Cognitive Behavioral Therapy in Endometriosis

November 16, 2023 updated by: Rijnstate Hospital

Cognitive Behavioral Therapy to Improve Quality of Life After Surgical Treatment of Women With Endometriosis

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).

Study Overview

Status

Active, not recruiting

Detailed Description

Rationale: 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. QoL after surgery for endometriosis should be improved. Pain cognitions could be psychosocial targets in the treatment of endometriosis related symptoms. We hypothesize that CBT focusing on cognitions towards pain for women undergoing surgery for endometriosis improves pain cognitions, leading to improvement of QoL.

Objective: 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.

Study design: 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).

Study population: Healthy female volunteers aged 18-50 years with an indication for endometriosis surgery due to endometriosis associated pain.

Intervention: Cognitive behavioral therapy administered in a total of seven sessions.

Main study parameters/endpoints: The difference in Quality of Life at the last measurement compared to baseline assessment.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The control group will receive usual care. The intervention group will receive usual treatment plus a total of seven sessions of CBT. In addition, all participants are asked to fill in seven questionnaires at baseline assessment, T1 (two weeks after completion of all CBT sessions) and T2 (follow-up): the EHP-30, SF-36, PSC, PASS, CIS, NRS and PSS. Furthermore, the researcher will carefully collect a scalp hair sample of at least 0,5 cm thickness. This will be done at baseline assessment, T1 and T2. The hair sample will be analyzed for cortisol levels in a laboratory.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Rijnstate Hospital
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboud university medical center
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • An mood, anxiety or personality disorder diagnosis according to the DSM-5 at the moment of inclusion
  • Undergoing psychological treatment at the moment of inclusion
  • Use of psychopharmacologic medication aimed at altering mood at the moment of inclusion Patients that have endometriosis-related unwanted childlessness only
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavioral therapy group
Patients in this group will undergo a total of 7 sessions of CBT in 5 months in addition to usual care.
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.
No Intervention: Usual care
Patients in this group will undergo usual care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30
Time Frame: 7,5 months

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
Time Frame: 7,5 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain intensity assessed by the Numerical Rating Scale
Time Frame: 7,5 months

The Numerical Rating Scale (NRS) ranges from 0 (no pain) to 10 (unbearable pain), and is the most commonly used subjective measure to assess pain intensity. Patients will score there estimated average pain intensity and there highest pain intensity of the previous 7 days.

Minimum value: 0 Maximum value: 20 Higher score indicates a higher level of pain intensity.

7,5 months
Change in Subjective stress assessed by the Perceived Stress Scale
Time Frame: 7,5 months

Perceived stress will be measured using the Perceived Stress Scale (PSS), a 10-item validated psychological instrument for measuring nonspecific perceived stress. Items are designed to score how unpredictable, uncontrollable, and overloaded respondents find their lives.

Minimum value: 10 Maximum value: 50 Higher score indicates a higher level of perceived stress.

7,5 months
Change in Objective stress assessed by measuring scalp hair cortisol levels
Time Frame: 7,5 months
Cortisol will be extracted from hair. The researcher will carefully collect a scalp hair sample of at least 0,5 cm thickness and sent these to the laboratory to analyze. The most proximal part represents the most recently grown piece of hair. Hair samples will be cut into a segment corresponding to the 4 cm closest to the scalp, reflecting cortisol secretion over the four months prior to sample collection. Cortisol extraction from hair will be carried out using an enzyme-linked immunoassay (ELISA).
7,5 months
Changes in pain cognitions assessed by the Pain anxiety symptom scale
Time Frame: 7,5 months

The Pain anxiety symptom scale (PASS) measures anxiety caused by pain. Questions are asked about feelings of fear of pain, cognitive anxiety, avoidance behaviour, and physiological anxiety symptoms.

Minimum value: 0 Maximum value: 200 Higher score indicates a higher pain anxiety.

7,5 months
Changes in pain cognitions assessed by the pain catastrophizing Scale
Time Frame: 7,5 months

The pain catastrophizing Scale (PCS) measures the degree of pain catastrophizing of the participant by measuring elements of helplessness and pessimism in relation to the ability to cope with the pain experience.

Minimum value: 0 Maximum value: 52 Higher score indicates a higher level of catastrophizing

7,5 months
Changes in Fatigue assessed by the checklist individual strength
Time Frame: 7,5 months

The checklist Individual Strength (CIS) is a 20-item questionnaire addressing fatigue, concentration, motivation and activity over the past two weeks.

The CIS is not a numerical scale.

7,5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: A W Nap, MSc, PhD, Rijnstate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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