DyspareuniaNCT03427255
CBT Group Treatment for Women With Dyspareunia
A study testing CBT group treatment-plus in people with Dyspareunia, run by Örebro University, Sweden at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dyspareunia
- What is being tested?
- CBT group treatment-plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 29 Sep 2017to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Leiden University Medical Center, Department of Gynecology
Leiden, 2300
Moniek Ter Kuile, PhD, +31(0)715263121, M.M.ter_kuile@lumc.nl
- Not yet recruiting
Maastricht Universiy Medical Center (MUMC)
Maastricht, 6202
Reinhilde Melles, MS, reinhilde.melles@mumc.nl
Sweden1 site, 1 recruiting
- Recruiting
Center for Health and Medical Psychology (CHAMP) Örebro University
Örebro, 70182
Ida K Flink, PhD, ida.flink@oru.se
Linnea Engman, MS, linnea.engman@oru.se
About this study
Official title: A Cognitive Behavioral Group Program-plus for Women With Dyspareunia: A Randomized Waiting List Controlled Multi-center Trial of Efficacy
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.
Read the 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
- Being tested
- CBT group treatment-plus, Waiting-list control condition
- Keywords
- superficial dyspareunia; CBT
- Medical subject headings
- Dyspareunia, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT group treatment-plusBehavioural
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.
Waiting-list control conditionOther
Waiting-list control condition during length of active treatment (6 months).
| Study group | Role | What they receive |
|---|---|---|
| CBT group treatment | Active comparator | CBT group treatment-plus involving partners: 10 group sessions and 3 couple sessions Receives: Behavioral: CBT group treatment-plus |
| Waiting list | Other | Six months waiting-list control condition. Receives: Behavioral: CBT group treatment-plus; Other: Waiting-list control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean level of pain during penile/vaginal intercourse (PI)
Pain intensity is measured on a scale between 0-10
Measured: 6 months; 9 months; 12 months
Secondary outcomes (10)
Penetration behavior questionnaire (PBQ)
The PBQ has seven questions inquiring about the woman's experience during the last month with the following aspects of vaginal penetration: full vaginal penetration with the penis of the partner, self-insertion in the vagina of one finger by the woman, self-insertion in the vagina of two fingers by the woman, insertion in the vagina of one finger by the partner, insertion in the vagina of two fingers by the partner, and self-insertion in the vagina of another object (such as a tampon or a dildo) by the woman and by the partner. Answering categories are as follows: (a) not attempted; (b) attempted, but unsuccessful; (c) attempted and sometimes successful; and (d) attempted and always successful. The total of the scale is calculated and ranges between 4-28.
Measured: 6 months; 9 months; 12 months
Genital pain rating questionnaire (GPQ)
Genital pain experienced by touch and penetration of the vagina will be assessed with the 7- item Genital Pain rating Questionnaire (GPQ). Response categories vary from 0 (not at all) to 10 (worst pain imaginable). The questionnaire consist of two sub-scales: the first sub-scale 'pain on touch and finger insertion'' consists of 6 items (pain by touch of the vulva by the patient herself, pain by touch of the vulva by the patient's partner, pain during insertion of one/two own finger(s) into the vagina, and pain during insertion of one/two finger(s) of the patient's partner) into the vagina. The range of the sub-scale is 0-60. The second sub-scale is 1 item related to pain during intercourse (0-10).
Measured: 6 months; 9 months; 12 months
Female Sexual Function Index (FSFI)
Female Sexual functioning will be assessed with the 19-item Female Sexual Function Index (FSFI). It covers six domains of sexual functioning: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction, and sexual pain. The answers are given on a Likert scale ranging from 0 or 1 to 5, depending on item. For the current study, the total FSFI score will be used, excluding the three items on sexual pain, which gives an indication of the sexual functioning during the past four weeks. The total score ranges between 2-30 with higher scores indicating higher sexual function.
Measured: 6 months; 9 months; 12 months
Female Sexual Distress scale (FSDS)
Sexual related personal distress will be assessed with the 12-item Female Sexual Distress scale (FSDS). Questions are answered on a 0-4 Likert scale and the total score ranges from 0-48 with higher scores indicating higher sexual distress.
Measured: 6 months; 9 months; 12 months
Global Measure of Sexual Satisfaction Scale (GMSEX)
Sexual satisfaction will be assessed with the 5-item Global Measure of Sexual Satisfaction Scale (GMSEX). GMSEX consist of five 7-point dimensions of sexual satisfaction ranging from "Good" to "Bad", "Pleasant" to "Unpleasant", "Positive" to "Negative", "Satisfying" to "Unsatisfying", and "Valuable" to "Worthless". Total scores range from 5-35, with higher scores indicating greater sexual satisfaction.
Measured: 6 months; 9 months; 12 months
Vaginal Penetration Cognition Questionnaire (VPCQ)
Positive and negative cognitions and beliefs regarding vaginal penetration will be assessed with the 22-item Vaginal Penetration Cognition Questionnaire (VPCQ). The VPCQ is a 22-item self-report measure using positive and negative statements about vaginal penetration and is answered on a 7-point Likert scale. Possible answers range from "0 = not at all applicable" to "6 = very strongly applicable." The VPCQ consists of 5 subscales: Control Beliefs (4 items), Catastrophic and Pain Beliefs (5 items), Self-Image Beliefs (6 items), Positive Beliefs (5 items), and Genital Incompatibility Beliefs (2 items).
Measured: 6 months; 9 months; 12 months
Painful Intercourse Self-Efficacy Scale (PISES)
Pain self-efficacy beliefs will be assessed using the 20-item Painful Intercourse Self-Efficacy Scale (PISES), it consists of three sub-scales: self-efficacy for controlling pain during intercourse, for sexual function, and for other symptoms. Answers are given on a 10-point scale ranging from (10) very uncertain to (100) very certain.
Measured: 6 months; 9 months; 12 months
CHAMP Sexual Pain Coping Scale (CSPCS)
Avoidance and endurance coping behaviors during penetration will be assessed with the 12-item CHAMP Sexual Pain Coping Scale (CSPCS). This measure consists of three sub-scales: avoidance, endurance and alternative strategies. Respondents rate their agreement of each statement between 1 ("Never true") and 7 ("Always true"). Total scores range from 4-28 on each sub-scale.
Measured: 6 months; 9 months; 12 months
Maudsley Marital Questionnaire (MMQ)
Relationship satisfaction will be assessed with the 10 items of the marital dissatisfaction subscale of the Maudsley Marital Questionnaire MMQ. Possible range 0-80 with higher scores indicating greater dissatisfaction.
Measured: 6 months; 9 months; 12 months
Approach and Avoidance Sexual Goals (AASG)
To assess sexual motives and goals the 15-item Approach and Avoidance Sexual Goals (AASG) measure will be used. Participants can rate the importance of 9 approach and 6 interpersonal goals in influencing their decision to engage in sex on a 7 point scale.
Measured: 6 months; 9 months; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start29 Sep 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with a waiting list condition
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ida K Flink, PhD, Principal investigator, Örebro University, SwedenMoniek M ter Kuile, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427255
- Sponsor's protocol ID
- CBT group program-plus
- Status last verified
- Apr 2022
- First submitted
- 1 Dec 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Behavioral Group Program-plus for Women With Dyspareunia: A Randomized Waiting List Controlled Multi-center Trial of Efficacy
- ClinicalTrials.gov ID
- NCT03427255
- Acronym / sponsor ID
- CBT group program-plus
- Conditions
- Dyspareunia
- Keywords
- superficial dyspareunia; CBT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Maastricht University Medical Center
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with a waiting list condition
| Arm | Type | Receives |
|---|---|---|
| CBT group treatment | Active comparator | Behavioral: CBT group treatment-plusCBT group treatment-plus involving partners: 10 group sessions and 3 couple sessions |
| Waiting list | Other | Behavioral: CBT group treatment-plus, Other: Waiting-list control conditionSix months waiting-list control condition. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT group treatment-plusThe 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. | Behavioural | CBT group treatment, Waiting list |
| Waiting-list control conditionWaiting-list control condition during length of active treatment (6 months). | Other | Waiting list |
Primary outcome
Mean level of pain during penile/vaginal intercourse (PI)
Time frame: 6 months; 9 months; 12 months
Pain intensity is measured on a scale between 0-10
10 secondary outcomes
Penetration behavior questionnaire (PBQ)
Time frame: 6 months; 9 months; 12 months
Genital pain rating questionnaire (GPQ)
Time frame: 6 months; 9 months; 12 months
Female Sexual Function Index (FSFI)
Time frame: 6 months; 9 months; 12 months
Female Sexual Distress scale (FSDS)
Time frame: 6 months; 9 months; 12 months
Global Measure of Sexual Satisfaction Scale (GMSEX)
Time frame: 6 months; 9 months; 12 months
Vaginal Penetration Cognition Questionnaire (VPCQ)
Time frame: 6 months; 9 months; 12 months
Painful Intercourse Self-Efficacy Scale (PISES)
Time frame: 6 months; 9 months; 12 months
CHAMP Sexual Pain Coping Scale (CSPCS)
Time frame: 6 months; 9 months; 12 months
Maudsley Marital Questionnaire (MMQ)
Time frame: 6 months; 9 months; 12 months
Approach and Avoidance Sexual Goals (AASG)
Time frame: 6 months; 9 months; 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ida K Flink, PhD principal investigator
Örebro University, Sweden
Moniek M ter Kuile, PhD principal investigator
Leiden University Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT group treatment-plus in people with Dyspareunia, run by Örebro University, Sweden at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ida K Flink, PhD (+46(0)19313740, ida.flink@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean level of pain during penile/vaginal intercourse (PI) (time frame: 6 months; 9 months; 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.