions Questionnaire (CSWIQ-8; Boß et al, in prep., based on the Client Satisfaction Questionnaire (ZUF-8; Schmidt, Lamprecht &, Wittmann, 1989) and the Client Satisfaction Questionnaire (CSQ; Attkisson & Zwick, 1982))(posttest)
• Reasons for Dropout Questionnaire (self development) (posttest, 6-M-FU)
• Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014) (posttest, 6-M-FU)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2016/05/30
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• No ability to have sexual intercourse at least in the last 6 months due to GPPPD (Primary Endpoint Questionnaire, German adaptation, van Lankveld et al., 2006)
• Age of 18 or older
• Currently in a heterosexual relationship or having a sexual partner (Sociodemographic Questionnaire)
• GPPPD not attributable to a medical condition, diagnosed by a gynaecologist/other specialist (self-report)
• Internet access (Sociodemographic Questionnaire)
• Willing to give informed consent and to fill out questionnaires

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Exclusion Criteria

• Current or past psychotic or dissociative symptoms (Sociodemographic questionnaire)
• Currently present or past post-traumatic stress disorder (SKID screening)
• Present alcohol abuse or dependency (AUDIT ≥ 6)
• Moderate or severe depression (PHQ, Cut-Off ≥ 4)
• Current bipolar disorder (Sociodemographic questionnaire)
• Currently being in psychotherapy for GPPD (Sociodemographic questionnaire)

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Addresses

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    • Lehrstuhl für Klinische Psychologie und Psychotherapie (KliPs)Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
    • Mr.  Dr.  David Daniel  Ebert 
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie (KliPs)Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
    • Ms.  Dipl.-Psych.  Anna-Carlotta  Zarski 
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie (KliPs)Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
    • Ms.  Dipl.-Psych.  Anna-Carlotta  Zarski 
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Lehrstuhl für Klinische Psychologie und Psychotherapie (KliPs)Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
    • Mr.  Dr.  David Daniel  Ebert 
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie (KliPs)Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)
    • Ms.  Dipl.-Psych.  Anna-Carlotta  Zarski 
    • Nägelsbachstr. 25a
    • 91052  Erlangen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.