NCT03427255

CBT Group Treatment for Women With Dyspareunia

A Cognitive Behavioral Group Program-plus for Women With Dyspareunia: A Randomized Waiting List Controlled Multi-center Trial of Efficacy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The current study will employ a group CBT treatment program of 10 group sessions and 3 individual couple sessions targeting the thoughts, emotions, behaviors and couple interactions associated with the experience of dyspareunia. Women with superficial dyspareunia and their partners will be randomized to the CBT group program-plus or a waiting list control period at one treatment location in Sweden and two treatment locations in the Netherlands. The waiting-list control period will be comparable to the treatment duration of six months. It is hypothesized that the group program-plus is more effective in improving pain during intercourse in women with superficial dyspareunia compared to women on a waiting-list control period.

Detailed 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) 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.

Conditions

• Dyspareunia

Interventions

Type	Name	Description
BEHAVIORAL	CBT group treatment-plus	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 conduct the couple and group sessions.
OTHER	Waiting-list control condition	Waiting-list control condition during length of active treatment (6 months).

Timeline

• Start date: 2017-09-29
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-02-09
• Last updated: 2022-04-20

Locations

3 sites across 2 countries: Netherlands, Sweden