Intervention for Improving Psychological Distress in Dialysis
NCT ID: NCT02352870
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2015-02-28
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Computerised CBT with therapist support
Participants complete seven online cognitive behavioural therapy sessions weekly plus they receive three telephone support calls. The content of each of the sessions are summarised below:
Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality.
Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future
In addition to completing the seven online sessions the intervention arm received three 30 minute telephone support calls at weeks two, four, and six to facilitate engagement and understanding of the contents of the website.
Computerised Cognitive Behavioural Therapy
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
Telephone support
Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.
Computerised CBT without therapist support
Participants complete seven online cognitive behavioural therapy sessions weekly but do not receive any telephone support calls. The content of each of the sessions are summarised below:
Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality.
Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future
Computerised Cognitive Behavioural Therapy
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
Interventions
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Computerised Cognitive Behavioural Therapy
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
Telephone support
Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
University of Southampton
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Joseph Chilcot, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Guy's and St Thomas NHS Trust
London, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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14.LO.1934
Identifier Type: OTHER
Identifier Source: secondary_id
PAHTMZA WPAH 68913
Identifier Type: -
Identifier Source: org_study_id