Primary objective: to evaluate whether the group programme-plus improves pain during intercourse in women with superficial dyspareunia compared to women in a waiting-list control condition.
ID
Source
Brief title
Condition
- Sexual dysfunctions, disturbances and gender identity disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The mean level of pain during penile/vaginal
intercourse in the CBT condition and the WLC condition at 6 months.
Secondary outcome
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 behaviour);
c) relationship factors (partner responses and relationship satisfaction) (Q2),
cost-effectiveness of the intervention (Q3), 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 behaviour
and/or improvement in positive penetration beliefs and sexual function (i.e.
sexual arousal) (Q4).
Background summary
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, 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, no randomized CBT controlled
trial has incorporated the partner in the treatment until now. The current
study will employ a CBT treatment programme of 10 group sessions and 3 couple
sessions targeting the thoughts, emotions, behaviors and couple interactions
associated with the experience of dyspareunia. It is hypothesed that the group
programme-plus is more effective in improving pain during intercourse in women
with superficial dyspareunia compared to women on a waiting-list control
period.
Study objective
Primary objective: to evaluate whether the group programme-plus improves pain
during intercourse in women with superficial dyspareunia compared to women in a
waiting-list control condition.
Study design
Study design: Eligible women and their partners in one of the participating
centres (n=4, in two conuntries) will be randomized to either the CBT group
programme-plus (CBT group -plus) or waiting list control-period group (WLC),
using a block randomization design stratified for each centre. 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.
Intervention
Intervention: The CBT group programme-plus consists of three 1- hr CBT couple
sessions and ten 2-hr CBT group sessions over a period of 6 months. The
manualized treatment comprize, pain- and sexual education, relaxation and
gradual exposure exercises, sensate focus and sexual communication exercises
for the couple. Six to eight women can participate in each group. Two
psychologists will conduct the couple and group sessions.
Study burden and risks
Participating in this study will not cause any (physical) harm for the
participants and the partners. Participants will be asked to fill in
questionnaires 10 times and partners will be asked to fill in questionnaires
four times. This may cause some discomfort because of the time investment they
have to make (for the participants 20 - 60 min; partners: 20 min per
assessment). The participants will undergo a sexual and psychological interview
(screening) and two times a gynecological examination. Apart from the expected
benefits from the intervention compared to waiting list period, there will be
no benefits for the study participants and partners.
Albinusdreef 2 x
2300 RC Leiden 23333 ZA Leiden
NL
Albinusdreef 2 x
2300 RC Leiden 23333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
heterosexual female, aged 18-45 years, having a heterosexual relationship for
at least 3 months, with a diagnosis of superficial dyspareunia with no apparent
ongoing physical cause to the condition (i.e. ongoing infections). The
diagnosis of superficial dyspareunia will be assessed after full sexual history
taking. The criteria for the diagnosis conform to DSM-5; the pain should be
experienced as superficial pain/pain around the vulvar opening, and have lasted
for more than 6 months during at least 80% of the intercourse attempts.
Furthermore, the participants should have the experience of a successful
intercourse, and have attempted intercourse during the last year.
Exclusion criteria
: if reporting to never have had full intercourse at any time in life or the
partner is not willing to participate in the study. Further exclusion criteria
are: 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 or having gone
through child delivery during the last year; not speaking Dutch or Swedish well
enough to participate in assessment and treatment; or receiving concurrent ; or
receiving concurrent psychological therapy or physiotherapy for superficial
dyspareunia or other sexual complaints during CBT or WLC period.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62089.058.17 |