Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000103763
Ethics application status
Approved
Date submitted
24/01/2013
Date registered
25/01/2013
Date last updated
25/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Studying an online educational course for supporting emotional health of dialysis patients
Scientific title
An open trial of examining the efficacy and acceptability of an internet-delivered cognitive behaviour therapy (CBT) program for adult dialysis patients with symptoms of anxiety and depression.
Secondary ID [1] 281778 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease

 288098 0
Anxiety 288196 0
Depression 288197 0
Condition category
Condition code
Renal and Urogenital 288469 288469 0 0
Kidney disease
Mental Health 288470 288470 0 0
Depression
Mental Health 288471 288471 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 5 lessons of an Internet-delivered cognitive behaviour therapy (CBT)-based program (the Wellbeing Course) focusing on the management of symptoms of anxiety, depression and disability. One lesson will be completed every 7 to 10 days. Each lesson will take about 15 minutes to complete. Participants will also have access to summaries of each lesson, and will read anonymous stories about other people who are doing dialysis with symptoms of depression and anxiety, taking a further 20 minutes per summary. All participants will also receive email and weekly reminder phone calls by a clinical psychologist. The duration of the reminder emails and phone calls is expected to be 5-10 minutes per week. The duration of the program is 8 weeks. Screening questionnaires will be administered at recruitment. Study questionnaires will be administered at pre-program, post-program, and at 3-months post-program. These will take about 10-20 minutes to complete.
Intervention code [1] 286320 0
Treatment: Other
Intervention code [2] 286398 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288629 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression
Timepoint [1] 288629 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [2] 288630 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety
Timepoint [2] 288630 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Primary outcome [3] 288631 0
Sheehan Disability Scale (SDS), which is a measure of disability
Timepoint [3] 288631 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [1] 300662 0
Kessler-10 item (K-10) which is a measure of mental health
Timepoint [1] 300662 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [2] 300663 0
SF12v2 Health Survey which is a measure of quality of life
Timepoint [2] 300663 0
Administered at pre-treatment, post-treatment, and at 3-months post-treatment
Secondary outcome [3] 300823 0
Kidney Disease Loss Scale which is a measure of affective and cognitive responses of loss related to kidney disease
Timepoint [3] 300823 0
Administered at pre-treatment, post-treatment, and at 3-month post-treatment
Secondary outcome [4] 300824 0
Burden of Kidney Disease Subscale of KDQoL-SF which is a measure of the perceptions of frustion and interference of kidney disease in one's life
Timepoint [4] 300824 0
Administered at pre-treatment, post-treatment, and at 3-month psot-treatment

Eligibility
Key inclusion criteria
receiving dialysis treatments for 6 months or more
internet access
Australian resident
have a total score >4 on PHQ9
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychotic disorder
Current or planned psychological treatment during study duration

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286562 0
Hospital
Name [1] 286562 0
Renal Unit
Liverpool Hospital
Country [1] 286562 0
Australia
Primary sponsor type
Hospital
Name
Renal Unit, Liverpool Hospital
Address
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 285345 0
University
Name [1] 285345 0
eCentreClinic, The Centre For Emotional Health (CEH), Department of Psychology, Macquarie University.
Address [1] 285345 0
Macquarie University, Balaclava Road, North Ryde, NSW, 2109, Australia.
Country [1] 285345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288630 0
SWSLHD Human Research Ethics Committee
Ethics committee address [1] 288630 0
Locked Bag 7279
Liverpool BC
NSW 1871
Ethics committee country [1] 288630 0
Australia
Date submitted for ethics approval [1] 288630 0
23/04/2012
Approval date [1] 288630 0
16/07/2012
Ethics approval number [1] 288630 0
HREC/12/LPOOL/144

Summary
Brief summary
This study is to evaluate the feasibility, effectiveness, and acceptability of an internet-delivered treatment program for depression and anxiety amongst dialysis patients using an open trial design (pilot study). The study also aims at modifying the content and materials to enhance the treatment acceptability and effectiveness by obtaining participants’ feedback and incorporating the evidence-based components specific to dialysis patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37054 0
Dr Ramony Chan
Address 37054 0
Dr Ramony Chan
Consultation Liaison Psychiatry
Locked Bag 7103
Liverpool BC
NSW 1871
Country 37054 0
Australia
Phone 37054 0
61 2 8738 8771
Fax 37054 0
Email 37054 0
[email protected]
Contact person for public queries
Name 37055 0
Ramony Chan
Address 37055 0
Consultation Liaison Psychiatry
Locked Bag 7103
Liverpool BC
NSW 1871
Country 37055 0
Australia
Phone 37055 0
61 2 8738 8771
Fax 37055 0
Email 37055 0
[email protected]
Contact person for scientific queries
Name 37056 0
Ramony Chan
Address 37056 0
Consultation Liaison Psychiatry
Locked Bag 7103
Liverpool BC
NSW 1871
Country 37056 0
Australia
Phone 37056 0
61 2 8738 8771
Fax 37056 0
Email 37056 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExamining internet-delivered cognitive behaviour therapy for patients with chronic kidney disease on haemodialysis: A feasibility open trial.2016https://dx.doi.org/10.1016/j.jpsychores.2016.08.012
N.B. These documents automatically identified may not have been verified by the study sponsor.