Clinical trial NCT05098444: Efficacy of Internet-based Cognitive Behavioral Therapy for Endometriosis
Official title: Endometriosis - Internet-based Therapy (Ed.iTh): Evaluation of an Internet-based Cognitive Behavioral Treatment to Improve the Quality of Life With Endometriosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Behavioral medicine
Internet based therapy
Cognitive behavioral therapy
Women's Health
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Wait list control group
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of an internet-based cognitive behavioral therapy in reducing the impairment caused by endometriosis.

Detailed description: Endometriosis is a chronic disease in which endometrium-like (uterine lining-like) cells settle outside the uterus in the abdomen (Dunselman et al., 2014). The Endometriose Vereinigung Deutschland reports that between eight and 15 percent of all women during reproductive age are affected and that there are 40,000 new cases annually in Germany (Endometriose Vereinigung Deutschland e.V., 2020). Thus, endometriosis is the second most common gynecological disease. Despite the high prevalence, the etiology and pathogenesis of many factors remains unclear. Misdiagnoses are common and to reach the correct diagnosis it takes an average of 5 to 8.9 years (Chaman-Ara, Bahrami \& Bahrami, 2017). So far there is no curative treatment option and the primarily medical treatment options are sometimes associated with serious side effects (Moradi, Parker, Sneddon, Lopez \& Ellwood, 2014). Endometriosis is characterized by a multitude of physical as well as considerable psychological symptoms that significantly reduce the quality of life of those affected (Gao et al., 2006). For example, endometriosis is associated with higher levels of depression and anxiety disorders (Pope, Sharma, Sharma \& Mazmanian, 2015). A psychotherapeutic supplement to the primary medical treatment to promote disease coping and expansion of coping strategies therefore appears sensible.

In the planned study, a CBT program specifically for endometriosis sufferers will therefore be developed and evaluated.

Previous intervention studies aimed at improving the quality of life of endometriosis sufferers examined mind-body interventions such as yoga (Gonçalves, Barros \& Bahamondes, 2017), relaxation training (Zhao et al., 2012) and acupuncture in combination with conversational psychotherapy (Meissner et al., 2016). Hansen et al. (2017) were able to show in an uncontrolled pilot study (N = 10) that mindfulness-based psychotherapy significantly reduces the burden of endometriosis. Overall, the number of psychological intervention studies on endometriosis is very low and their quality often requires a critical classification due to methodological limitations (for an overview see Evans, Fernandez, Olive, Payne \& Mikocka-Walus, 2019; Van Niekerk, Weaver-Pirie \& Matthewson, 2019). Numerous evidence of effectiveness from the area of chronic pain disorders (Williams, Fisher, Hearn \& Eccleston, 2020) as well as disorders in the area of women's health such as premenstrual dysphoric disorder (PMDD, Weise et al., 2019) undermine a possible effectiveness of CBT in endometriosis. To the best of our knowledge, however, there is no study to date that has tested the effectiveness of CBT for improving the quality of life of endometriosis sufferers.

The treatment program developed as part of the planned study is to be implemented as an internet-based intervention. A large number of studies confirm the effectiveness of internet-based CBT (iCBT) in various mental (Loughnan, Joubert, Grierson, Andrews \& Newby, 2019), psychosomatic (Andersson, Cuijpers, Carlbring, Riper \& Hedman, 2014) and somatopsychic diseases (Bernardy, Füber, Köllner \& Häuser, 2010). The iCBT has now established itself as being as effective as face-to-face therapy (Carlbring, Andersson, Cuijpers, Riper \& Hedman-Lagerlöf, 2018; Andersson, Carlbring \& Rozental, 2019)

The internet-based implementation in the present study has various advantages: On the one hand, the effectiveness of the iCBT can be checked efficiently and in a resource-saving manner (Hedman, Andersson, Ljoeétsson, Axelsson \& Lekander, 2016). On the other hand, endometriosis sufferers can be addressed throughout the German-speaking area, which ensures that a sufficient sample size can be achieved. Ultimately, those affected that would otherwise not receive any treatment due to the lack of regional availability of interventions, also have access to treatment. In addition, issues such as the desire to have children and endometriosis often lead to shame. An intervention offered online and anonymously can encourage the use of assistance here.

The aim of the study is to examine the effectiveness of iCBT in reducing the stress and impairment caused by endometriosis and in increasing the health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* People with female-assigned reproductive systems aged 18 to 45 years
* Medically confirmed endometriosis diagnosis
* Impairment of quality of life due to endometriosis defined as a value of ≥ 15 points across all scales in the Endometriosis Health Profile 30 + 23 (EHP-30 + 23, (Jones, Kennedy, Barnard, Wong \& Jenkinson, 2001a)
* Adequate German language skills
* Access to a personal computer (PC) / laptop and adequate internet connection

Exclusion Criteria:

* Serious mental disorder: unipolar severe depression (Beck Depression Inventory II: raw value ≥ 29), presuicidal syndrome, bipolar affective disorder, unipolar mania, psychotic disorder, alcohol or substance dependence
* Psychotherapeutic treatment: currently or within the last two years
* Use of benzodiazepines (prevents learning processes that are important for psychotherapy)
* Changes in the intake or use (e.g. start / change of dose / discontinuation) of antidepressants and hormonal contraceptives within the last three months
* Current or planned intrauterine insemination (IUI), in-vitro-fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment with hormonal stimulation within the next eight months
* Suffering from one of the following diseases: malignant tumor, in particular breast, cervical or ovarian cancer, ulcerative colitis, Crohn's disease, a known bacterial or viral infection (e.g. tuberculosis (TBC), hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV)
* Current pregnancy or birth of a child within the last six months, breastfeeding within the last six months

Primary outcomes:
measure: Change in Endometriosis Health Profile 30 + 23 (EHP-30 + 23; Jones, Kennedy, Barnard, Wong & Jenkinson, 2001)
timeFrame: Pre-treatment (baseline), post-treatment (change from basline at 8-10 weeks after treatment start), change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
measure: Change in Endometriosis Health Profile 5 (EHP-5; Jones, Jenkinson & Kennedy, 2004)
timeFrame: Pre-treatment (baseline), change from baseline weekly during treatment, change from basline at 8-10 weeks after treatment start, change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
measure: Change in Pain Disability Index (PDI; Tait, Pollard & Margolis, 1987)
timeFrame: Pre-treatment (baseline), post-treatment (change from basline at 8-10 weeks after treatment start), change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
measure: Change in Visual analog pain scale (VAS)
timeFrame: Pre-treatment (baseline), change from baseline weekly during treatment, change from basline at 8-10 weeks after treatment start, change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
Secondary outcomes:
measure: Change in Brief Patient Health Questionnaire (PHQ-9; Zipfel, Herzog & Löwe, 2004)
timeFrame: Pre-treatment (baseline), post-treatment (change from basline at 8-10 weeks after treatment start), change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
measure: Change in Perceived Stress Scale (PSS; Klein et al., 2016)
timeFrame: Pre-treatment (baseline), post-treatment (change from basline at 8-10 weeks after treatment start), change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
measure: Change in Brief Cope (Carver, 1997)
timeFrame: Pre-treatment (baseline), post-treatment (change from basline at 8-10 weeks after treatment start), change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
measure: Change in Illness Perception Questionnaire (IPQ-R; Glattacker, Bengel & Jäckel, 2009)
timeFrame: Pre-treatment (baseline), post-treatment (change from basline at 8-10 weeks after treatment start), change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
measure: Change in The Acceptance and Action Questionnaire - II (FAH-II; Hoyer & Gloster, 2013)
timeFrame: Pre-treatment (baseline), post-treatment (change from basline at 8-10 weeks after treatment start), change from baseline 3 month after treatment start, change from baseline 12 month after treatment start
Other outcomes:
measure: Relationship Assessment Scale (RAS; Hendrick, 1988)
timeFrame: Pre-treatment
measure: Big Five Inventory - 10 (BFI-10; Rammstedt & John, 2007)
timeFrame: Pre-treatment
measure: Negative Effects of Psychological Treatment Questionnaire (NEQ; Rozental, Kottorp, Boettcher & Andersson, 2016)
timeFrame: Post-treatment (8-10 weeks after treatment start), 3-month-follow-up, 12-month-follow-up
measure: Satisfaction with treatment (self developed questionnaire)
timeFrame: Weekly during treatment, post-treatment (8-10 weeks after treatment start), 3-month-follow-up, 12-month-follow-up
measure: Web-Based Screening Questionnaire (WSQ, Donker, Van Straten, Marks & Cuijpers, 2009)
timeFrame: Screening (up to 4 weeks before treatment start)
measure: International Diagnosis Checklist for International Classification of Diseases (ICD-10) (IDCL; Hiller et al., 2004)
timeFrame: Screening (up to 4 weeks before treatment start)
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Cornelia Weise, Ph.D
role: PRINCIPAL_INVESTIGATOR
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