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EndometriosisEdiThNCT05098444

Efficacy of Internet-based Cognitive Behavioral Therapy for Endometriosis

A study testing Cognitive behavioral psychotherapy and Waiting list in people with Endometriosis, run by Philipps University Marburg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
Cognitive behavioral psychotherapy and Waiting list
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteGermany
Study dates
31 Oct 2022to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Philipps University Marburg, Dept. of Psychology, Division of Clinical Psychology and Psychotherapy

    Marburg, Hesse, 35037

Other trials in Germany

About this study

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

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

Read the 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.

Conditions
Endometriosis
Being tested
Cognitive behavioral psychotherapy, Waiting list
Keywords
Endometriosis, Behavioral medicine, Internet based therapy, Cognitive behavioral therapy, Women's Health
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavioral psychotherapyBehavioural

    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.

  • Waiting listOther

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

Study groups in NCT05098444
Study groupRoleWhat they receive
Cognitive behavioral psychotherapyExperimentalInternet-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.
Receives: Behavioral: Cognitive behavioral psychotherapy
Waiting listOtherDuring 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.
Receives: Other: Waiting list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 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

  2. 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)

    Measured: 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

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

    Assessment of impairment due to pain (self-rating)

    Measured: 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

  4. Change in Visual analog pain scale (VAS)

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

    Measured: 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 (5)

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

    Assessment of depressive mood (self-rating)

    Measured: 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

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

    Assessment of perceived stress (self-rating)

    Measured: 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

  3. Change in Brief Cope (Carver, 1997)

    Assessment of coping skills (self-rating)

    Measured: 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

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

    Assessment of cognitive representation of illness (self-rating)

    Measured: 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

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

    Assessment of psychological flexibility (self-rating)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start31 Oct 2022
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Wait list control group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098444
Sponsor's protocol ID
CBT for endometriosis_2021
Acronym
EdiTh
Status last verified
Aug 2024
First submitted
16 Aug 2021
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Depends on the sample size. Patient data are highly sensible and anonymization might be threatened if the sample size is too small.

Publications

  • 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.

    PubMed 27216151

  • 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.

    PubMed 11506842

  • 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.

    PubMed 15130031

  • 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

  • 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.

  • Hahlweg, K. (1979). Konstruktion und Validierung des Partnerschaftsfragebogen PFB. Zeitschrift für Klinische Psychologie, 8(1).

  • 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

  • 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.

    PubMed 19632977

  • 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. doi: 10.1207/s15327558ijbm0401_6.

    PubMed 16250744

  • 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.

    PubMed 27331907

  • 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.

    PubMed 3606368

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive behavioral psychotherapy and Waiting list in people with Endometriosis, run by Philipps University Marburg at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Endometriosis Health Profile 30 + 23 (EHP-30 + 23; Jones, Kennedy, Barnard, Wong & Jenkinson, 2001) (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098444, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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