Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Dyspareunia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Controlled Trial with a waiting list conditionMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Description

Rationale: Superficial dyspareunia, a frequent form of chronic genital pain, is associated with decreased sexual function for afflicted women, as well as impoverished sexual satisfaction for women and their partners. While recent research has showed that cognitive-behavioral therapy (CBT) interventi...

Rationale: Superficial dyspareunia, a frequent form of chronic genital pain, is associated with decreased sexual function for afflicted women, as well as impoverished sexual satisfaction for women and their partners. While recent research has showed that cognitive-behavioral therapy (CBT) interventions have effects in regards to reducing pain, enhancing sexual function and improving relational aspects, randomized controlled trials are still sparse. Despite recommendations in the literature to include the partner in the CBT treatment targeted at improving pain and sexuality outcomes, there are no published randomized CBT controlled trials incorporating the partner in the treatment. Primary objective: To evaluate whether the group program-plus improves pain during intercourse in women with superficial dyspareunia compared to women in a waiting-list control condition. Secondary Objective(s): are to evaluate a) women (and partners) sexuality (sexual function, distress & satisfaction), b) women's psychological adjustment (negative and positive penetration beliefs, pain/penetration coping behavior); c) relationship factors (partner responses and relationship satisfaction), and whether an improvement in pain during intercourse is moderated by pre-treatment patient characteristics, such as age, sexual functioning, relationship satisfaction, abuse history, and mediated by a) reduction of negative penetration beliefs, avoidance behavior and/or improvement in positive penetration beliefs and sexual function (i.e. sexual arousal). Study design: Eligible women and their partners in one of the participating centers (n=3, in two countries) will be randomized to either the CBT group program-plus or waiting-list control group (WLC), using a block randomization design stratified for each center. The waiting-list period of 6 months is comparable to the period from the start of the active treatment until the post-treatment measurement. After the WLC, the patients from the WLC will receive the active treatment. Data of these participants will be included in the repeated measures analyses to test the temporal stability of treatment gains. Within-subjects repeated measures comparisons will be conducted for data of participants and their partners at pre-treatment, post-treatment, follow-up at 3 months and 6 months following treatment termination. In addition, participants complete monthly questionnaires at home during the first 6 months. Participants in the active treatment group will also complete weekly measures. These extra measurement are necessary for the mediation analyses. The total study duration (including follow-up) for the participants and their partners is 12-18 months. Intervention: The CBT group program-plus consists of 3 1-hr CBT couple sessions and 10 2-hr CBT group sessions over a period of 6 months. The manualized treatment comprise, pain- and sexual education, relaxation and gradual exposure exercises as well as sensate focus and sexual communication exercises for the couple. 6-8 women participate in each group. Two psychologists will conduct the couple and group sessions.

Tracking Information

NCT #
NCT03427255
Collaborators
  • Leiden University Medical Center
  • Maastricht University Medical Center
Investigators
Principal Investigator: Ida K Flink, PhD Örebro University, Sweden Principal Investigator: Moniek M ter Kuile, PhD Leiden University Medical Center