CBT Group Treatment for Women With Dyspareunia

NCT03427255 | Unknown DMC

• 1 other identifier: CBT group program-plus
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 3

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.

Conditions

Dyspareunia

Keywords

superficial dyspareunia; CBT

Outcome Measures

Primary Outcomes (1)

• Mean level of pain during penile/vaginal intercourse (PI)

  Pain intensity is measured on a scale between 0-10

  6 months; 9 months; 12 months

Secondary Outcomes (10)

• Penetration behavior questionnaire (PBQ)

  6 months; 9 months; 12 months

• Genital pain rating questionnaire (GPQ)

  6 months; 9 months; 12 months

• Female Sexual Function Index (FSFI)

  6 months; 9 months; 12 months

• Female Sexual Distress scale (FSDS)

  6 months; 9 months; 12 months

• Global Measure of Sexual Satisfaction Scale (GMSEX)

  6 months; 9 months; 12 months

Other Outcomes (6)

• Patient Health Questionnaire (PHQ-9)

  6 months; 9 months; 12 months

• Generalized Anxiety Disorder-7 (GAD-7)

  6 months; 9 months; 12 months

• International Index of Erectile Dysfunction (IIEF)

  6 months; 9 months; 12 months

Study Arms (2)

CBT group treatment

ACTIVE COMPARATOR

CBT group treatment-plus involving partners: 10 group sessions and 3 couple sessions

Behavioral: CBT group treatment-plus

Waiting list

OTHER

Six months waiting-list control condition.

Behavioral: CBT group treatment-plus; Other: Waiting-list control condition

Interventions

CBT group treatment-plus BEHAVIORAL

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.

CBT group treatment; Waiting list

Waiting-list control condition OTHER

Waiting-list control condition during length of active treatment (6 months).

Waiting list

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• woman
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Leiden University Medical Center: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (3)

Leiden University Medical Center, Department of Gynecology

Leiden, 2300, Netherlands

NOT YET RECRUITING

Maastricht Universiy Medical Center (MUMC)

Maastricht, 6202, Netherlands

NOT YET RECRUITING

Center for Health and Medical Psychology (CHAMP) Örebro University

Örebro, 70182, Sweden

RECRUITING

MeSH Terms

Conditions

Dyspareunia; Color Vision Defects

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ida K Flink, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

• Moniek M ter Kuile, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida K Flink, PhD

CONTACT

+46(0)19313740; ida.flink@oru.se

Linnéa Engman, MS

CONTACT

+46(0)19303168; linnea.engman@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with a waiting list condition

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: February 9, 2018
• Study Start: September 29, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); NL (2)