<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448366</url>
  </required_header>
  <id_info>
    <org_study_id>2019-1464</org_study_id>
    <nct_id>NCT04448366</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy in Endometriosis</brief_title>
  <official_title>Cognitive Behavioral Therapy to Improve Quality of Life After Surgical Treatment of Women With Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rijnstate Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endometriosis affects 10% of reproductive aged women and causes severe pain and impaired&#xD;
      quality of life (QoL). Surgery for endometriosis results in long term symptom relief in only&#xD;
      40% of women.&#xD;
&#xD;
      QoL in endometriosis improves after surgery, but not to the level of healthy women. Mediators&#xD;
      in QoL include pain intensity, pain cognitions, and stress. In a preliminary study, patients&#xD;
      with negative pain cognitions reported higher pain intensities compared to patients with&#xD;
      positive pain cognitions. This indicates that psychological factors explain considerable&#xD;
      variance in pain, suggesting that changing these factors by psychological interventions may&#xD;
      contribute to improving QoL. Cognitive behavioral therapy (CBT) is proven effective as a&#xD;
      psychological treatment for pain-related symptoms. The primary objective of this study is to&#xD;
      investigate whether usual care combined with CBT improves QoL in patients undergoing surgery&#xD;
      for endometriosis compared to usual care only. Secondary objectives are to investigate&#xD;
      whether pain intensity, pain cognitions, perceived stress, fatigue and objectively measured&#xD;
      cortisol levels mediate the effects of CBT on QoL in both groups.&#xD;
&#xD;
      In a randomized controlled trial, 100 endometriosis patients undergoing surgery will be&#xD;
      randomized between usual care with CBT (CBT group) and usual care only (control group). Women&#xD;
      in the CBT group will receive, in addition to usual care, one pre-surgery and six&#xD;
      post-surgery sessions of CBT, aimed at positively influencing mediators of QoL. Women in the&#xD;
      control group will receive only usual care. Follow-up will be 7,5 months. In both groups QoL,&#xD;
      pain intensity, pain cognitions, fatigue, perceived stress (using questionnaires) and&#xD;
      objective stress (assessing cortisol in a hair sample) will be assessed at baseline&#xD;
      assessment, T1 (two weeks after completion of all CBT sessions) and T2 (follow-up).&#xD;
      Recruitment and treatment of patients will take place in Rijnstate hospital and Radboud&#xD;
      University Medical Center (UMC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Endometriosis affects 10% of reproductive aged women and causes severe pain and&#xD;
      impaired quality of life (QoL). Surgery for endometriosis results in long term symptom relief&#xD;
      in only 40% of women. QoL in endometriosis improves after surgery, but not to the level of&#xD;
      healthy women. Mediators in QoL include pain intensity, pain cognitions, and stress. In a&#xD;
      preliminary study, patients with negative pain cognitions reported higher pain intensities&#xD;
      compared to patients with positive pain cognitions. This indicates that psychological factors&#xD;
      explain considerable variance in pain, suggesting that changing these factors by&#xD;
      psychological interventions may contribute to improving QoL. Cognitive behavioral therapy&#xD;
      (CBT) is proven effective as a psychological treatment for pain-related symptoms. QoL after&#xD;
      surgery for endometriosis should be improved. Pain cognitions could be psychosocial targets&#xD;
      in the treatment of endometriosis related symptoms. We hypothesize that CBT focusing on&#xD;
      cognitions towards pain for women undergoing surgery for endometriosis improves pain&#xD;
      cognitions, leading to improvement of QoL.&#xD;
&#xD;
      Objective: The primary objective of this study is to investigate whether usual care combined&#xD;
      with CBT improves QoL in patients undergoing surgery for endometriosis compared to usual care&#xD;
      only. Secondary objectives are to investigate whether pain intensity, pain cognitions,&#xD;
      perceived stress, fatigue and objectively measured cortisol levels mediate the effects of CBT&#xD;
      on QoL in both groups.&#xD;
&#xD;
      Study design: In a randomized controlled trial, 100 endometriosis patients undergoing surgery&#xD;
      will be randomized between usual care with CBT (CBT group) and usual care only (control&#xD;
      group). Women in the CBT group will receive, in addition to usual care, one pre-surgery and&#xD;
      six post-surgery sessions of CBT, aimed at positively influencing mediators of QoL. Women in&#xD;
      the control group will receive only usual care. Follow-up will be 7,5 months. In both groups&#xD;
      QoL, pain intensity, pain cognitions, fatigue, perceived stress (using questionnaires) and&#xD;
      objective stress (assessing cortisol in a hair sample) will be assessed at baseline&#xD;
      assessment, T1 (two weeks after completion of all CBT sessions) and T2 (follow-up).&#xD;
      Recruitment and treatment of patients will take place in Rijnstate hospital and Radboud&#xD;
      University Medical Center (UMC).&#xD;
&#xD;
      Study population: Healthy female volunteers aged 18-50 years with an indication for&#xD;
      endometriosis surgery due to endometriosis associated pain.&#xD;
&#xD;
      Intervention: Cognitive behavioral therapy administered in a total of seven sessions.&#xD;
&#xD;
      Main study parameters/endpoints: The difference in Quality of Life at the last measurement&#xD;
      compared to baseline assessment.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: The control group will receive usual care. The intervention group will receive&#xD;
      usual treatment plus a total of seven sessions of CBT. In addition, all participants are&#xD;
      asked to fill in seven questionnaires at baseline assessment, T1 (two weeks after completion&#xD;
      of all CBT sessions) and T2 (follow-up): the EHP-30, SF-36, PSC, PASS, CIS, NRS and PSS.&#xD;
      Furthermore, the researcher will carefully collect a scalp hair sample of at least 0,5 cm&#xD;
      thickness. This will be done at baseline assessment, T1 and T2. The hair sample will be&#xD;
      analyzed for cortisol levels in a laboratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 24, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30</measure>
    <time_frame>7,5 months</time_frame>
    <description>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.&#xD;
The EHP-30 is not a numerical scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in general Quality of Life assessed by the Short Form 36</measure>
    <time_frame>7,5 months</time_frame>
    <description>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.&#xD;
The SF-36 is not a numerical scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pain intensity assessed by the Numerical Rating Scale</measure>
    <time_frame>7,5 months</time_frame>
    <description>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.&#xD;
Minimum value: 0 Maximum value: 20 Higher score indicates a higher level of pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Subjective stress assessed by the Perceived Stress Scale</measure>
    <time_frame>7,5 months</time_frame>
    <description>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.&#xD;
Minimum value: 10 Maximum value: 50 Higher score indicates a higher level of perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Objective stress assessed by measuring scalp hair cortisol levels</measure>
    <time_frame>7,5 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain cognitions assessed by the Pain anxiety symptom scale</measure>
    <time_frame>7,5 months</time_frame>
    <description>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.&#xD;
Minimum value: 0 Maximum value: 200 Higher score indicates a higher pain anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain cognitions assessed by the pain catastrophizing Scale</measure>
    <time_frame>7,5 months</time_frame>
    <description>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.&#xD;
Minimum value: 0 Maximum value: 52 Higher score indicates a higher level of catastrophizing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Fatigue assessed by the checklist individual strength</measure>
    <time_frame>7,5 months</time_frame>
    <description>The checklist Individual Strength (CIS) is a 20-item questionnaire addressing fatigue, concentration, motivation and activity over the past two weeks.&#xD;
The CIS is not a numerical scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Endometriosis</condition>
  <condition>Quality of Life</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Cognitive behavioral therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will undergo a total of 7 sessions of CBT in 5 months in addition to usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will undergo usual care only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>Cognitive behavioral therapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 50 years&#xD;
&#xD;
          -  Proven endometriosis (by ultrasound, MRI or surgery)&#xD;
&#xD;
          -  An indication for endometriosis debulking surgery* due to endometriosis-related pain&#xD;
&#xD;
          -  Being able to understand, read and write Dutch * An indication for surgery is present&#xD;
             when hormonal and/or analgesic therapy failed in suppressing pain symptoms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An mood, anxiety or personality disorder diagnosis according to the DSM-5 at the&#xD;
             moment of inclusion&#xD;
&#xD;
          -  Undergoing psychological treatment at the moment of inclusion&#xD;
&#xD;
          -  Use of psychopharmacologic medication aimed at altering mood at the moment of&#xD;
             inclusion Patients that have endometriosis-related unwanted childlessness only&#xD;
&#xD;
          -  Chronic pain (3 days a week for at least 6 months) that can be allocated to other&#xD;
             diseases or syndromes&#xD;
&#xD;
          -  Scalp hair shorter than 4 cm&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>A W Nap, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rijnstate</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Z Boersen, MSc</last_name>
    <phone>088 0056495</phone>
    <phone_ext>+31</phone_ext>
    <email>zboersen@rijnstate.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zoë Boersen, MSc</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Z Boersen, MSc</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <state>Noord-Brabant</state>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Z Boersen, MSc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>28911933</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29414035</PMID>
  </reference>
  <reference>
    <citation>Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.</citation>
    <PMID>15541453</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26851604</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24547801</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24520487</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23078196</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: J Pain. 2017 Apr;18(4):477.</citation>
    <PMID>26476267</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29793597</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>May 2, 2022</last_update_submitted>
  <last_update_submitted_qc>May 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>Cognitive behavioral therapy</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448366
org study id: 2019-1464
nct id: NCT04448366
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30
time frame: 7,5 months
description: 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.
measure: Change in general Quality of Life assessed by the Short Form 36
time frame: 7,5 months
description: 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.
measure: Change in Pain intensity assessed by the Numerical Rating Scale
time frame: 7,5 months
description: 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.
measure: Change in Subjective stress assessed by the Perceived Stress Scale
time frame: 7,5 months
description: 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.
measure: Change in Objective stress assessed by measuring scalp hair cortisol levels
time frame: 7,5 months
description: 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).
measure: Changes in pain cognitions assessed by the Pain anxiety symptom scale
time frame: 7,5 months
description: 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.
measure: Changes in pain cognitions assessed by the pain catastrophizing Scale
time frame: 7,5 months
description: 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
measure: Changes in Fatigue assessed by the checklist individual strength
time frame: 7,5 months
description: 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.
arm group label: Cognitive behavioral therapy group
arm group type: Experimental
description: Patients in this group will undergo a total of 7 sessions of CBT in 5 months in addition to usual care.
arm group label: Usual care
arm group type: No Intervention
description: Patients in this group will undergo usual care only.
intervention type: Behavioral
intervention name: Cognitive behavioral therapy
description: 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.
arm group label: Cognitive behavioral therapy group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: A W Nap, MSc, PhD
role: Principal Investigator
affiliation: Rijnstate
last name: Z Boersen, MSc
phone: 088 0056495
phone ext: +31
email: zboersen@rijnstate.nl
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Netherlands
citation: 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
citation: 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
citation: Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
PMID: 15541453
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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. Erratum In: J Pain. 2017 Apr;18(4):477.
PMID: 26476267
citation: 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
responsible party type: Sponsor
mesh term: Endometriosis
sharing ipd: No