Clinical trial NCT03427255: CBT Group Treatment for Women With Dyspareunia
Official title: A Cognitive Behavioral Group Program-plus for Women With Dyspareunia: A Randomized Waiting List Controlled Multi-center Trial of Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspareunia
Keywords: superficial dyspareunia; CBT
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Maastricht University Medical Center
First posted: 2018-02-09
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with a waiting list condition
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* woman
* 18-45 years old
* in a heterosexual relationship for at least 3 months
* diagnosis of superficial dyspareunia (in accordance to DSM5) with no apparent ongoing physical cause to the condition (i.e. ongoing infections).
* past experience of a successful intercourse
* attempted intercourse during the last year

Exclusion Criteria:

* reporting to never have had full intercourse at any time in life
* partner not willing to participate in the study
* major affective disorder, psychotic disorder, substance-related disorder or post traumatic-stress disorder related to the genitals (e.g., as a sequel to sexual abuse) according to DSM-5 criteria
* being pregnant
* gone through child delivery during the last year
* not speaking Dutch or Swedish well enough to participate in assessment and treatment
* receiving concurrent psychological therapy or physiotherapy for superficial dyspareunia during CBT or WLC period.

Primary outcomes:
measure: Mean level of pain during penile/vaginal intercourse (PI)
timeFrame: 6 months; 9 months; 12 months
Secondary outcomes:
measure: Penetration behavior questionnaire (PBQ)
timeFrame: 6 months; 9 months; 12 months
measure: Genital pain rating questionnaire (GPQ)
timeFrame: 6 months; 9 months; 12 months
measure: Female Sexual Function Index (FSFI)
timeFrame: 6 months; 9 months; 12 months
measure: Female Sexual Distress scale (FSDS)
timeFrame: 6 months; 9 months; 12 months
measure: Global Measure of Sexual Satisfaction Scale (GMSEX)
timeFrame: 6 months; 9 months; 12 months
measure: Vaginal Penetration Cognition Questionnaire (VPCQ)
timeFrame: 6 months; 9 months; 12 months
measure: Painful Intercourse Self-Efficacy Scale (PISES)
timeFrame: 6 months; 9 months; 12 months
measure: CHAMP Sexual Pain Coping Scale (CSPCS)
timeFrame: 6 months; 9 months; 12 months
measure: Maudsley Marital Questionnaire (MMQ)
timeFrame: 6 months; 9 months; 12 months
measure: Approach and Avoidance Sexual Goals (AASG)
timeFrame: 6 months; 9 months; 12 months
Other outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months; 9 months; 12 months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 6 months; 9 months; 12 months
measure: International Index of Erectile Dysfunction (IIEF)
timeFrame: 6 months; 9 months; 12 months
measure: Male Sexual Distress Scale (MSDS)
timeFrame: 6 months; 9 months; 12 months
measure: Perceived treatment improvement and satisfaction
timeFrame: 6 months; 9 months; 12 months
measure: EuroQual5 (EQ-5D)
timeFrame: 6 months; 9 months; 12 months
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center, Department of Gynecology
city: Maastricht
country: Netherlands
facility: Maastricht Universiy Medical Center (MUMC)
city: Örebro
country: Sweden
facility: Center for Health and Medical Psychology (CHAMP) Örebro University
Study officials:
affiliation: Örebro University, Sweden
name: Ida K Flink, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center
name: Moniek M ter Kuile, PhD
role: PRINCIPAL_INVESTIGATOR
References: