Back to resultsIntervention for Improving Psychological Distress in Dialysis (iDiD)
Primary Purpose
Kidney Failure, Chronic, Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Computerised Cognitive Behavioural Therapy
Telephone support
Sponsored by
About this trial
This is an interventional other trial for Kidney Failure, Chronic focused on measuring Feasibility study, Randomised controlled trial, Cognitive behavioural therapy, Psychological distress, Cognitive illness representations, Common sense model
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or over and receive hospital haemodialysis three-times weekly
- 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)
- Speak English sufficiently well to engage with screening tools
- Have a basic understanding of how to use the Internet and an email address
- Have a minimum dialysis vintage of ≥3 months (electronic patient record)
Exclusion Criteria:
- Hospitalised at the time of assessment or within 1 month prior to the assessment
- 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
- Severe mental health disorders, for example, psychosis, bi-polar disorder
- 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.
- Evidence of addiction to alcohol or drugs
Sites / Locations
- Guy's and St Thomas NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computerised CBT with therapist support
Computerised CBT without therapist support
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
Record the number of patients approached for screening and their consent rate
Secondary Outcome Measures
Recruitment , randomisation, and retention rates
Descriptive statistics as per CONSORT flow diagram
Adherence to the online intervention + telephone support calls (therapist supported arm only)
Number of online sessions accessed and their duration + number of calls completed and their duration (therapist supported arm only)
PHQ-9 (A self-report 9 item measure of depression)
A self-report 9 item measure of depression
GAD-7 (A self-report 7 item measure of anxiety)
A self-report 7 item measure of anxiety
EQ-5D (A self-report measure of quality of life)
A self-report measure of quality of life
Brief Illness Perceptions Questionnaire
A self-report measure of beliefs about illness
Client Service Receipt Inventory (A self-report measure of health service utilisation)
A self-report measure of health service utilisation
Satisfaction with treatment (A 2 item measure generated for the purposes of present study)
A 2 item measure generated for the purposes of present study
Full Information
NCT ID
NCT02352870
First Posted
January 22, 2015
Last Updated
October 9, 2017
Sponsor
King's College London
Collaborators
National Health Service, United Kingdom, University of Southampton
1. Study Identification
Unique Protocol Identification Number
NCT02352870
Brief Title
Intervention for Improving Psychological Distress in Dialysis
Acronym
iDiD
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
National Health Service, United Kingdom, University of Southampton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Depression, Anxiety
Keywords
Feasibility study, Randomised controlled trial, Cognitive behavioural therapy, Psychological distress, Cognitive illness representations, Common sense model
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerised CBT with therapist support
Arm Type
Experimental
Arm Description
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.
Arm Title
Computerised CBT without therapist support
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Computerised Cognitive Behavioural Therapy
Intervention Description
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
Intervention Type
Behavioral
Intervention Name(s)
Telephone support
Intervention Description
Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.
Primary Outcome Measure Information:
Title
Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
Description
Record the number of patients approached for screening and their consent rate
Time Frame
Baseline recruitment/screening
Secondary Outcome Measure Information:
Title
Recruitment , randomisation, and retention rates
Description
Descriptive statistics as per CONSORT flow diagram
Time Frame
Screening, baseline, and 12 weeks follow-up
Title
Adherence to the online intervention + telephone support calls (therapist supported arm only)
Description
Number of online sessions accessed and their duration + number of calls completed and their duration (therapist supported arm only)
Time Frame
12 weeks follow-up
Title
PHQ-9 (A self-report 9 item measure of depression)
Description
A self-report 9 item measure of depression
Time Frame
Change in depression from baseline to 12 weeks
Title
GAD-7 (A self-report 7 item measure of anxiety)
Description
A self-report 7 item measure of anxiety
Time Frame
Change in anxiety from baseline to 12 weeks
Title
EQ-5D (A self-report measure of quality of life)
Description
A self-report measure of quality of life
Time Frame
Baseline and 12 weeks follow-up
Title
Brief Illness Perceptions Questionnaire
Description
A self-report measure of beliefs about illness
Time Frame
Baseline and 12 weeks follow-up
Title
Client Service Receipt Inventory (A self-report measure of health service utilisation)
Description
A self-report measure of health service utilisation
Time Frame
Baseline and 12 weeks follow-up
Title
Satisfaction with treatment (A 2 item measure generated for the purposes of present study)
Description
A 2 item measure generated for the purposes of present study
Time Frame
Baseline and 12 weeks follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or over and receive hospital haemodialysis three-times weekly
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)
Speak English sufficiently well to engage with screening tools
Have a basic understanding of how to use the Internet and an email address
Have a minimum dialysis vintage of ≥3 months (electronic patient record)
Exclusion Criteria:
Hospitalised at the time of assessment or within 1 month prior to the assessment
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
Severe mental health disorders, for example, psychosis, bi-polar disorder
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.
Evidence of addiction to alcohol or drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Chilcot, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas NHS Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27458126
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.
Results Reference
background
PubMed Identifier
28992899
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.
Results Reference
derived
PubMed Identifier
28985589
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.
Results Reference
derived
Learn more about this trial
Intervention for Improving Psychological Distress in Dialysis
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