Efficacy of Internet-based Cognitive Behavioral Therapy for Endometriosis

Endometriosis Clinical Trial

— EdiTh  

Official title:

Endometriosis - Internet-based Therapy (Ed.iTh): Evaluation of an Internet-based Cognitive Behavioral Treatment to Improve the Quality of Life With Endometriosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098444
• Other study ID #: CBT for endometriosis_2021
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Philipps University Marburg Medical Center
• Contact: Cornelia Weise, Ph.D
• Phone: +49-6421-2826738
• Email: weise[@]uni-marburg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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
Participants of the waiting list receive no treatment for 5 months. Afterwards they receive the same treatment as the experimental group.

Locations

Country	Name	City	State
Germany	Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

References & Publications (34)

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Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014 Oct;13(3):288-95. doi: 10.1002/ — View Citation

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Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: — View Citation

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Goncalves AV, Barros NF, Bahamondes L. The Practice of Hatha Yoga for the Treatment of Pain Associated with Endometriosis. J Altern Complement Med. 2017 Jan;23(1):45-52. doi: 10.1089/acm.2015.0343. Epub 2016 Nov 21. — View Citation

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Hansen, K. E., Kesmodel, U. S., Kold, M. & Forman, A. (2017). Long-term effects of mindfulness-based psychological intervention for coping with pain in endometriosis: A six-year follow-up on a pilot study. Nordic Psychology, 69(2), 100-109. Routledge. htt

Hedman E, Andersson E, Ljotsson B, Axelsson E, Lekander M. Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety. BMJ Open. 2016 Apr 25;6(4):e009327. doi: 10.1136/bmjopen-2015-009327. — View Citation

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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. doi: 10.1023/B:QURE.0000021321.48041.0e. — View Citation

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. doi: 10.1016/s0029-7844(01)01433-8. — View Citation

Klein EM, Brahler E, Dreier M, Reinecke L, Muller KW, Schmutzer G, Wolfling 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. — View Citation

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Pope CJ, Sharma V, Sharma S, Mazmanian D. A Systematic Review of the Association Between Psychiatric Disturbances and Endometriosis. J Obstet Gynaecol Can. 2015 Nov;37(11):1006-15. doi: 10.1016/s1701-2163(16)30050-0. — View Citation

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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. — View Citation

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Weise C, Kaiser G, Janda C, Kues JN, Andersson G, Strahler J, Kleinstauber M. Internet-Based Cognitive-Behavioural Intervention for Women with Premenstrual Dysphoric Disorder: A Randomized Controlled Trial. Psychother Psychosom. 2019;88(1):16-29. doi: 10. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship Assessment Scale (RAS; Hendrick, 1988)	Assessment of quality of partnership (self-rating)	Pre-treatment
Other	Big Five Inventory - 10 (BFI-10; Rammstedt & John, 2007)	Assessment of personality factors (self-rating)	Pre-treatment
Other	Negative Effects of Psychological Treatment Questionnaire (NEQ; Rozental, Kottorp, Boettcher & Andersson, 2016)	Assessment of side effects of the intervention (self-rating)	Post-treatment (8-10 weeks after treatment start), 3-month-follow-up, 12-month-follow-up
Other	Satisfaction with treatment (self developed questionnaire)	Assessment of satisfaction with treatment (self-rating)	Weekly during treatment, post-treatment (8-10 weeks after treatment start), 3-month-follow-up, 12-month-follow-up
Other	Web-Based Screening Questionnaire (WSQ, Donker, Van Straten, Marks & Cuijpers, 2009)	Assessment of inclusion and exclusion criteria	Screening (up to 4 weeks before treatment start)
Other	International Diagnosis Checklist for International Classification of Diseases (ICD-10) (IDCL; Hiller et al., 2004)	Telephone interview, assessment of inclusion and exclusion criteria	Screening (up to 4 weeks before treatment start)
Primary	Change in Endometriosis Health Profile 30 + 23 (EHP-30 + 23; Jones, Kennedy, Barnard, Wong & Jenkinson, 2001)	Assessment of impairment of endometriosis-related quality of life (long version)(self-rating)	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
Primary	Change in Endometriosis Health Profile 5 (EHP-5; Jones, Jenkinson & Kennedy, 2004)	Assessment of impairment of endometriosis-related quality of life (short version)(self-rating)	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
Primary	Change in Pain Disability Index (PDI; Tait, Pollard & Margolis, 1987)	Assessment of impairment due to pain (self-rating)	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
Primary	Change in Visual analog pain scale (VAS)	Assessment of impairment due to pain during menstruation and at the moment (self-rating)	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	Change in Brief Patient Health Questionnaire (PHQ-9; Zipfel, Herzog & Löwe, 2004)	Assessment of depressive mood (self-rating)	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
Secondary	Change in Perceived Stress Scale (PSS; Klein et al., 2016)	Assessment of perceived stress (self-rating)	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
Secondary	Change in Brief Cope (Carver, 1997)	Assessment of coping skills (self-rating)	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
Secondary	Change in Illness Perception Questionnaire (IPQ-R; Glattacker, Bengel & Jäckel, 2009)	Assessment of cognitive representation of illness (self-rating)	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
Secondary	Change in The Acceptance and Action Questionnaire - II (FAH-II; Hoyer & Gloster, 2013)	Assessment of psychological flexibility (self-rating)	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