EndometriosisNCT04448366
Cognitive Behavioral Therapy in Endometriosis
A study testing Cognitive behavioral therapy in people with Endometriosis and Quality of Life, run by Rijnstate Hospital at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Quality of Life, Pain
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesNetherlands
- Study dates
- 24 Nov 2020to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, 5223GZ
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
Isala Hospital
Zwolle, Overijsel, 8025AB
About this study
Official title: 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).
Read the 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.
- Conditions
- Endometriosis, Quality of Life, Pain
- Being tested
- Cognitive behavioral therapy
- Keywords
- Endometriosis, Cognitive behavioral therapy, Quality of life
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive behavioral therapy |
| Usual care | No intervention | Patients in this group will undergo usual care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7,5 months
Secondary outcomes (6)
Change in Pain intensity assessed by the Numerical Rating Scale
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.
Measured: 7,5 months
Change in Subjective stress assessed by the Perceived Stress Scale
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.
Measured: 7,5 months
Change in Objective stress assessed by measuring scalp hair cortisol levels
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).
Measured: 7,5 months
Changes in pain cognitions assessed by the Pain anxiety symptom scale
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.
Measured: 7,5 months
Changes in pain cognitions assessed by the pain catastrophizing Scale
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
Measured: 7,5 months
Changes in Fatigue assessed by the checklist individual strength
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.
Measured: 7,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start24 Nov 2020
- Primary completion15 Aug 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Catharina Ziekenhuis Eindhoven, Jeroen Bosch Ziekenhuis, Isala
- Responsible party
- Sponsor
- Investigators
- A W Nap, MSc, PhD, Principal investigator, Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448366
- Sponsor's protocol ID
- 2019-1464
- Status last verified
- Nov 2024
- First submitted
- 3 Jun 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28911933van 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.
PubMed 29414035Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
PubMed 15541453Soliman 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.
PubMed 26851604Ehde 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.
PubMed 24547801Faramarzi 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.
PubMed 24520487Richter 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.
PubMed 23078196Archer 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.
PubMed 26476267Wang 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.
PubMed 29793597Boersen Z, Oosterman JM, Dijkhuizen FPHLJ, van Vliet HAAM, van der Steeg JW, Teklenburg G, Delcliseur HSMJ, Winter EG, de Schepper KAI, Dorothea DDM, Verhaak CM, Nap AW. Improving health-related quality of life in patients with endometriosis-related chronic pain: the COGENS trial. BMC Womens Health. 2026 Mar 12;26(1):209. doi: 10.1186/s12905-026-04340-2.
PubMed 41821023Boersen 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.
PubMed 34880026
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy to Improve Quality of Life After Surgical Treatment of Women With Endometriosis
- ClinicalTrials.gov ID
- NCT04448366
- Acronym / sponsor ID
- 2019-1464
- Conditions
- Endometriosis, Quality of Life, Pain
- Keywords
- Endometriosis, Cognitive behavioral therapy, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Catharina Ziekenhuis Eindhoven, Jeroen Bosch Ziekenhuis, Isala
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy group | Experimental | Behavioral: Cognitive behavioral therapyPatients in this group will undergo a total of 7 sessions of CBT in 5 months in addition to usual care. |
| Usual care | No intervention | –Patients in this group will undergo usual care only. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyPatients 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. | Behavioural | Cognitive behavioral therapy group |
Primary outcome
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.
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.
6 secondary outcomes
Change in Pain intensity assessed by the Numerical Rating Scale
Time frame: 7,5 months
Change in Subjective stress assessed by the Perceived Stress Scale
Time frame: 7,5 months
Change in Objective stress assessed by measuring scalp hair cortisol levels
Time frame: 7,5 months
Changes in pain cognitions assessed by the Pain anxiety symptom scale
Time frame: 7,5 months
Changes in pain cognitions assessed by the pain catastrophizing Scale
Time frame: 7,5 months
Changes in Fatigue assessed by the checklist individual strength
Time frame: 7,5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Background: PubMed 28911933van 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.
- Background: PubMed 29414035van 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.
- Background: PubMed 15541453Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5.
- Background: PubMed 26851604Soliman 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.
- Background: PubMed 24547801Ehde 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.
- Background: PubMed 24520487Faramarzi 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.
- Background: PubMed 23078196Richter 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.
- Background: PubMed 26476267Archer 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.
- Background: PubMed 29793597Wang 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.
- Derived from this study: PubMed 41821023Boersen Z, Oosterman JM, Dijkhuizen FPHLJ, van Vliet HAAM, van der Steeg JW, Teklenburg G, Delcliseur HSMJ, Winter EG, de Schepper KAI, Dorothea DDM, Verhaak CM, Nap AW. Improving health-related quality of life in patients with endometriosis-related chronic pain: the COGENS trial. BMC Womens Health. 2026 Mar 12;26(1):209. doi: 10.1186/s12905-026-04340-2.
- Derived from this study: PubMed 34880026Boersen 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.
- Individual participant dataSharing planned: No
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Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.
Endometriosis (Diagnosis)
RecruitingObservational study
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
Endometriosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A W Nap, MSc, PhD principal investigator
Rijnstate
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Endometriosis and Quality of Life, run by Rijnstate Hospital at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30 (time frame: 7,5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448366, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.