Improving distress in dialysis (iDiD): a feasibility two-arm parallel randomised controlled trial of an online cognitive behavioural therapy intervention with and without therapist-led telephone support for psychological distress in patients undergoing haemodialysis
Open accessAbstract
INTRODUCTION: Psychological distress is common in end-stage kidney disease (ESKD) and is associated with poorer health outcomes. Cognitive behavioural therapy (CBT) is recommended in UK clinical guidelines for the management of depression in people with long-term conditions. Access to skilled therapists competent in managing the competing mental and physical health demands of ESKD is limited. Online CBT treatments tailored to the needs of the ESKD population offers a pragmatic solution for under-resourced services. This study examines the feasibility and acceptability of implementing a two-arm parallel randomised controlled trial of online CBT with (intervention arm) and without (control arm) therapist support to improve psychological distress in patients undergoing haemodialysis. METHODS: Patients will be screened for depression and anxiety while attending for their haemodialysis treatments. We aim to recruit 60 adult patients undergoing haemodialysis who meet criteria for mild to moderately severe symptoms of depression and/or anxiety. Patients will be randomised individually (using a 1:1 computerised sequence ratio) to either online CBT with therapist telephone support (intervention arm), or online CBT with no therapist (control arm). Outcomes include feasibility and acceptability descriptive data on rates of recruitment, randomisation, retention and treatment adherence. Self-report outcomes include measures of depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7), quality of life (Euro-QoL), service use (client service receipt inventory) and illness cognitions (brief illness perception questionnaire). A qualitative process evaluation will also be conducted. The statistician will be blinded to treatment allocation. ETHICS AND DISSEMINATION: A National Health Service (NHS) research ethics committee approved the study. Data from this study will provide essential information for the design and testing of further interventions to ameliorate distress in patients undergoing dialysis. Any amendments to the protocol will be submitted to the NHS committee and study sponsor. TRIAL REGISTRATION NUMBER: NCT023528702; Pre-results.
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Recent systematic reviews suggest that promising results can be obtained from web-based interventions for adults with chronic illnesses and depression.
“In addition, recent systematic reviews suggest that promising results can be obtained from web-based interventions for adults with chronic illnesses and depression.25–27”
From Acceptance and Commitment Therapy for Muscle Disease (ACTMus): Protocol for a two-arm randomised controlled trial of a brief guided self-help ACT programme for improving quality of life in people with muscle diseases (2018) · cites this paper as [27]
The Introduction (page unavailable) reports that guided self-help CBT is effective for psychological distress in people with physical health conditions. It also reports promising evidence for online treatments for depression and anxiety, but explicitly describes that evidence as concerning people without physical health conditions. The cited paper therefore does not establish the combined claim about web-based interventions for adults with chronic illnesses and depression. (LLM, conf=0.82)
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- Authors
- Hudson, J. L., Moss-Morris, R., Game, D., Carroll, A., McCrone, P., Hotopf, M., Yardley, L., & Chilcot, J.
- Affiliations
- King's College London (GB)
- Guy's and St Thomas' NHS Foundation Trust (GB)
- Health Services & Population Research, London, UK
- University of Southampton (GB)
- Corresponding author
- Chilcot, Joseph
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2016-04
- Volume
- 6
- Issue
- 4
- Pages
- e011286
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC4838682
- OpenAlex
- W2339019201
- Cited by
- 90
- References
- 38
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 5 · 2022: 8 · 2021: 5 · 2020: 50 · 2019: 7 · 2018: 3 · 2017: 3 · 2016: 4
- FWCI
- 8.73
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Portal (King's College London) (publishedVersion, cc-by-nc)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Explore Bristol Research (submittedVersion, cc-by-nc)
- UEA Digital Repository (University of East Anglia) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0515-10102)
- Guy's and St Thomas' Charity (EFT130206)
- King's College London
- Economic and Social Research Council (ES/F029624/1)
- Menzies Centre for Australian Studies, King's College London, University of London
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
- Keywords
- psychological distress, hemodialysis, end-stage renal disease, internet-based cognitive behavioral therapy, depression, anxiety, feasibility and acceptability, illness perception, quality of life, service utilization, medication adherence
- MeSH terms
- Adolescent, Adult, Anxiety, Anxiety Disorders, Depression, Depressive Disorder, Female, United Kingdom, Renal Dialysis, Humans, Kidney Failure, Chronic, Male, Psychotherapy, Stress, Psychological, Telephone, Cognitive Behavioral Therapy, Disease Management, Internet
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