Clinical trial NCT04448366: Cognitive Behavioral Therapy in Endometriosis
Official title: Cognitive Behavioral Therapy to Improve Quality of Life After Surgical Treatment of Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Quality of Life
Pain
Keywords: Endometriosis
Cognitive behavioral therapy
Quality of life
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Catharina Ziekenhuis Eindhoven
name: Jeroen Bosch Ziekenhuis
name: Isala
First posted: 2020-06-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30
timeFrame: 7,5 months
measure: Change in general Quality of Life assessed by the Short Form 36
timeFrame: 7,5 months
Secondary outcomes:
measure: Change in Pain intensity assessed by the Numerical Rating Scale
timeFrame: 7,5 months
measure: Change in Subjective stress assessed by the Perceived Stress Scale
timeFrame: 7,5 months
measure: Change in Objective stress assessed by measuring scalp hair cortisol levels
timeFrame: 7,5 months
measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale
timeFrame: 7,5 months
measure: Changes in pain cognitions assessed by the pain catastrophizing Scale
timeFrame: 7,5 months
measure: Changes in Fatigue assessed by the checklist individual strength
timeFrame: 7,5 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Hospital
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
city: Zwolle
country: Netherlands
facility: Isala Hospital
state: Overijsel
Study officials:
affiliation: Rijnstate
name: A W Nap, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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