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
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
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
1-11
Hudson, J.
b655be13-14d3-4be1-bd84-e102748a0f20
Moss-Morris, R.
a502f58a-d319-49a6-8aea-9dde4efc871e
Game, D.
d4b16998-4492-4c6a-b4c0-2508003e18b4
Carroll, A.
604c10f9-5c27-434b-84e3-8749b6d9e327
McCrone, P.
46acaeda-f726-49ca-b83a-0ed61cac7f83
Hotopf, M.
2cbaf083-846d-4471-aa5d-49b67a114173
Yardley, L.
64be42c4-511d-484d-abaa-f8813452a22e
Chilcott, J.
52ffee2c-43f8-477c-9bbd-7877880dcecc
April 2016
Hudson, J.
b655be13-14d3-4be1-bd84-e102748a0f20
Moss-Morris, R.
a502f58a-d319-49a6-8aea-9dde4efc871e
Game, D.
d4b16998-4492-4c6a-b4c0-2508003e18b4
Carroll, A.
604c10f9-5c27-434b-84e3-8749b6d9e327
McCrone, P.
46acaeda-f726-49ca-b83a-0ed61cac7f83
Hotopf, M.
2cbaf083-846d-4471-aa5d-49b67a114173
Yardley, L.
64be42c4-511d-484d-abaa-f8813452a22e
Chilcott, J.
52ffee2c-43f8-477c-9bbd-7877880dcecc
Hudson, J., Moss-Morris, R., Game, D., Carroll, A., McCrone, P., Hotopf, M., Yardley, L. and Chilcott, J.
(2016)
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.
BMJ Open, 6 (e011286), .
(doi:10.1136/bmjopen-2016-011286).
Abstract
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
Text
BMJ Open-2016-Hudson-.pdf
- Version of Record
More information
Accepted/In Press date: 23 March 2016
e-pub ahead of print date: 12 April 2016
Published date: April 2016
Identifiers
Local EPrints ID: 393785
URI: http://eprints.soton.ac.uk/id/eprint/393785
PURE UUID: 8aee44e3-6bd6-4359-8ce9-d453629d7c16
Catalogue record
Date deposited: 05 May 2016 08:48
Last modified: 15 Mar 2024 03:00
Export record
Altmetrics
Contributors
Author:
J. Hudson
Author:
R. Moss-Morris
Author:
D. Game
Author:
A. Carroll
Author:
P. McCrone
Author:
M. Hotopf
Author:
J. Chilcott
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics