Efficacy of Internet-based Cognitive Behavioral Therapy for Endometriosis

NCT05098444 | Active Not Recruiting

• 1 other identifier: CBT for endometriosis_2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Behavioral medicine; Internet based therapy; Cognitive behavioral therapy; Women's Health

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (6)

• Relationship Assessment Scale (RAS; Hendrick, 1988)

  Pre-treatment

• Big Five Inventory - 10 (BFI-10; Rammstedt & John, 2007)

  Pre-treatment

• 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

Study Arms (2)

Cognitive behavioral psychotherapy

EXPERIMENTAL

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

Waiting list

OTHER

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

Interventions

Cognitive behavioral psychotherapy BEHAVIORAL

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.

Cognitive behavioral psychotherapy

Waiting list OTHER

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

Waiting list

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

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

Marburg, Hesse, 35037, Germany

Location

Related Publications (35)

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  BACKGROUND

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MeSH Terms

Conditions

Endometriosis

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Cornelia Weise, Ph.D

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Model Details: Wait list control group

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 28, 2021
• Study Start: October 31, 2022
• Primary Completion: December 30, 2024
• Study Completion: July 31, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

DE (1)