title: 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.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT023528702; Pre-results.
authors.affiliation: Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Joanna L
authors.initials: JL
authors.lastname: Hudson
authors.affiliation: Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Rona
authors.initials: R
authors.lastname: Moss-Morris
authors.affiliation: Guy's and St Thomas' NHS Trust, London, UK.
authors.forename: David
authors.initials: D
authors.lastname: Game
authors.affiliation: Guy's and St Thomas' NHS Trust, London, UK.
authors.forename: Amy
authors.initials: A
authors.lastname: Carroll
authors.affiliation: Health Services & Population Research, London, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.affiliation: Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Hotopf
authors.affiliation: Psychology Department, University of Southampton, Southampton, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Yardley
authors.affiliation: Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
authors.forename: Joseph
authors.initials: J
authors.lastname: Chilcot
mesh_terms: D000293:Adolescent; D000328:Adult; D001007:Anxiety / Q000628:therapy*; D001008:Anxiety Disorders; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003863:Depression / Q000628:therapy*; D003866:Depressive Disorder; D019468:Disease Management; D005260:Female; D006801:Humans; D020407:Internet; D007676:Kidney Failure, Chronic / Q000523:psychology* / Q000628:therapy; D008297:Male; D011613:Psychotherapy; D006435:Renal Dialysis / Q000523:psychology*; D013315:Stress, Psychological / Q000628:therapy*; D013689:Telephone; D006113:United Kingdom
keywords: STATISTICS & RESEARCH METHODS