scholarly journals P517. Cognitive-behavioural therapy has no effect on disease activity but it improves quality of life in sub-groups of patients with inflammatory bowel disease short-term: a randomised controlled trial with a 24-month follow-up

2016 ◽  
Vol 10 (suppl 1) ◽  
pp. S362.2-S362
2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Micol Artom ◽  
Wladyslawa Czuber-Dochan ◽  
Jackie Sturt ◽  
Hannah Proudfoot ◽  
Danniella Roberts ◽  
...  

Abstract Background Fatigue is the third most prevalent symptom for patients with inflammatory bowel disease (IBD), yet optimal strategies for its management are unclear. Treatment protocols for fatigue in other conditions have been based on cognitive-behavioural models. Targeting cognitions, emotions and behaviour related to fatigue through cognitive-behavioural therapy (CBT) may be a viable option to improve fatigue and quality of life (QoL) in IBD. Methods This single centre, two-arm, feasibility randomised controlled trial (RCT) aimed to assess the feasibility and initial estimates of potential efficacy of a CBT intervention for the management of IBD-fatigue. Feasibility, acceptability and initial estimates of potential efficacy outcomes were collected through self-report measures and semi-structured interviews. Participants were recruited from one tertiary referral centre. Intervention Group 1 received a CBT manual for fatigue, one 60-min and seven 30-min telephone sessions with a therapist over 8-weeks. Control Group 2 received a fatigue information sheet without therapist support. A nested qualitative study evaluated patients’ and therapists’ experiences, and IBD-healthcare professionals’ (HCPs) perceptions of the intervention. Results Eighty-nine participants were assessed for eligibility. Of these, 31 of the 70 eligible participants consented to participate (recruitment rate of 44%). Of the 15 participants randomised to the intervention group, 13 (87%) started it and 10 (77% of those who started) completed all 8 sessions. Follow-up questionnaires were completed by 22 (71%) participants at 3 months, 14 (45%) at 6 months and 12 (39%) at 12 months’ follow-up. The intervention was acceptable to participants and feasible for therapists to deliver. HCPs reported that the intervention would be applicable, but time, finance and training constraints limit its implementation. Initial estimates of potential efficacy with complete case analysis showed a reduction in fatigue and an increase in QoL at 3, 6 and 12 months post-randomisation. Conclusions A full-scale effectiveness RCT testing CBT for IBD-fatigue is feasible and is potentially worthwhile with some changes to the protocol. However, given the small numbers, further pilot work is warranted before a full-scale RCT. Trial registration Registration Trial ISRCTN 17917944, Registered 2 September 2016


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046603
Author(s):  
Antonina Mikocka-Walus ◽  
Marilla Druitt ◽  
Melissa O'Shea ◽  
David Skvarc ◽  
Jennifer J Watts ◽  
...  

IntroductionEndometriosis is a debilitating chronic inflammatory condition highly burdensome to the healthcare system. The present trial will establish the efficacy of (1) yoga and (2) cognitive–behavioural therapy (CBT), above (3) education, on quality of life, biopsychosocial outcomes and cost-effectiveness.Methods and analysisThis study is a parallel randomised controlled trial. Participants will be randomly allocated to yoga, CBT or education. Participants will be English-speaking adults, have a diagnosis of endometriosis by a qualified physician, with pain for at least 6 months, and access to internet. Participants will attend 8 weekly group CBT sessions of 120 min; or 8 weekly group yoga sessions of 60 min; or receive weekly educational handouts on endometriosis. The primary outcome measure is quality of life. The analysis will include mixed-effects analysis of variance and linear models, cost–utility analysis from a societal and health system perspective and qualitative thematic analysis.Ethics and disseminationEnrolment in the study is voluntary and participants can withdraw at any time. Participants will be given the option to discuss the study with their next of kin/treating physician. Findings will be disseminated via publications, conferences and briefs to professional organisations. The University’s media team will also be used to further disseminate via lay person articles and media releases.Trial registration numberACTRN12620000756921p; Pre-results.


BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024307 ◽  
Author(s):  
Jesper Enander ◽  
Brjánn Ljótsson ◽  
Lina Anderhell ◽  
Martin Runeborg ◽  
Oskar Flygare ◽  
...  

ObjectivesMost patients with body dysmorphic disorder (BDD) do not receive evidence-based treatment. A randomised controlled trial (RCT) has found that a therapist-guided internet-based cognitive–behavioural therapy (CBT) programme for BDD (BDD-NET) can be delivered safely via the internet with significant improvements in BDD symptom severity in the short term. The purpose of this study was to evaluate if the therapeutic gains of BDD-NET are maintained 2 years after treatment.SettingAcademic medical centre.ParticipantsA naturalistic 2-year follow-up study of the 88 self-referred adult outpatients with a diagnosis of BDD that had received BDD-NET within the context of the RCT.Primary and secondary outcomesThe primary outcome was the BDD-Yale-Brown Obsessive-Compulsive Scale (YBOCS). Responder status was defined as a ≥30% reduction in symptoms. Remission was defined as no longer meeting Diagnostic and Statistical Manual of Mental Disorders 5th edition criteria for BDD. Secondary outcomes included measures of depression, global functioning and quality of life.ResultsThe efficacy of BDD-NET was sustained long- term, with further improvements observed on the BDD-YBOCS during the follow-up period. At follow-up, 69% (95% CI 57% to 80%) were classified as responders and 56% (95% CI 43% to 69%) were in remission. Gains on depressive symptoms and global functioning were also sustained but not quality of life. A majority of participants reported that the main reason for seeking help for their BDD was the possibility to access the treatment from home.ConclusionBDD-NET is an effective treatment for BDD, and the patients’ gains are maintained in the long term. BDD-NET has the potential to increase access to CBT and may lower the threshold for BDD sufferers to seek help in the first place.Trial registration numberNCT02010619.


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