Efficacy of Internet-based Cognitive Behavioral Therapy for Endometriosis
- Conditions
- Endometriosis
- Registration Number
- NCT05098444
- Lead Sponsor
- Philipps University Marburg Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - People with female-assigned reproductive systems aged 18 to 45 years<br><br> - Medically confirmed endometriosis diagnosis<br><br> - Impairment of quality of life due to endometriosis defined as a value of = 15 points<br> across all scales in the Endometriosis Health Profile 30 + 23 (EHP-30 + 23, (Jones,<br> Kennedy, Barnard, Wong & Jenkinson, 2001a)<br><br> - Adequate German language skills<br><br> - Access to a personal computer (PC) / laptop and adequate internet connection<br><br>Exclusion Criteria:<br><br> - Serious mental disorder: unipolar severe depression (Beck Depression Inventory II:<br> raw value = 29), presuicidal syndrome, bipolar affective disorder, unipolar mania,<br> psychotic disorder, alcohol or substance dependence<br><br> - Psychotherapeutic treatment: currently or within the last two years<br><br> - Use of benzodiazepines (prevents learning processes that are important for<br> psychotherapy)<br><br> - Changes in the intake or use (e.g. start / change of dose / discontinuation) of<br> antidepressants and hormonal contraceptives within the last three months<br><br> - Current or planned intrauterine insemination (IUI), in-vitro-fertilisation (IVF) or<br> intracytoplasmic sperm injection (ICSI) treatment with hormonal stimulation within<br> the next eight months<br><br> - Suffering from one of the following diseases: malignant tumor, in particular breast,<br> cervical or ovarian cancer, ulcerative colitis, Crohn's disease, a known bacterial<br> or viral infection (e.g. tuberculosis (TBC), hepatitis A virus (HAV), hepatitis B<br> virus (HBV), hepatitis C virus (HCV)<br><br> - Current pregnancy or birth of a child within the last six months, breastfeeding<br> within the last six months
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Endometriosis Health Profile 30 + 23 (EHP-30 + 23; Jones, Kennedy, Barnard, Wong & Jenkinson, 2001);Change in Endometriosis Health Profile 5 (EHP-5; Jones, Jenkinson & Kennedy, 2004);Change in Pain Disability Index (PDI; Tait, Pollard & Margolis, 1987);Change in Visual analog pain scale (VAS)
- Secondary Outcome Measures
Name Time Method Change in Brief Patient Health Questionnaire (PHQ-9; Zipfel, Herzog & Löwe, 2004);Change in Perceived Stress Scale (PSS; Klein et al., 2016);Change in Brief Cope (Carver, 1997);Change in Illness Perception Questionnaire (IPQ-R; Glattacker, Bengel & Jäckel, 2009);Change in The Acceptance and Action Questionnaire - II (FAH-II; Hoyer & Gloster, 2013)