Internet-based Cognitive Behavioral Therapy for Improving Health-related Quality of Life in Patients with Endometriosis: Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2022 Apr 13

PMID 35414092

Authors

Kathrin Schubert

Johanna Lohse

Matthias Kalder

Volker Ziller

Cornelia Weise

Affiliations

Soon will be listed here.

Abstract

Background: The trial investigates the efficacy of internet-based cognitive behavioral therapy (iCBT) in improving health-related QoL in patients with endometriosis, which is a chronic gynecological condition affecting up to 15% of people with female-assigned reproductive organs. Endometriosis is stress-related and comes with various physical symptoms such as pelvic pain and infertility. It has a substantial impact on health-related quality of life (QoL), and mind-body interventions seem promising in reducing the psychological burden.

Methods: This is a monocentric randomized-controlled trial recruiting 120 patients with endometriosis. The intervention consists of eight iCBT modules focusing on psychoeducation, cognitive restructuring, pacing, and emotion regulation. Participants will receive written feedback from a trained therapist weekly. The comparator is a waitlist control group. All participants will be followed up 3 months after the intervention, and the intervention group will additionally be followed up 12 months after the intervention. Trial participants will not be blinded to the allocated trial arm. Primary outcome measures are endometriosis-related QoL, pain, and pain-related disability. Secondary outcomes include coping, illness representations, and psychological flexibility. Statistical analyses will be performed following intention-to-treat principles.

Discussion: This randomized-controlled trial is the first trial to test the efficacy of iCBT for improving endometriosis-related QoL. Potential predictor variables and key mechanisms in treatment will be investigated to enable further progression in medical and psychological care for patients with endometriosis.

Trial Registration: ClinicalTrials.gov , NCT05098444 Registered on October 28, 2021.

Citing Articles

Why We Need a Stronger Focus on Women's Health in Clinical Psychology and Psychological Treatment.

Weise C, Hajek Gross C Clin Psychol Eur. 2024; 6(3):e15683.

PMID: 39678315 PMC: 11636745. DOI: 10.32872/cpe.15683.

Holistic approaches to living well with endometriosis.

Desai J, Strong S, Ball E F1000Res. 2024; 13():359.

PMID: 39649833 PMC: 11621616. DOI: 10.12688/f1000research.142586.2.

Comprehensive endometriosis care: a modern multimodal approach for the treatment of pelvic pain and endometriosis.

Mick I, Freger S, van Keizerswaard J, Gholiof M, Leonardi M Ther Adv Reprod Health. 2024; 18:26334941241277759.

PMID: 39376635 PMC: 11457249. DOI: 10.1177/26334941241277759.

Psychological therapies delivered remotely for the management of chronic pain (excluding headache) in adults.

Rosser B, Fisher E, Janjua S, Eccleston C, Keogh E, Duggan G Cochrane Database Syst Rev. 2023; 8:CD013863.

PMID: 37643992 PMC: 10476013. DOI: 10.1002/14651858.CD013863.pub2.

Understanding Psychological Symptoms of Endometriosis from a Research Domain Criteria Perspective.

van Stein K, Schubert K, Ditzen B, Weise C J Clin Med. 2023; 12(12).

PMID: 37373749 PMC: 10299570. DOI: 10.3390/jcm12124056.

References

Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E . Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry. 2014; 13(3):288-95. PMC: 4219070. DOI: 10.1002/wps.20151. View

Pereira M, Ribeiro I, Ferreira H, Osorio F, Nogueira-Silva C, Almeida A . Psychological Morbidity in Endometriosis: A Couple's Study. Int J Environ Res Public Health. 2021; 18(20). PMC: 8535360. DOI: 10.3390/ijerph182010598. View

Bernardy K, Fuber N, Kollner V, Hauser W . Efficacy of cognitive-behavioral therapies in fibromyalgia syndrome - a systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2010; 37(10):1991-2005. DOI: 10.3899/jrheum.100104. View

Pluchino N, Wenger J, Petignat P, Tal R, Bolmont M, Taylor H . Sexual function in endometriosis patients and their partners: effect of the disease and consequences of treatment. Hum Reprod Update. 2016; 22(6):762-774. DOI: 10.1093/humupd/dmw031. View

Van Niekerk L, Weaver-Pirie B, Matthewson M . Psychological interventions for endometriosis-related symptoms: a systematic review with narrative data synthesis. Arch Womens Ment Health. 2019; 22(6):723-735. DOI: 10.1007/s00737-019-00972-6. View

Toth B . Stress, inflammation and endometriosis: are patients stuck between a rock and a hard place?. J Mol Med (Berl). 2010; 88(3):223-5. DOI: 10.1007/s00109-010-0595-4. View

Facchin F, Barbara G, Saita E, Mosconi P, Roberto A, Fedele L . Impact of endometriosis on quality of life and mental health: pelvic pain makes the difference. J Psychosom Obstet Gynaecol. 2015; 36(4):135-41. DOI: 10.3109/0167482X.2015.1074173. View

Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E . Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2017; 47(1):1-18. DOI: 10.1080/16506073.2017.1401115. View

Goncalves A, Barros N, Bahamondes L . The Practice of Hatha Yoga for the Treatment of Pain Associated with Endometriosis. J Altern Complement Med. 2016; 23(1):45-52. DOI: 10.1089/acm.2015.0343. View

10.

Strzempko Butt F, Chesla C . Relational patterns of couples living with chronic pelvic pain from endometriosis. Qual Health Res. 2007; 17(5):571-85. DOI: 10.1177/1049732307299907. View

11.

Delanerolle G, Ramakrishnan R, Hapangama D, Zeng Y, Shetty A, Elneil S . A systematic review and meta-analysis of the Endometriosis and Mental-Health Sequelae; The ELEMI Project. Womens Health (Lond). 2021; 17:17455065211019717. PMC: 8182632. DOI: 10.1177/17455065211019717. View

12.

Zheng P, Zhang W, Leng J, Lang J . Research on central sensitization of endometriosis-associated pain: a systematic review of the literature. J Pain Res. 2019; 12:1447-1456. PMC: 6514255. DOI: 10.2147/JPR.S197667. View

13.

Bond F, Hayes S, Baer R, Carpenter K, Guenole N, Orcutt H . Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011; 42(4):676-88. DOI: 10.1016/j.beth.2011.03.007. View

14.

Olliges E, Bobinger A, Weber A, Hoffmann V, Schmitz T, Popovici R . The Physical, Psychological, and Social Day-to-Day Experience of Women Living With Endometriosis Compared to Healthy Age-Matched Controls-A Mixed-Methods Study. Front Glob Womens Health. 2022; 2:767114. PMC: 8714740. DOI: 10.3389/fgwh.2021.767114. View

15.

Weise C, Kaiser G, Janda C, Kues J, Andersson G, Strahler J . Internet-Based Cognitive-Behavioural Intervention for Women with Premenstrual Dysphoric Disorder: A Randomized Controlled Trial. Psychother Psychosom. 2019; 88(1):16-29. DOI: 10.1159/000496237. View

16.

Carver C . You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997; 4(1):92-100. DOI: 10.1207/s15327558ijbm0401_6. View

17.

de C Williams A, Fisher E, Hearn L, Eccleston C . Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. 2020; 8:CD007407. PMC: 7437545. DOI: 10.1002/14651858.CD007407.pub4. View

18.

Lazzeri L, Orlandini C, Vannuccini S, Pinzauti S, Tosti C, Zupi E . Endometriosis and perceived stress: impact of surgical and medical treatment. Gynecol Obstet Invest. 2015; 79(4):229-33. DOI: 10.1159/000368776. View

19.

Ciharova M, Furukawa T, Efthimiou O, Karyotaki E, Miguel C, Noma H . Cognitive restructuring, behavioral activation and cognitive-behavioral therapy in the treatment of adult depression: A network meta-analysis. J Consult Clin Psychol. 2021; 89(6):563-574. DOI: 10.1037/ccp0000654. View

20.

Zarbo C, Brugnera A, Frigerio L, Malandrino C, Rabboni M, Bondi E . Behavioral, cognitive, and emotional coping strategies of women with endometriosis: a critical narrative review. Arch Womens Ment Health. 2017; 21(1):1-13. DOI: 10.1007/s00737-017-0779-9. View