Cognitive Behavioral Therapy in Endometriosis

NCT04448366 | Completed

• 1 other identifier: 2019-1464
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

Endometriosis affects 10% of reproductive aged women and causes severe pain and impaired quality of life (QoL). Surgery for endometriosis results in long term symptom relief in only 40% of women. QoL in endometriosis improves after surgery, but not to the level of healthy women. Mediators in QoL include pain intensity, pain cognitions, and stress. In a preliminary study, patients with negative pain cognitions reported higher pain intensities compared to patients with positive pain cognitions. This indicates that psychological factors explain considerable variance in pain, suggesting that changing these factors by psychological interventions may contribute to improving QoL. Cognitive behavioral therapy (CBT) is proven effective as a psychological treatment for pain-related symptoms. The primary objective of this study is to investigate whether usual care combined with CBT improves QoL in patients undergoing surgery for endometriosis compared to usual care only. Secondary objectives are to investigate whether pain intensity, pain cognitions, perceived stress, fatigue and objectively measured cortisol levels mediate the effects of CBT on QoL in both groups. In a randomized controlled trial, 100 endometriosis patients undergoing surgery will be randomized between usual care with CBT (CBT group) and usual care only (control group). Women in the CBT group will receive, in addition to usual care, one pre-surgery and six post-surgery sessions of CBT, aimed at positively influencing mediators of QoL. Women in the control group will receive only usual care. Follow-up will be 7,5 months. In both groups QoL, pain intensity, pain cognitions, fatigue, perceived stress (using questionnaires) and objective stress (assessing cortisol in a hair sample) will be assessed at baseline assessment, T1 (two weeks after completion of all CBT sessions) and T2 (follow-up). Recruitment and treatment of patients will take place in Rijnstate hospital and Radboud University Medical Center (UMC).

Conditions

Endometriosis; Quality of Life; Pain

Keywords

Endometriosis; Cognitive behavioral therapy; Quality of life

Outcome Measures

Primary Outcomes (2)

• Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30

  The Endometriosis Health Profile 30 (EHP-30) is a disease-specific QoL questionnaire which is validated for use in endometriosis patients and measures the impact of the disease on physical, mental and social aspects of life. The EHP-30 is not a numerical scale.

  7,5 months

• Change in general Quality of Life assessed by the Short Form 36

  The Short Form 36 (SF-36) is a multipurpose, general health survey which is applied to measure QoL on nine different domains: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, emotional well-being, vitality, pain, general health, and health change. The SF-36 is not a numerical scale.

  7,5 months

Secondary Outcomes (6)

• Change in Pain intensity assessed by the Numerical Rating Scale

  7,5 months

• Change in Subjective stress assessed by the Perceived Stress Scale

  7,5 months

• Change in Objective stress assessed by measuring scalp hair cortisol levels

  7,5 months

• Changes in pain cognitions assessed by the Pain anxiety symptom scale

  7,5 months

• Changes in pain cognitions assessed by the pain catastrophizing Scale

  7,5 months

Study Arms (2)

Cognitive behavioral therapy group

EXPERIMENTAL

Patients in this group will undergo a total of 7 sessions of CBT in 5 months in addition to usual care.

Behavioral: Cognitive behavioral therapy

Usual care

NO INTERVENTION

Patients in this group will undergo usual care only.

Interventions

Cognitive behavioral therapy BEHAVIORAL

Patients in the CBT group will receive usual care. In addition, they will undergo one pre-surgery and six post-surgery face-to-face sessions of CBT. In the pre-surgery session, management of expectations towards surgery will be addressed. In the six post-surgery sessions, attention will be paid to psycho-education concerning the biological link between endometriosis-related pain and stress, relaxation training, cognitive stress management, and management of anxiety, catastrophizing and hypervigilance. The CBT sessions will be coordinated by a registered psychotherapist who is experienced in CBT and has knowledge about endometriosis. All CBT will be individual sessions.

Cognitive behavioral therapy group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 50 years
• Proven endometriosis (by ultrasound, MRI or surgery)
• An indication for endometriosis debulking surgery\* due to endometriosis-related pain
• Being able to understand, read and write Dutch \* An indication for surgery is present when hormonal and/or analgesic therapy failed in suppressing pain symptoms.

You may not qualify if:

• Chronic pain (3 days a week for at least 6 months) that can be allocated to other diseases or syndromes
• Scalp hair shorter than 4 cm

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Radboud University Medical Center: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Jeroen Bosch Ziekenhuis: collaborator
• Isala: collaborator

Study Sites (5)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Isala Hospital

Zwolle, Overijsel, 8025AB, Netherlands

Location

Related Publications (10)

• van Aken MAW, Oosterman JM, van Rijn CM, Ferdek MA, Ruigt GSF, Peeters BWMM, Braat DDM, Nap AW. Pain cognition versus pain intensity in patients with endometriosis: toward personalized treatment. Fertil Steril. 2017 Oct;108(4):679-686. doi: 10.1016/j.fertnstert.2017.07.016. Epub 2017 Sep 11.

  PMID: 28911933 BACKGROUND

• van Aken M, Oosterman J, van Rijn T, Ferdek M, Ruigt G, Kozicz T, Braat D, Peeters A, Nap A. Hair cortisol and the relationship with chronic pain and quality of life in endometriosis patients. Psychoneuroendocrinology. 2018 Mar;89:216-222. doi: 10.1016/j.psyneuen.2018.01.001. Epub 2018 Jan 5.

  PMID: 29414035 BACKGROUND

• Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.

  PMID: 15541453 BACKGROUND

• Soliman AM, Yang H, Du EX, Kelley C, Winkel C. The direct and indirect costs associated with endometriosis: a systematic literature review. Hum Reprod. 2016 Apr;31(4):712-22. doi: 10.1093/humrep/dev335. Epub 2016 Feb 6.

  PMID: 26851604 BACKGROUND

• Ehde DM, Dillworth TM, Turner JA. Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Am Psychol. 2014 Feb-Mar;69(2):153-66. doi: 10.1037/a0035747.

  PMID: 24547801 BACKGROUND

• Faramarzi M, Pasha H, Esmailzadeh S, Kheirkhah F, Heidary S, Afshar Z. The effect of the cognitive behavioral therapy and pharmacotherapy on infertility stress: a randomized controlled trial. Int J Fertil Steril. 2013 Oct;7(3):199-206. Epub 2013 Sep 18.

  PMID: 24520487 BACKGROUND

• Richter J, Bittner A, Petrowski K, Junge-Hoffmeister J, Bergmann S, Joraschky P, Weidner K. Effects of an early intervention on perceived stress and diurnal cortisol in pregnant women with elevated stress, anxiety, and depressive symptomatology. J Psychosom Obstet Gynaecol. 2012 Dec;33(4):162-70. doi: 10.3109/0167482X.2012.729111. Epub 2012 Oct 19.

  PMID: 23078196 BACKGROUND

• Archer KR, Devin CJ, Vanston SW, Koyama T, Phillips SE, Mathis SL, George SZ, McGirt MJ, Spengler DM, Aaronson OS, Cheng JS, Wegener ST. Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial. J Pain. 2016 Jan;17(1):76-89. doi: 10.1016/j.jpain.2015.09.013. Epub 2015 Oct 23.

  PMID: 26476267 BACKGROUND

• Wang L, Chang Y, Kennedy SA, Hong PJ, Chow N, Couban RJ, McCabe RE, Bieling PJ, Busse JW. Perioperative psychotherapy for persistent post-surgical pain and physical impairment: a meta-analysis of randomised trials. Br J Anaesth. 2018 Jun;120(6):1304-1314. doi: 10.1016/j.bja.2017.10.026. Epub 2018 Feb 14.

  PMID: 29793597 BACKGROUND

• Boersen Z, Oosterman J, Hameleers EG, Delcliseur HSMJ, Lutters C, IJssel de Schepper A, Braat D, Verhaak CM, Nap A. Determining the effectiveness of cognitive behavioural therapy in improving quality of life in patients undergoing endometriosis surgery: a study protocol for a randomised controlled trial. BMJ Open. 2021 Dec 8;11(12):e054896. doi: 10.1136/bmjopen-2021-054896.

  PMID: 34880026 DERIVED

MeSH Terms

Conditions

Endometriosis; Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• A W Nap, MSc, PhD

  Rijnstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 25, 2020
• Study Start: November 24, 2020
• Primary Completion: August 15, 2024
• Study Completion: October 10, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)