Journal of Consulting and Clinical Psychology © 2013 American Psychological Association

2013, Vol. 81, No. 6, 1127–1136 0022-006X/13/$12.00 DOI: 10.1037/a0034292

Therapist-Aided Exposure for Women With Lifelong Vaginismus:

A Randomized Waiting-List Control Trial of Efficacy

Moniek M. ter Kuile Reinhilde Melles

Leiden University Medical Center Maastricht University Medical Center

H. Ellen de Groot and Jacques J. D. M. van Lankveld

Charlotte C. Tuijnman-Raasveld Open University
Leiden University Medical Center
This article is intended solely for the personal use of the individual user and is not to be disseminated broadly.
This document is copyrighted by the American Psychological Association or one of its allied publishers.

Objective: Vaginismus is commonly described as a persistent difficulty in allowing vaginal entry of a

penis or other “objects” (e.g., tampons, fingers, speculum). Lifelong vaginismus is diagnosed when a
woman has never been able to have intercourse. The aim of this study was to investigate the efficacy of
therapist-aided exposure for lifelong vaginismus. Method: Seventy women and their partners were
randomly allocated to exposure or a waiting-list control period of 3 months. The main outcome measure
(intercourse ability) was assessed daily during 12 weeks. Secondary outcome measures were complaints
about vaginismus, coital pain, coital fear, sexual distress, and sexual functioning. The exposure treatment
consisted of a maximum of three 2-hr sessions during 1 week at a university hospital. Each participant
performed vaginal penetration exercises herself, in the presence of her partner and a female therapist.
Two follow-up sessions were scheduled over a 5-week period. Results: Thirty-one out of 35 (89%; 95%
CI [72%, 96%]) participants reported having had sexual intercourse at posttreatment compared with 4 out
of 35 (11%; 95% CI [4%, 28%]) participants in the control condition. In most of the successfully treated
women (90%), intercourse was possible within the first 2 weeks of treatment. Moreover, treatment
resulted in clinical improvement regarding other symptoms related to vaginismus, coital fear, coital pain,
and sexual distress. No treatment effects were found regarding other aspects of sexual functioning in
women or their partners. Conclusions: This study provides evidence of the efficacy of therapist-aided
exposure therapy for women with lifelong vaginismus.

Keywords: lifelong vaginismus, exposure, sexual dysfunction, women

Vaginismus is defined in the Diagnostic and Statistical Manual
of Mental Disorders, fourth edition, text revision (DSM–IV–TR) as
This article was published Online First September 23, 2013.
Moniek M. ter Kuile, Outpatient Clinic of Psychosomatic Gynecology
and Sexology, Gynecology Department, Leiden University Medical Cen-
ter, Leiden, the Netherlands; Reinhilde Melles, Outpatient Clinic of Sex-
ology, Maastricht University Medical Center, Maastricht, the Netherlands;
H. Ellen de Groot and Charlotte C. Tuijnman-Raasveld, Outpatient Clinic
of Psychosomatic Gynecology and Sexology, Gynecology Department,
Leiden University Medical Center; Jacques J. D. M van Lankveld, Depart-
ment of Psychology, Open Universiteit, Heerlen, the Netherlands.
The study was supported by a grant from the European Society for
Sexual Medicine. We are grateful to Philomeen Weijenborg, Corrie Vliet
Vlieland, Hanneke Bolt, Christine Willekes, and Jacques Maas for con-
ducting the physical examinations and students Annemarie Bouten, Mirjam
de Könnigh, Stephanie Uijleman Anthonijs, Emmy van Holten, Ruth de
Kraker, Anja van ‘t Hoff, Sjoukje Pols, Alicia Kerkhof, Daisy Mombeek,
and Rianne de Kok for helping with the data collection.
Correspondence concerning this article should be addressed to Moniek
M. ter Kuile, Outpatient Clinic for Psychosomatic Gynecology and Sex-
ology (VRSP), Poortgebouw-Zuid, P.O. Box 9600, Leiden University
Medical Center (LUMC), 2300 RC Leiden, the Netherlands. E-mail:
m.m.ter_kuile@lumc.nl
1127
an involuntary contraction of the musculature of the outer third of
the vagina interfering with intercourse, causing distress and inter-
personal difficulty (American Psychiatric Association, 2000). This
definition has received considerable criticism. For example, the
focus on vaginal spasm as the key diagnostic criterion has never
been empirically supported (Reissing, Binik, Khalife, Cohen, &
Amsel, 2004). In response to the lack of empirical support for
the DSM–IV diagnostic criteria and the persistent difficulties in
clearly differentiating vaginismus from dyspareunia, the two sex-
ual pain disorders in the DSM–IV have been merged into a new
DSM–5 disorder called “genito-pelvic pain/penetration disorder”
(American Psychiatric Association, 2013).
Lifelong vaginismus occurs when a woman has never been able to
have intercourse. In acquired vaginismus, a woman loses the ability to
have intercourse after a nonsymptomatic period of time. Acquired
vaginismus can be developed as a consequence of dyspareunia (Bis-
was & Ratnam, 1995). As women with acquired vaginismus are
difficult to distinguish from women with dyspareunia (de Kruiff, ter
Kuile, Weijenborg, & van Lankveld, 2000), we focus in the current
study on women with lifelong vaginismus who have never been able
to experience complete vaginal intercourse.
Research on the etiology of vaginismus is scarce, and no defin-
itive cause has been identified. Conservative and religious atti-
 1128 TER KUILE ET AL.
tudes, lack of sex education, sexual abuse, and relationship factors
have all been reported as potential causal variables; however, none
have been confirmed empirically (e.g., van Lankveld et al., 2010).
Physical explanation for lifelong vaginismus is found very infre-
quently (0%–5%), and can include hymeneal or vaginal abnormal-
ities (de Kruiff et al., 2000; Reissing et al., 2004; ter Kuile, van
Lankveld, Vlieland, Willekes, & Weijenborg, 2005). Many women
diagnosed with vaginismus also experience vulvar pain on touch
(40%–100; Basson, 1996; de Kruiff et al., 2000; Reissing et al.,
2004; ter Kuile et al., 2005). This vulvar pain is typically diag-
nosed as provoked vestibulodynia (Moyal-Barracco & Lynch,
2004), but may also be the result of pelvic-floor muscle tension at
the entrance of the vagina and/or lack of sexual arousal and
This article is intended solely for the personal use of the individual user and is not to be disseminated broadly.
lubrication. Vaginismus is classified as a sexual dysfunction; how-
This document is copyrighted by the American Psychological Association or one of its allied publishers.
ever, little research information is available on sexual function and
response of women with lifelong vaginismus. Whereas some
women and their partners report few sexual problems if vaginal
penetration is not anticipated or attempted, others find their sexual
functioning significantly compromised (e.g., van Lankveld et al.,
2010).
On the basis of the fear-avoidance model of Vlaeyen and Linton
(2000), a fear-avoidance model was proposed for vaginismus
(Reissing, 2009; ter Kuile, Both, & van Lankveld, 2010). This
model provides an explanation of why vaginal penetration prob-
lems develop in some women who experience fear and/or pain
with attempted vaginal penetration. The basic tenet of the model is
that catastrophic thinking about vaginal penetration and/or a cat-
astrophic interpretation of a negative experience with penetration
(e.g., pain, genital incompatibility) elicit vaginal penetration-
related fears. To cope with fear, a woman may avoid all activities
related to vaginal penetration, or she may be hypervigilant for
stimuli that are related to her specific fearful thoughts (e.g., pain,
genital incompatibility). The latter can result in an exaggerated
attention to physical sensations and increased fear that facilitates
the experience of pain during attempted vaginal penetration. These
attempts are met with defensive pelvic muscle contractions. In-
creased muscle tone results in further pain or failed attempts. The
experience of the inability to “achieve” penetration in turn con-
firms negative expectations, thereby further exacerbating and per-
petuating the vicious cycle of vaginismus. Some of the elements of
the cycle have received empirical support (e.g., Klaassen & ter
Kuile, 2009; Reissing et al., 2004; Shafik & El Sibai, 2002; ter
Kuile et al., 2009; van der Velde & Everaerd, 2001; van der Velde,
Laan, & Everaerd, 2001).
The widespread application of the anxiety-reduction approach
of gradual exposure reflects the consensus among theoreticians
and clinicians about the important role of anxiety in vaginismus
(Melnik, Hawton, & McGuire, 2012; Reissing, Binik, & Khalife,
1999). Gradual exposure is nearly always combined with a form of
applied relaxation. These core elements are often included within
the context of a broader approach involving cognitive restructur-
ing, education, sex therapy, and homework assignments (Melnik et
al., 2012; Reissing et al., 1999).
The first randomized controlled trial (RCT) investigated 117
women with lifelong vaginismus assigned to cognitive-behavioral
therapy (CBT) either in group or bibliotherapy format, or to a
wait-list control group (van Lankveld et al., 2006). Group therapy
consisted of ten 2-hr sessions with six to nine participants per
group. Assistance with minimal-contact bibliotherapy consisted of
six biweekly 15-min telephone contacts. Treatment included sex-
ual education, relaxation exercises, gradual exposure, cognitive
therapy, and sensate focus exercises. After receiving 3 months
CBT, either in a group therapy or bibliotherapy format, 18% of the
treated participants had successfully attempted intercourse, com-
pared with none in the wait-list group. CBT did not produce
changes in subjective reports of sexual functioning of participants
or their partners. Successful treatment outcome was partly medi-
ated by a reduction of “fear of coitus” and avoidance behavior (ter
Kuile et al., 2007). Consequently, it was hypothesized that the
effectiveness of treatment might be enhanced by focusing more
explicitly and systematically on exposure to the feared stimuli.
To test this hypothesis, a prolonged, therapist-aided exposure
treatment was developed (ter Kuile et al., 2009). In this treatment,
exposure was self-controlled (patient self-performed vaginal pen-
etration exercises, with, i.e., fingers, dilators), was facilitated by a
female therapist, consisted of a maximum of three 2-hr sessions
within 1 week, and was followed up with exercises at home. Nine
out of 10 participants reported intercourse following treatment,
and, for five of the successful cases, intercourse was possible
within the first week of treatment. Exposure was successful in
decreasing fear and negative penetration beliefs, and treatment
gains were maintained at 1-year follow-up. Most of the partici-
pants needed only one therapist-aided exposure session of 2 hr.
The additional sessions were used to discuss homework and prog-
ress (ter Kuile et al., 2009).
The aim of the current study was to investigate the efficacy of
therapist-aided exposure for lifelong vaginismus in a larger sample
of women, using a randomized, waiting-list controlled design. For
exploratory purposes, we assessed partner sexual functioning. We
hypothesized that exposure increases intercourse ability, as the
primary endpoint, compared with no treatment. We expected a
decrease in symptoms of vaginismus and coital fear (ter Kuile et
al., 2009, 2007), and, based on the results of our earlier studies, we
did not expect any effect on subjective aspects of sexual function-
ing in women or their partners (ter Kuile et al., 2009; van Lankveld
et al., 2006).
Method and Materials
Design
The study design comprised a group comparison between treat-
ment and a waiting-list control condition (WLC). The control
condition included assessments at baseline, 6, and 12 weeks, using
the same intervals as the treatment condition. After the 12-week
assessment, waiting-list participants started with the active treat-
ment. Participants were treated in two research centers in the
Netherlands. Randomization was stratified by site to ensure equal
properties in each treatment arm. Randomization was block-
stratified with varying block sizes. Assessment was performed at
each research center by two research assistants who were not
involved in treatment delivery.
Treatment and Therapists
Therapy at the hospital consisted of a pretreatment information
session and the actual treatment sessions. During the 45-min
pretreatment information session, the fear and avoidance model of
 EXPOSURE THERAPY FOR LIFELONG VAGINISMUS: RCT
vaginal penetration was discussed, taking into account the partic-
ipant’s individual emotions, behaviors, and beliefs. The underlying
mechanism of therapy by exposure was then addressed. The ex-
ercises at the hospital were presented as the start of the exposure,
with the participant (and her partner) learning how to approach the
fearful penetration objects as much as possible, until the woman
felt she could master the situation (i.e., until fear/pain levels
substantially decreased).
The actual exposure therapy consisted of a maximum of three
2-hr sessions within 1 week, in which the participant was exposed
to the feared penetration “objects” (i.e., fingers, dilators). The
purpose of these exposure sessions was to enable the woman to
penetrate herself with an object (including fingers or a dilator) that
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was just a little bit larger than the circumference of the erect penis
This document is copyrighted by the American Psychological Association or one of its allied publishers.
of the partner (10 –14 cm). The exposure at the hospital was
self-controlled (i.e., the participant did the exercises involving
vaginal penetration herself). All the exercises were conducted with
the use of lubricants. The exposure tasks were ordered hierarchi-
cally from low fear to high fear. The participant started with the
exercises sitting in a gynecological examination chair (lithotomy
position). The therapist and the partner were standing/sitting be-
side and/or behind the participant. The three of them followed all
the vaginal penetration exercises through a handheld mirror (held
by the therapist). Each penetration exercise was “verbally” di-
rected by the therapist, for example, the direction of the movement
of the object during penetration; instructions on how to relax or
contract the pelvic floor muscles; advice on holding the object for
a time despite an initial strange or irritating sensation at the
introitus or vaginal entry; and when to use more lubricants. If the
progress halted, the therapist took a step back on the hierarchy
before moving forward again. At these moments, she could also
ask the participant to change position (e.g., from sitting on the
chair to sit on one’s heels or to a standing position) or to change
an object (e.g., from dilator to finger). Thus, the therapist facili-
tated shaping the vaginal penetration behavior in a stepwise way
and tried to maximize success experiences of the participant in
different positions and with different penetration objects within
one session. Positive feedback was given both verbally and non-
verbally to increase self-efficacy. If the participant (and her part-
ner) had clear catastrophic cognitions about what could (or could
not) occur during the penetration exercises, the therapist helped the
participant (and partner) to verbalize these expectations. In these
instances, the exposure exercises could also be used as behavioral
experiments, to test the tenability of these negative cognitions. The
general principles of graded exposure were followed.
After each session, the participant and her partner were given a
number of exposure homework assignments. During the first
week, they were asked to practice with the use of lubricants, two
to three times daily. The therapist took care to convey the message
that these penetration activities should be performed in a “safe”
(harmless) way. The role of the partner was to motivate the
participant to do these exercises and to help her in confronting new
fearful penetration objects. As soon as possible, he was also
actively involved in the home exercises (e.g., by vaginal insertion
of one, two, or, if necessary, three or four fingers of himself;
touching of the vaginal entry with the erect penis without pene-
tration; vaginal insertion of the erect penis; and finally making
bodily movements with the erect penis). All participants received
a treatment manual with homework instructions and with direc-
1129
tions on how to overcome situations if exercises at home failed.
Subsequent exposure sessions always started with a short discus-
sion about the homework assignments and listening to questions
the participant and her partner might have. After that, if still
necessary, the exercises of the former exposure session were
repeated before moving on to the next step in the hierarchy. Three
therapist-aided exposure sessions were scheduled in the first week,
followed by two follow-up sessions over a period of 5 weeks, in
which homework was discussed and questions were answered. In
all cases, the partner accompanied the participant during the full
treatment session. The treatment procedure in the current study
was similar to the procedure used in our previous study (ter Kuile
et al., 2009). The treatment manual is available on request from the
first author.
Therapists
Treatment was conducted by four female psychologists and a
female social worker with 2 years training in sexology. The four
psychologists involved in treatment delivery each had at least 15
years of experience in treating women with vaginismus. Weekly
supervision sessions were held at each center, and once a month a
group supervision session was held with all the therapists to ensure
competence and adherence to the treatment protocol. All treatment
sessions were audiotaped to have a direct check on therapist
adherence and competency.
Participants
Applicants were referred to the outpatient clinics or responded
to newspaper advertisements. Eligibility criteria were as follows:
heterosexual woman, age 18 years or older, with a diagnosis of
lifelong vaginismus, relationship of at least 3 months’ duration, in
good general health as evidenced by medical history taking, and
oral and written informed consent provided. The diagnosis of
lifelong vaginismus was assessed after full sexual history taking.
The lifelong nature of the complaint was judged by the assessor
(master’s student clinical psychology), based on the applicant’s
self-report. Participants were excluded if they had had full sexual
intercourse at any time; received a DSM–IV–TR diagnosis of
affective disorder, psychotic disorder, substance-related disorder,
or posttraumatic stress disorder related to the genitals (e.g., as a
sequel to sexual abuse), using a standardized psychiatric interview,
or did not speak Dutch well enough to participate in assessment
and treatment. The selection procedure of the current study was
comparable with the procedure used in our previous studies (for
more details, see ter Kuile et al., 2009; van Lankveld et al., 2006).
Approval for the study was obtained from the medical ethical
committees of both involved hospitals.
Procedure
Applicants for the study contacted the institute by telephone or
mail. The first screening occurred by telephone; if the participants
fulfilled the main inclusion criteria, written information by mail
was sent. After 1 week, the research assistant contacted the appli-
cant to ask whether she wanted to participate. A pretreatment
assessment with both partners was scheduled at the hospital. After
general instructions on the study procedure were given and the
 1130 TER KUILE ET AL.

informed consent was obtained; the sexual history and a standard-
ized psychiatric interview were taken to check exclusion criteria.
After completion of the self-report questionnaires, all participants
underwent standardized physical examination by a doctor, who
was not involved in treatment delivery. The goals of this exam
were (a) exclusion of physical causes of vaginismus, (b) reassur-
ance of participants who were concerned about physical causes of
their condition, and (c) to investigate vulvar pain. Couples were
then randomly allocated to either active treatment or WLC, per
treatment center. The duration of treatment was 6 weeks.
Follow-up assessments were performed at 6 and 12 weeks after the
start of treatment. After the 12-weeks follow-up assessment, the
participants in the WLC condition began the exposure treatment.
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Secondary outcome measures. The Golombok Rust Inven-
tory of Sexual Satisfaction (GRISS) contains 28 items and covers
the most frequently occurring sexual complaints of heterosexual
persons with a steady partner (Rust & Golombok, 1986). It has
male and female versions. To investigate symptoms of vaginismus,
the female subscale for “vaginismus” was used for this study. To
investigate erectile dysfunction and sexual dissatisfaction in the
male partners, the male subscales for “impotence” and “dissatis-
faction” were used (scoring ranges: 4 –20). Higher scores indicate
greater problems. One item of the male impotence subscale exclu-
sively referred to intercourse and was replaced by the mean of the
other three subscale items. The Female Sexual Function Index
(FSFI) was used to assess pain during intercourse and overall

sexual functioning (Rosen et al., 2000). The FSFI consists of 19

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items covering six domains of sexual functioning: sexual desire,

Sample Size Calculation
On the basis of our earlier studies, it was hypothesized that at
12-weeks assessment, no more than 15% of the participants in the
WLC condition would be classified as responder (can have full
intercourse) compared with at least 60% in the exposure condition.
The effect size of g ⫽ .25 can be considered as large. With a
chosen alpha value of .05, a power of 80%, and an effect size of
g ⫽ .25, a minimum of 26 participants were needed in each group
(Cohen, 1977).
Assessment
Primary outcome measure.
Diary. The participants answered the following question ev-
eryday: “Have you had sexual intercourse with your partner,
including full penile penetration of the vagina?” Possible answers
were on a 3-point scale: (a) I have not attempted to have sexual
intercourse (coded 0), (b) I have attempted to have intercourse,
and have not had full penile penetration of my vagina (coded 0),
and (c) I have attempted to have intercourse, and have had full
penile penetration of my vagina (coded 1). On the basis of these
daily dichotomized answering categories, two scores were derived
(a) a weekly “frequency of sexual intercourse score” and (b) a
dichotomized outcome score over the total measure period for
intercourse (yes/no) (our primary outcome measure).
sexual arousal, lubrication, orgasm, sexual satisfaction, and sexual
pain. For the current study, the sexual pain subscale score and a
total score, excluding the three items on sexual pain, were com-
puted. Higher scores indicate less sexual pain and higher sexual
functioning.
To assess fear of coitus, the three-item “fear of coitus” subscale
of the Fear of Sexuality Questionnaire (FSQ) was used (ter Kuile
et al., 2007). The FSQ inquires about the frequency of a person’s
fear experiences in different sexual situations. For example, “How
often do you experience feelings of fear when you think of inter-
course”? A higher score indicates more fear.
To assess sexuality-related personal distress, the 12-item Fe-
male Sexual Distress scale (FSDS; Derogatis, Rosen, Leiblum,
Burnett, & Heiman, 2002) was used. Higher scores indicate higher
sexual distress. All measures have been used in the other studies
and were validated for a Dutch population (see ter Kuile et al.,
2009; van Lankveld et al., 2006). See Table 1 for the psychometric
properties of the measures used.
Additional assessment. The Sexual and Physical Abuse
Questionnaire is a self-report questionnaire for evaluating the
presence and severity of sexual and physical child abuse experi-
ences (Kooiman, Ouwehand, & ter Kuile, 2002). The included
items are confined to “hands-on” forms of abuse.
Provoked Vestibulodynia (PVD) was assessed using a standard-
ized physical examination for sexual pain disorders, at baseline (de

Table 1
Means and Standard Deviations of Women With Lifelong Vaginismus (n ⫽ 70) and an Age-Matched Control Population of
Unsymptomatic Women (n ⫽ 70)a

Cutoff score for

Vaginismus population Healthy population
Measure Score range M (SD) M (SD) ␣ R RC Improved Recovered

GRISS vaginismus scale 4–20 17.73 (2.51) 4.81 (1.34) .94 .86 2.00 ⬍12.70 ⬍7.49
FSFI pain scale 0–6 0.38 (0.75) 5.61 (1.03) .99 .97 0.36 ⬎1.88 ⬎3.55
Coital fear 0–4 2.16 (1.06) 0.10 (0.29) .91 .73 1.53 ⬍0.68
FSDS sexual distress score 0–48 23.68 (9.34) 4.28 (6.62) .97 .93 5.85 ⬍17.52
FSFI total score 2–31 19.72 (7.06) 25.65 (2.74) .95 .93 3.59 ⬎20.17
Note. Test–retest reliability and cutoff scores for clinical improvement and recovery on the self-report measures. R ⫽ test–retest reliability of this measure within
a Dutch population; RC ⫽ reliable change score; Improved ⫽ Mvaginismus population ⫾ 2 SDvaginismus population; Recovered ⫽ Mhealthy population ⫾
2 SDhealthy population; GRISS ⫽ Golombok Rust Inventory for Sexual Satisfaction; FSFI ⫽ Female Sexual Function Index; FSDS ⫽ Female Sexual Distress Scale.
a
The data from the age-matched control group of unsymptomatic women were specifically selected for the current study and have not yet been published
elsewhere. Except for sexual functioning, the selection procedure and the inclusion and exclusion criteria of the control group were comparable with the
group of women with lifelong vaginismus. Groups did not differ with respect to age, relationship duration, or education level.
 EXPOSURE THERAPY FOR LIFELONG VAGINISMUS: RCT
Kruiff et al., 2000). Vulvar pain was assessed by asking the patient
to indicate the presence of “pain” or “no pain” upon touching the
vestibule with a cotton swab (“touch test”). A maximum of 10 sites
is scored (i.e., Vestibulum 3, 5, 6, 7, 9 o-clock, para-urethral 1; and
11 o-clock, carunculae hymenales, fourchette, and perineal body),
tested clockwise, not at random. For this study, a participant was
rated as having PVD (yes) when she indicated at least on one of the
10 sites “pain” on the touch test.
The Mini International Neuropsychiatric Interview (MINI) is a
semistructured interview for the most common psychiatric disor-
ders according to DSM–IV on Axis I (American Psychiatric As-
sociation., 2000; Lecrubier et al., 1997; Sheehan et al., 1997). The
MINI was used for the assessment of the exclusion criteria (affec-
This article is intended solely for the personal use of the individual user and is not to be disseminated broadly.
tive disorder, psychotic disorder, substance-related disorder, or
This document is copyrighted by the American Psychological Association or one of its allied publishers.
posttraumatic stress disorder related to the genitals).
Statistical analyses. Intent-to-treat analyses were conducted
using data of all enrolled participants (N ⫽ 70). Missing data on
the outcome measures were handled using multiple imputation
chained equations (MICE; Van Buuren, Brand, Groothuis-
Oudshoorn, & Rubin, 2006). The MICE procedure uses linear
regression to estimate the missing values on continuous variables,
using the other variables as predictors, and logistic regression to
estimate the missing values on categorical variables. Van Buuren,
Boshuizen, and Knook (1999) recommend using a maximum of 25
variables in the imputation model. Besides treatment condition and
research location, the data of the six outcome measures at the three
measures moments were used as predictors in the imputation
model. On the basis of recommendations by Graham (Graham,
2009; Graham, Olchowski, & Gilreath, 2007), data were imputed
five times, which is a conservative choice, as only a maximum of
10% of our data were missing (Van Buuren et al., 1999). The
results of the five imputed databases were combined using Rubin’s
(1987) rules for multiple imputation. SPSS 20.0 automatically
combines the results of multiply-imputed data sets into one pooled
analysis.
To investigate differences in the main outcome measure (inter-
course ability) at 6 weeks and 12 weeks, cross-tabulation and
chi-square tests were used. To investigate baseline to 6 weeks and
12 weeks, changes in secondary outcome measures in participants
and their partners separate 2 Group (exposure, WLC) ⫻ Time 3
(baseline, 6 weeks, and 12 weeks) repeated measures analyses of
variance (ANOVAs) were applied, with the outcome measures
being within-subject factors. To control for possible differences
between the two research centers, treatment location was added as
a fixed factor in all the ANOVAs.
For ANOVAs, the ␩p2 effect sizes are reported. For the pur-
pose of interpretation, Cohen considers .010 ⬍ ␩2 ⬍ 0.09 as
small, and 0.09 ⬍ ␩2 ⬍ 0.25 as medium, and ␩2 ⬎ 0.25 as large
effect (Cohen, 1977). The clinical significance of observed
changes between baseline, 6-, and 12-weeks assessment on
secondary outcome measures was examined using the criteria of
Jacobson and Truax (1991). Change magnitude was determined
by calculating the reliable change index for scores between
baseline, 6 weeks, and 12 weeks. Cutoff scores for clinical
improvement and recovery on the self-report measures are
summarized in Table 1. The SPSS, version 20.0 for Windows,
was used for all analyses.
1131
Results
Demographic Data and Treatment-Related
Information
Over a period of 18 months, 72 couples were assessed at the
hospital for eligibility. Two couples were excluded (depression, vag-
inal septum), and 70 couples were enrolled. Figure 1 shows the
participant flow. Table 2 presents demographic data. Participants’
mean age was 28.9 (⫾ 7.3) years, and their partners’ was 30.8 (⫾7.8).
Four participants had children and had become pregnant by self-
insemination with the semen of their own partners. Because they
remained unable to have intercourse after childbirth, these participants
were included in the study. Twenty-nine participants (41%) reported
they wanted to become pregnant by intercourse within the year after
onset of therapy. Using a standard physical examination (cotton swab
test; de Kruiff et al., 2000), about half the participants (51%) met the
criteria for PVD (Moyal-Barracco & Lynch, 2004). The sexual abuse
history rate (29%) was not different from the general Dutch popula-
tion (Draijer, 1990). Participants’ demographic characteristics at the
two research centers revealed some differences (see Table 2). After
randomization, however, the two treatment groups did not differ on
demographic and treatment history.
No baseline group differences were found regarding complaints
about vaginismus (GRISS), pain (FSFI), fear of coitus (FSQ), and
sexual functioning (FSFI). Control group participants reported
significantly (p ⬍ .05) higher baseline sexual distress scores
(FSDS) than participants in the treatment condition (see Table 3).
Male partners did not show baseline group differences for erectile
dysfunction and sexual dissatisfaction (GRISS).
Dropouts
In total, seven participants (10%) left the study before the
12-weeks assessment (see Figure 1). Three of the four couples who
dropped out in the treatment condition dropped out because the
relationship ended (one before treatment and two after treatment)
(see Figure 1). T tests for independent samples revealed no differ-
ences between dropouts and follow-through participants (p ⬍ .05)
on demographic or pretreatment sexual functioning data.
Posttreatment Data
Daily ratings for intercourse attempts at 6-weeks and 12-
weeks assessment. Treated participants more often reported suc-
cessful intercourse at 6-weeks assessment than waiting-list partici-
pants, ␹2(1, 70) ⫽ 51.94, p ⬍ .001 (see Table 3). In the exposure
condition, 31 out of 35 (88.6%; 95% CI [72.3%, 96.3%]) participants
reported having had intercourse, compared with none of the control
participants. Of the participants who reported having had intercourse
at the 6-weeks assessment, all reported having had intercourse within
the first 4 weeks of treatment, and 28 participants reported coitus
during the first 2 weeks (90%). The median of the weekly intercourse
frequency was 1.77 (range ⫽ 0 –5.5) in the exposure condition, during
Weeks 1 and 6. These treatment effects were maintained in the period
between 7 and 12 weeks after treatment termination, ␹2 (1, 70) ⫽
31.54, p ⬍ .001 (see Table 3). In the exposure condition, 29 out of 35
(82.9%) participants reported having had intercourse during this pe-
riod (median of weekly frequency ⫽ 1.05; range ⫽ 0 –5.5), compared
 1132
Assessed for eligibility (n = 72)
Randomized (N = 70)
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Assigned to exposure (n =35)
Exposure treatment (n=34)
Did not receive exposure (n = 1)
Reason: relationship ended
Discontinued participation during treatment (n = 1)
Reason: relationship ended
6 weeks assessment (n =31)
Missing data (n=2)
Discontinued participation during follow-up period (n = 2)
Reason: relationship ended (n = 1) / Other problems (i.e. burn-
out) (n= 1)
12 weeks assessment (n =31)
Figure 1. Flow of participants through each stage of the study. WLC ⫽ waiting-list control condition.
with four out of 35 control participants (11.4%; 95% CI [3.7%,
27.7%]; median weekly frequency ⫽ 0; range ⫽ 0 –3.1). The six
couples who did not report intercourse during Weeks 7 and 12
included the same four couples who did not report intercourse during
Weeks 1 and 6. No main or interaction effects of research location
were found.
Secondary outcome measures at 6 and 12 weeks. On the
GRISS vaginismus scale, there were significant main effects for
time, F(2, 132) ⫽ 80.59, p ⬍ .001, ␩p2 ⫽ 0.55, and condition, F(1,
65) ⫽ 52.52, p ⬍ .001, ␩p2 ⫽ 0.41, and a Time ⫻ Condition
interaction, F(2, 132) ⫽ 45.04, p ⬍ .001, ␩p2 ⫽ 0.40, was found.
Post hoc analyses indicated that participants in the exposure con-
dition reported significantly fewer symptoms related to vaginismus
than control participants at 6 weeks and 12 weeks. Thirty partic-
ipants (86%) in the exposure condition and eight (23%) control
TER KUILE ET AL.
Excluded (n = 2)
exclusion criteria: depression (n = 1), somatic
reason complaint (vaginal septum) ( n= 1)
Enrolled (N=70)
Assigned to Waiting List (WLC) (n = 35)
Discontinued participation during WL
period (n = 1)
6 weeks assessment (n =34)
Discontinued participation during follow-up
period (n = 2)
Reason: pregnant (n = 1)/Unknown (n = 1)
12 weeks assessment (n =32)
group participants improved at 12 weeks. Sixteen (46%) of these
participants in the exposure condition completely recovered (Ja-
cobson & Truax, 1991), compared with 0% in the WLC condition
at 12 weeks (see Table 3).
On the FSFI pain scale, there were significant main effects for
time, F(2, 132) ⫽ 45.19, p ⬍ .001, ␩p2 ⫽ 0.41, and condition, F(1,
65) ⫽ 23.07, p ⬍ .001, ␩p2 ⫽ 0.26, and a Time ⫻ Condition
interaction, F(2, 132) ⫽ 26.46, p ⬍ .001, ␩p2 ⫽ 0.29, was found.
Post hoc analyses indicated that participants in the exposure con-
dition reported significantly less pain than control participants at 6
weeks and 12 weeks. Twenty-three (69%) participants in the
exposure condition and seven (13%) control group participants
improved at 12 weeks. Nineteen (54%) of these participants in the
exposure condition completely recovered, compared with three
(9%) in the WLC condition at 12 weeks (see Table 3).
 EXPOSURE THERAPY FOR LIFELONG VAGINISMUS: RCT 1133

Table 2
Demographic and Treatment History Characteristics of Women With Lifelong Vaginismus

Study group Location Total

Exposure Waiting list
Variable (n ⫽ 35) (n ⫽ 35) X (n ⫽ 50) Y (n ⫽ 20) (N ⫽ 70)

Age woman (y) M (⫾SD) 28.54 (7.83) 29.29 (6.92) 29.74 (7.70) 26.85 (6.07) 28.91 (7.34)
Age partner (y) M (⫾SD) 30.91 (8.15) 30.69 (7.56) 31.56 (7.92) 28.90 (7.17) 30.80 (7.76)
Duration relationship (y) M (⫾SD) 6.82 (6.46) 5.51 (4.64) 6.65 (5.83) 5.01 (5.07) 6.18 (5.63)
Duration complaint (y) M (⫾SD) 9.61 (6.36) 11.21 (6.71) 10.79 (6.84) 9.48 (5.78) 10.41 (6.54)
n (%) n (%) n (%) n (%) N (%)
Recruitment/referral (%)
Self-referred 24 (69) 22 (63) 36 (72) 10 (50) 46 (66)
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Family doctor 1 (3) 2 (6) 2 (4) 1 (5) 3 (4)

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Gynecologist 3 (9) 2 (6) 3 (6) 2 (10) 5 (7)

Other 7 (20) 9 (26) 9 (18) 7 (35) 16 (23)
Previous treatment from
Any professional 26 (74) 27 (77) 36 (72) 17 (85) 53 (76)
Psychologists 7 (20) 10 (29) 13 (26) 4 (20) 17 (24)
Sexologists 21 (60) 18 (51) 28 (56) 11 (55) 39 (56)
Physical therapists 11 (31) 12 (34) 15 (30) 8 (40) 23 (33)
Medical doctors 9 (26) 13 (37) 14 (28) 8 (40) 22 (31)
Other professionals 6 (17) 8 (23) 9 (18) 5 (25) 14 (20)
Alternative healers 2 (6) 3 (9) 4 (8) 1 (5) 5 (7)
Education
Secondary school 13 (37) 11 (31) 18 (36) 6 (30) 24 (34)
Higher secondary school 6 (17) 5 (14) 7 (14) 4 (20) 11 (16)
College–university 16 (46) 19 (55) 25 (50) 10 (50) 35 (50)
Religion
None 10 (29) 11 (32) 17 (35) 4 (21) 21 (31)
Catholic 14 (40) 11 (32) 13 (27) 11 (58)ⴱ 24 (35)
Protestant 9 (26) 8 (24) 15 (31) 2 (11) 17 (25)
Islam 2 (6) 4 (12) 4 (8) 2 (10) 6 (9)
Lives with partner (% yes) 27 (77) 27 (77) 42 (84) 12 (60)ⴱ 54 (77)
Has a child (% yes) 1 (3) 3 (9) 3 (6) 1 (5) 4 (6)
Desire to become pregnant 13 (37) 16 (46) 24 (48) 5 (25) 29 (41)
PVD (% yes) 16 (46) 20 (57) 21 (42) 15 (75)ⴱ 36 (51)
Sexual and physical abuse (% yes) 13 (37) 10 (29) 16 (32) 7 (35) 23 (33)
Any sexual abuse 11 (31) 9 (26) 13 (26) 7 (35) 20 (29)
Genitals touched 8 (23) 3 (9) 10 (20) 6 (30) 16 (23)
Coerced into sexual acts 8 (23) 3 (9) 8 (16) 3 (15) 11 (16)
Coerced into intercourse 4 (12) 1 (3) 4 (8) 3 (15) 7 (10)
Physical assault 4 (12) 5 (10) 0 (0) 5 (7)
Note. y ⫽ years; PVD ⫽ Provoked Vestibulodynia.
ⴱ
p ⬍ .05.

On the fear of coitus scale, there were significant main effects
for time, F(2, 132) ⫽ 32.14, p ⬍ .001, ␩p2 ⫽ 0.32, and condition,
F(1, 65) ⫽ 7.33, p ⬍ .01, ␩p2 ⫽ 0.10, and a Time ⫻ Condition
interaction, F(2, 132) ⫽ 7.23, p ⬍ .01, ␩p2 ⫽ 0.10, was found. Post
hoc analyses indicated that participants in the exposure condition
reported significantly less fear of coitus than control participants at
6 weeks and 12 weeks. Eighteen (51%) of these participants in the
exposure condition completely recovered, compared with seven
(20%) in the WLC condtion at 12 weeks (see Table 3).
As significant differences were found between both conditions
on the FSDS baseline scores, analyses of covariance were con-
ducted, while controlling for baseline levels. On the FSDS, a
significant main effect of condition, F(1, 66) ⫽ 7.00 p ⬍ .05, ␩p2 ⫽
0.10, was found. Post hoc analyses indicated that participants in
the exposure condition reported significantly lower sexual distress
than the participants in the control condition at 6 weeks and 12
weeks. No statistical differences were observed for sexual function
(FSFI-total score; see Table 3).
Partners
Repeated measures ANOVAs, with condition and treatment
location as between-subject factors, revealed no main or interac-
tion effects of treatment for sexual dissatisfaction or erectile dys-
function (GRISS).
Treatment
The mean number of exposure therapy sessions was 1.88 ⫾
0.77 (M ⫹ SD; range ⫽ one to four sessions), and the total
amount of time spent during exposure was 151 min ⫾ 81 (M ⫹
SD; range ⫽ 50 – 405 min) in the 34 couples who received
exposure treatment.
Discussion
This is the first study in which the efficacy of therapist-aided
exposure for lifelong vaginismus was investigated in a randomized
 1134 TER KUILE ET AL.

Table 3
Intent-to-Treat Effects of Therapist-Aided Exposure Treatment of Women With Lifelong Vaginismus and Their Partners on Self-Report
Measures of Successful Coitus Attempts, Symptoms of Vaginismus, Sexual Functioning, and Sexual Distress

Participants who improved (I) and/or

recovered (R)
Baseline 6 weeks 12 weeks
Variable M (SD) M (SD) M (SD) 6 weeks n (%) 12 weeks n (%)

Participants
Coitus n (%) (diary)
WLC 0/35 (0%) 0/35 (0%) 4/35 (11.4%)
Exposure 0/35 (0%) 31/35 (88.6%) 29/35 (82.9%)
GRISS vaginismus
WLC 17.83 (2.50) 17.06 (2.95) 16.21 (4.03) 3 (9%) I / 0 (0%) R 8 (23%) I / 0 (0%) R
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Exposure 17.63 (2.56) 9.10 (4.08) 8.96 (3.68) 13 (37%) I / 16 (46%) R 14 (40%) I / 16 (46%) R
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FSFI pain
WLC 0.46 (0.86) 0.67 (1.18) 1.04 (1.45) 4 (11%) I / 1 (0%) R 5 (14%) / 3 (9%) R
Exposure 0.25 (0.64) 3.34 (1.80) 3.09 (2.08) 9 (26%) I / 19 (54%) R 5 (14%) I / 19 (54%) R
Fear of coitus
WLC 3.23 (1.01) 3.01 (1.12) 2.76 (1.00) 6 (17%) R 7 (20%) R
Exposure 3.10 (1.11) 2.20 (0.92) 1.98 (0.92) 13 (37%) R 18 (51%) R
FSFI total
WLC 19.26 (6.70) 18.32 (7.71) 18.64 (8.48)
Exposure 20.12 (7.51) 19.85 (7.38) 20.55 (7.36)
FSDS sexual distress
WLC 26.26 (9.58) 24.53 (11.12) 23.13 (12.09) 7 (20%) R 12 (34%) R
Exposure 21.11 (8.46) 14.87 (11.10) 14.76 (11.25) 20 (57%) R 23 (66%) R
Partners
Male GRISS erectile dysfunction
WLC 6.55 (2.73) 6.81 (2.57) 6.90 (2.93)
Exposure 6.21 (2.38) 6.32 (2.54) 6.12 (2.57)
Male GRISS dissatisfaction
WLC 9.75 (3.25) 9.67 (3.48) 9.75 (3.41)
Exposure 9.62 (3.50) 9.47 (3.37) 9.24(3.43)
Note. Number of intent-to-treat participants: Total N ⫽ 70. Comparison shown is of baseline, 6 weeks’, and 12 weeks’ data of therapist-aided exposure (exposure)
and waiting-list control condition (WLC). I ⫽ Improved ⫽ Mvaginismus population ⫾ 2 SDvaginimus population; R ⫽ Recovered ⫽ Mhealthy population ⫾
2 SDhealthy population; GRISS ⫽ Golombok Rust Inventory for Sexual Satisfaction; FSFI ⫽ Female Sexual Function Index; FSDS ⫽ Female Sexual Distress
Scale.

trial, using a WLC group. After exposure treatment, 89% of the
treated participants reported having intercourse, and this gain
remained at 3-months follow-up. The main conclusion to be drawn
from the current study is that therapist-aided exposure appears to
be an efficacious therapy for women with lifelong vaginismus.
Moreover, exposure treatment produced clinically relevant re-
ductions in coital fear and sexual distress and a pronounced re-
duction in complaints of vaginismus of a large percentage of the
treated women. As the average duration of complaints of vaginis-
mus in this sample was 10 years, and 76% of the participants had
unsuccessfully sought professional help before, this very quick and
substantial treatment response was remarkable. Although nearly
90% reported having had intercourse, we recognize that for about
half the participants, the GRISS scores for vaginismus and the
FSFI scores for pain were still not within the healthy range of
sexually well-functioning women, indicating that these partici-
pants still reported some discomfort or pain during intercourse. So
there is ample room for improvement. Further research is neces-
sary to investigate whether these participants just need more time
to improve (Bergeron, Khalife, Glazer, & Binik, 2008). However,
it is also possible that this partial improvement in discomfort and
pain will result in higher levels of discomfort, fear, and avoidance
behavior in the long run.
In contrast to the significant and clinically relevant changes on
the vaginal penetration-related measures, treatment did not result
in clinical changes with respect to other aspects of sexual func-
tioning with the partner. This finding was predicted and can be
explained by the exclusive focus of treatment on the behavioral
and emotional changes needed to enable vaginal penetration. In-
terventions aiming to improve sexual functioning, such as enhanc-
ing sexual desire, arousal, lubrication, or orgasm, were not in-
cluded in the present therapy. Furthermore, more than 60% of the
participants did not report other sexual complaints at baseline,
rendering the monitoring of clinical improvement with respect to
sexual functioning impossible for these participants.
We may conclude that focusing treatment on fear and avoidance
behavior resulted in successful intercourse for nearly all the
women with lifelong vaginismus. However, changes in intercourse
behavior after exposure therapy did not directly result in pleasur-
able intercourse for all women or in changes in overall sexual
functioning in both partners. Consequently, if sexual functioning
or sexual satisfaction is problematic, even after the ability to have
intercourse has been achieved, a treatment package specifically
focusing on sexual pleasure and arousal during sexual activity
(including intercourse) may be beneficial for some of the couples.
Future research is needed to investigate whether an additional
 EXPOSURE THERAPY FOR LIFELONG VAGINISMUS: RCT
treatment package is helpful to improve overall sexual functioning
and pleasure, if deemed desirable.
The 89% success rate of exposure treatment that was found in
the current study is similar to the 90% success rate that was
reported in the first 10 women who were treated in this way (ter
Kuile et al., 2009), and is much larger than the 18% success rate
of gradual exposure treatment that was found in our previous RCT
on CBT for lifelong vaginismus (van Lankveld et al., 2006). The
success rate of the current study is comparable with effects re-
ported in earlier, uncontrolled, and controlled outcome studies,
mostly using gradual exposure as one of the main treatment
ingredients (for an overview, see McGuire & Hawton, 2001;
Melnik et al., 2012). As the treatment locations, the characteristics
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of the patients and the therapists, and the measures used in this
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study were all comparable with those in our previous CBT study
(van Lankveld et al., 2006), it can be concluded that focusing more
explicitly and systematically on exposure to stimuli that are feared
during penetration attempts enhanced the effectiveness of treat-
ment for vaginismus dramatically.
The mean number of therapist-aided exposure sessions needed
was less than two, and the remainder of the sessions was used to
discuss homework assignments and progress. The mean total du-
ration of exposure was 2.5 hr. As most of the participants needed
only one exposure session at the hospital, it can be concluded that
therapist-aided exposure therapy is generally brief. However, we
have to keep in mind that the therapists in the current study were
highly experienced in the treatment of lifelong vaginismus.
What can be said about possible mediating mechanisms under-
lying the effects of treatment? According to the fear-avoidance
model of vaginismus, the penetration-related fears in women with
vaginismus are maintained because avoidance prevents disconfir-
mation of the catastrophic beliefs. By directly reducing avoidance
and increasing successful penetration behaviors, fearful penetra-
tion cognitions have to be disconfirmed. As we found large reduc-
tion in coital fear and avoidance behavior, it is conceivable that
exposure also helped to disconfirm these erroneous beliefs. As we
only assessed penetration behavior on a daily basis in contrast to
fear of coitus, the current study is unable to inform on whether
success is mediated by reduction in coital fear. More definitive
conclusions on the mechanisms of change await further study.
Some limitations occurred with this study. First, although we
did audiotape the treatment sessions, to enable a direct check on
therapist adherence and competency, it was not possible to perform
this check, as about 70% of the digital audiodata were inadver-
tently stored as encrypted files (blocked with an unbreakable
code). Consequently, we could not listen to these audiodata. Sec-
ond, we did not compare therapist-aided exposure with other
interventions such as CBT directly. Replication studies with other
therapists and by independent study groups are necessary before
our results can confidently be generalized to daily clinical practice.
In this study, we focused on women with lifelong vaginismus who
have never been able to experience complete vaginal intercourse.
It is currently unclear to what degree women without a partner or
women with acquired vaginismus could benefit from a therapist-
aided exposure therapy and how the treatment protocol would need
to be adjusted to accommodate these patients.
The combination of vaginismus and dyspareunia into genito-
pelvic pain/penetration disorder in the DSM–5 (American Psychi-
atry Association, 2013) is empirically based and in line with the
1135
available research on the overlap of and/or continuity on various
symptom dimensions between the two penetration-related prob-
lems. Also in the current study, we found that about half the
participants reported comorbid pain during intercourse after inter-
course was achieved. Thus, in the treatment of lifelong vaginis-
mus, it is very important to also investigate discomfort and pain in
the sexual situation. However, in view of the relative neglect of
lifelong vaginismus in the empirical literature thus far, it can be
argued that not enough information is available to conclude that
both problems indeed reflect the same disorder. Combining vag-
inismus and dyspareunia into a single disorder, at this point, carries
the risk of extinguishing the recently nascent empirical research
interest in lifelong vaginismus, which may— or may not— dem-
onstrate lifelong vaginismus as a distinct clinical condition requir-
ing differential treatment recommendations (ter Kuile & Reissing,
in press).
In conclusion, this study provides evidence of the efficacy of
therapist-aided exposure therapy for women with lifelong vaginis-
mus. Therapist-aided exposure successfully increased the ability of
women to have intercourse and decreased the amount of symptoms
related to vaginismus, the level of coital fear and distress related to
sexual functioning.
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Received October 11, 2012
Revision received July 10, 2013
Accepted July 29, 2013 䡲