Clinical trial NCT02352870: Intervention for Improving Psychological Distress in Dialysis
Official title: Intervention for Improving Psychological Distress in Dialysis (iDiD) Feasibility Two Arm Randomised Controlled Trial: Online Cognitive Behavioural Therapy (CBT) Intervention With Therapist Support vs Online CBT Intervention Alone (no Therapist Support)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Depression
Anxiety
Keywords: Feasibility study
Randomised controlled trial
Cognitive behavioural therapy
Psychological distress
Cognitive illness representations
Common sense model
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
name: University of Southampton
First posted: 2015-02-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or over and receive hospital haemodialysis three-times weekly
2. Presence of mild to moderately severe depressive symptoms (based on PHQ-9 scores of 5 to 19 in range; a self-report measure of depression) and/or presence of mild to moderate anxiety symptoms (based on GAD-7 scores of 5-14)
3. Speak English sufficiently well to engage with screening tools
4. Have a basic understanding of how to use the Internet and an email address
5. Have a minimum dialysis vintage of ≥3 months (electronic patient record)

Exclusion Criteria:

1. Hospitalised at the time of assessment or within 1 month prior to the assessment
2. Currently receiving active treatment for depression and/or anxiety. We consider active treatment to be any current psychological treatments (talking therapies) or receipt of a new anti-depressant and/or anti-anxiety medication. A medication is considered new if it is commenced three months prior to the completion of the depression and anxiety screening questionnaire
3. Severe mental health disorders, for example, psychosis, bi-polar disorder
4. Active suicidal thoughts-any participant that scores greater than one on the depression PHQ-9 item "Thoughts that you would be better off dead, or of hurting yourself" will be excluded from the study.
5. Evidence of addiction to alcohol or drugs

Primary outcomes:
measure: Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
timeFrame: Baseline recruitment/screening
Secondary outcomes:
measure: Recruitment , randomisation, and retention rates
timeFrame: Screening, baseline, and 12 weeks follow-up
measure: Adherence to the online intervention + telephone support calls (therapist supported arm only)
timeFrame: 12 weeks follow-up
measure: PHQ-9 (A self-report 9 item measure of depression)
timeFrame: Change in depression from baseline to 12 weeks
measure: GAD-7 (A self-report 7 item measure of anxiety)
timeFrame: Change in anxiety from baseline to 12 weeks
measure: EQ-5D (A self-report measure of quality of life)
timeFrame: Baseline and 12 weeks follow-up
measure: Brief Illness Perceptions Questionnaire
timeFrame: Baseline and 12 weeks follow-up
measure: Client Service Receipt Inventory (A self-report measure of health service utilisation)
timeFrame: Baseline and 12 weeks follow-up
measure: Satisfaction with treatment (A 2 item measure generated for the purposes of present study)
timeFrame: Baseline and 12 weeks follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Trust
Study officials:
affiliation: King's College London
name: Joseph Chilcot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudson JL, Moss-Morris R, Game D, Carroll A, Chilcot J. Improving Distress in Dialysis (iDiD): A tailored CBT self-management treatment for patients undergoing dialysis. J Ren Care. 2016 Dec;42(4):223-238. doi: 10.1111/jorc.12168. Epub 2016 Jul 26.
citation: Hudson JL, Moss-Morris R, Norton S, Picariello F, Game D, Carroll A, Spencer J, McCrone P, Hotopf M, Yardley L, Chilcot J. Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial. J Psychosom Res. 2017 Nov;102:61-70. doi: 10.1016/j.jpsychores.2017.09.009. Epub 2017 Sep 21.
citation: Chilcot J, Hudson JL, Moss-Morris R, Carroll A, Game D, Simpson A, Hotopf M. Screening for psychological distress using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS): Initial validation of structural validity in dialysis patients. Gen Hosp Psychiatry. 2018 Jan-Feb;50:15-19. doi: 10.1016/j.genhosppsych.2017.09.007. Epub 2017 Sep 28.