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NCT Number: NCT04448366

Cognitive Behavioral Therapy in 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).

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital, Arnhem, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven
  • Isala
  • Jeroen Bosch Ziekenhuis
  • Radboud University Medical Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2020
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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