EdiTh: Efficacy of Internet-based Cognitive Behavioral Therapy for Endometriosis

• Sponsor: Philipps University Marburg Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05098444
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Behavioral: Cognitive behavioral psychotherapy; Other: Waiting list	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Wait list control groupWait list control group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endometriosis - Internet-based Therapy (Ed.iTh): Evaluation of an Internet-based Cognitive Behavioral Treatment to Improve the Quality of Life With Endometriosis
• Anticipated Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive behavioral psychotherapy Internet-based CBT for patients with endometriosis: The experimental group has access to an online training consisting of 8 modules, one per week. Modules comprise of 1) psychoeducation (e.g., information about endometriosis and its treatment); 2) & 3) cognitive strategies (e.g., identifying and modifying dysfunctional cognitions); 4&5) pain and stress management (e.g. activity plans, relaxation techniques); 6) emotion regulation strategies (e.g. recognition and acceptance of emotions); 7) communication training (e.g. detection and communication of needs); 8) prophylaxis (e.g. summary of intervention, plans for the future). Participants are in weekly written contact with their assigned therapist via the news function of the training platform, receiving feedback on the content or getting answers to open questions.	Behavioral: Cognitive behavioral psychotherapy; Internet-based Cognitive Behavioural Therapy aims to reduce the impairment due to endometriosis by using cognitive behavioural intervention techniques. Furthermore, therapy should enable the patients in coping with symptoms in the future.
Other: Waiting list During the waiting period, patients receive no treatment. After a waiting time of 5 months, patients of the waitlist receive the same iCBT treatment as the experimental group.	Other: Waiting list; Participants of the waiting list receive no treatment for 5 months. Afterwards they receive the same treatment as the experimental group.

Outcome Measures

Primary Outcome Measures

1. Change in Endometriosis Health Profile 30 + 23 (EHP-30 + 23; Jones, Kennedy, Barnard, Wong & Jenkinson, 2001) [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]

   Assessment of impairment of endometriosis-related quality of life (long version)(self-rating)

2. Change in Endometriosis Health Profile 5 (EHP-5; Jones, Jenkinson & Kennedy, 2004) [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]

   Assessment of impairment of endometriosis-related quality of life (short version)(self-rating)

3. Change in Pain Disability Index (PDI; Tait, Pollard & Margolis, 1987) [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]

   Assessment of impairment due to pain (self-rating)

4. Change in Visual analog pain scale (VAS) [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]

   Assessment of impairment due to pain during menstruation and at the moment (self-rating)

Secondary Outcome Measures

1. Change in Brief Patient Health Questionnaire (PHQ-9; Zipfel, Herzog & Löwe, 2004) [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]

   Assessment of depressive mood (self-rating)

2. Change in Perceived Stress Scale (PSS; Klein et al., 2016) [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]

   Assessment of perceived stress (self-rating)

3. Change in Brief Cope (Carver, 1997) [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]

   Assessment of coping skills (self-rating)

4. Change in Illness Perception Questionnaire (IPQ-R; Glattacker, Bengel & Jäckel, 2009) [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]

   Assessment of cognitive representation of illness (self-rating)

5. Change in The Acceptance and Action Questionnaire - II (FAH-II; Hoyer & Gloster, 2013) [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]

   Assessment of psychological flexibility (self-rating)

Other Outcome Measures

1. Relationship Assessment Scale (RAS; Hendrick, 1988) [Pre-treatment]

   Assessment of quality of partnership (self-rating)

2. Big Five Inventory - 10 (BFI-10; Rammstedt & John, 2007) [Pre-treatment]

   Assessment of personality factors (self-rating)

3. Negative Effects of Psychological Treatment Questionnaire (NEQ; Rozental, Kottorp, Boettcher & Andersson, 2016) [Post-treatment (8-10 weeks after treatment start), 3-month-follow-up, 12-month-follow-up]

   Assessment of side effects of the intervention (self-rating)

4. Satisfaction with treatment (self developed questionnaire) [Weekly during treatment, post-treatment (8-10 weeks after treatment start), 3-month-follow-up, 12-month-follow-up]

   Assessment of satisfaction with treatment (self-rating)

5. Web-Based Screening Questionnaire (WSQ, Donker, Van Straten, Marks & Cuijpers, 2009) [Screening (up to 4 weeks before treatment start)]

   Assessment of inclusion and exclusion criteria

6. International Diagnosis Checklist for International Classification of Diseases (ICD-10) (IDCL; Hiller et al., 2004) [Screening (up to 4 weeks before treatment start)]

   Telephone interview, assessment of inclusion and exclusion criteria

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy	Marburg	Hessen	Germany	35037

Sponsors and Collaborators

• Philipps University Marburg Medical Center

Investigators

• Principal Investigator: Cornelia Weise, Ph.D, Philipps University Marburg Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100.
• Donker T, van Straten A, Marks I, Cuijpers P. A brief Web-based screening questionnaire for common mental disorders: development and validation. J Med Internet Res. 2009 Jul 24;11(3):e19. doi: 10.2196/jmir.1134.
• Endometriose Vereinigung Deutschland e.V. (2020). Was ist Endometriose? Zugriff am 21.12.2020. Verfügbar unter: https://www.endometriose-vereinigung.de/was-ist-endometriose.html
• Glattacker, M., Bengel, J. & Jäckel, W. H. (2009). Die deutschsprachige Version des Illness Perception Questionnaire-revised: Psychometrische Evaluation an Patienten mit chronisch somatischen Erkrankungen. Zeitschrift fur Gesundheitspsychologie, 17(4), 158-169. Hogrefe Verlag Göttingen . https://doi.org/10.1026/0943-8149.17.4.158
• Hahlweg, K. (1979). Konstruktion und Validierung des Partnerschaftsfragebogen PFB. Zeitschrift für Klinische Psychologie, 8(1).
• Hendrick, S. S. (1988). A Generic Measure of Relationship Satisfaction. Journal of Marriage and the Family, 50(1), 93. https://doi.org/10.2307/352430
• Hiller, W., Zaudig, M. & Mombour, W. (2004). IDCL-Internationale Diagnosen Checklisten für DSM-IV und ICD-10 [Inter-national Diagnostic Checklists for DSM-IV and ICD-10] (Band 2). Bern: Huber.
• Hoyer, J. & Gloster, A. T. (2013). Fragebögen und Skalen · Questionnaires and Scales Verhaltenstherapie 2013;23:42-44 Psychologische Flexibilität messen: Der Fragebogen zu Akzeptanz und Handeln II. https://doi.org/10.1159/000347040
• Jones G, Jenkinson C, Kennedy S. Development of the Short Form Endometriosis Health Profile Questionnaire: the EHP-5. Qual Life Res. 2004 Apr;13(3):695-704.
• Jones G, Kennedy S, Barnard A, Wong J, Jenkinson C. Development of an endometriosis quality-of-life instrument: The Endometriosis Health Profile-30. Obstet Gynecol. 2001 Aug;98(2):258-64.
• Klein EM, Brähler E, Dreier M, Reinecke L, Müller KW, Schmutzer G, Wölfling K, Beutel ME. The German version of the Perceived Stress Scale - psychometric characteristics in a representative German community sample. BMC Psychiatry. 2016 May 23;16:159. doi: 10.1186/s12888-016-0875-9.
• Rammstedt, B. & John, O. P. (2007). Measuring personality in one minute or less: A 10-item short version of the Big Five Inventory in English and German. Journal of Research in Personality, 41, 203-212. https://doi.org/10.1016/j.jrp.2006.02.001
• Rozental A, Kottorp A, Boettcher J, Andersson G, Carlbring P. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events. PLoS One. 2016 Jun 22;11(6):e0157503. doi: 10.1371/journal.pone.0157503. eCollection 2016.
• Tait RC, Pollard CA, Margolis RB, Duckro PN, Krause SJ. The Pain Disability Index: psychometric and validity data. Arch Phys Med Rehabil. 1987 Jul;68(7):438-41.
• Zipfel, S., Herzog, W. & Löwe, B. (2004). Screening psychischer Störungen mit dem "Gesundheitsfragebogen für Patienten (PHQ-D)". Diagnostica, 50(4), 171-181. https://doi.org/10.1026/0012-1924.50.4.171

• Responsible Party: Cornelia Weise, Dr. rer. nat., Philipps University Marburg Medical Center
• ClinicalTrials.gov Identifier: NCT05098444
• Other Study ID Numbers: CBT for endometriosis_2021
• First Posted: Oct 28, 2021
• Last Update Posted: Oct 28, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cornelia Weise, Dr. rer. nat., Philipps University Marburg Medical Center: Endometriosis; Behavioral medicine; Internet based therapy; Cognitive behavioral therapy; Women's Health
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Oct 28, 2021