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A COGNITIVE BEHAVIOURAL GROUP PROGRAMME - PLUS FOR WOMEN WITH DYSPAREUNIA: A RANDOMIZED WAITING LIST CONTROLLED MULTI-CENTER TRAIL OF EFFICACY

A COGNITIVE BEHAVIOURAL GROUP PROGRAMME - PLUS FOR WOMEN WITH DYSPAREUNIA: A RANDOMIZED WAITING LIST CONTROLLED MULTI-CENTER TRAIL OF EFFICACY - CBT for women with dyspareunia: an RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53106
Enrollment
80
Registered
2017-12-18
Start date
2018-09-05
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dyspareunia pain during intercourse PVD

Interventions

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

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)